Trial Outcomes & Findings for Saxenda in Obesity Services (STRIVE Study) (NCT NCT03036800)
NCT ID: NCT03036800
Last Updated: 2024-08-13
Results Overview
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
COMPLETED
PHASE4
392 participants
52 weeks
2024-08-13
Participant Flow
Participant milestones
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
260
|
132
|
|
Overall Study
Week 16
|
252
|
117
|
|
Overall Study
Week 32
|
243
|
113
|
|
Overall Study
Week 52
|
237
|
110
|
|
Overall Study
Week 104
|
215
|
104
|
|
Overall Study
COMPLETED
|
201
|
93
|
|
Overall Study
NOT COMPLETED
|
59
|
39
|
Reasons for withdrawal
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Non-compliance
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Tolerance
|
5
|
0
|
|
Overall Study
Unknown/no reason given
|
50
|
39
|
Baseline Characteristics
Saxenda in Obesity Services (STRIVE Study)
Baseline characteristics by cohort
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Total
n=392 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
228 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Continuous
|
51.10 years
STANDARD_DEVIATION 10.81 • n=99 Participants
|
51.81 years
STANDARD_DEVIATION 10.77 • n=107 Participants
|
51.34 years
STANDARD_DEVIATION 10.79 • n=206 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
225 Participants
n=99 Participants
|
114 Participants
n=107 Participants
|
339 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
11 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed/Other
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Weight
|
129.02 Kg
STANDARD_DEVIATION 25.33 • n=99 Participants
|
127.09 Kg
STANDARD_DEVIATION 21.42 • n=107 Participants
|
128.37 Kg
STANDARD_DEVIATION 24.08 • n=206 Participants
|
|
BMI
|
46.22 Kg/m2
STANDARD_DEVIATION 7.75 • n=99 Participants
|
45.52 Kg/m2
STANDARD_DEVIATION 7.25 • n=107 Participants
|
45.99 Kg/m2
STANDARD_DEVIATION 7.58 • n=206 Participants
|
|
Heart Rate
|
78.27 Beats/minute
STANDARD_DEVIATION 11.21 • n=99 Participants
|
78.37 Beats/minute
STANDARD_DEVIATION 12.24 • n=107 Participants
|
78.30 Beats/minute
STANDARD_DEVIATION 11.55 • n=206 Participants
|
|
Waist Circumference
|
132.44 Centimetre
STANDARD_DEVIATION 15.56 • n=99 Participants
|
131.81 Centimetre
STANDARD_DEVIATION 12.95 • n=107 Participants
|
132.23 Centimetre
STANDARD_DEVIATION 14.73 • n=206 Participants
|
|
HbA1c mmol/mol
|
46.10 Mmol/mol
STANDARD_DEVIATION 13.72 • n=99 Participants
|
44.71 Mmol/mol
STANDARD_DEVIATION 10.79 • n=107 Participants
|
45.64 Mmol/mol
STANDARD_DEVIATION 12.82 • n=206 Participants
|
|
HbA1c %
|
6.36 %
STANDARD_DEVIATION 1.27 • n=99 Participants
|
6.24 %
STANDARD_DEVIATION 0.99 • n=107 Participants
|
6.32 %
STANDARD_DEVIATION 1.18 • n=206 Participants
|
|
Systolic Blood Pressure
|
135.77 mmHg
STANDARD_DEVIATION 18.26 • n=99 Participants
|
138.12 mmHg
STANDARD_DEVIATION 17.79 • n=107 Participants
|
136.56 mmHg
STANDARD_DEVIATION 18.12 • n=206 Participants
|
|
Diastolic Blood Pressure
|
81.35 mmHg
STANDARD_DEVIATION 10.94 • n=99 Participants
|
81.99 mmHg
STANDARD_DEVIATION 12.04 • n=107 Participants
|
81.57 mmHg
STANDARD_DEVIATION 11.31 • n=206 Participants
|
|
LDL Cholesterol
|
2.71 mmol/L
STANDARD_DEVIATION 0.84 • n=99 Participants
|
2.70 mmol/L
STANDARD_DEVIATION 0.83 • n=107 Participants
|
2.71 mmol/L
STANDARD_DEVIATION 0.84 • n=206 Participants
|
|
HDL Cholesterol
|
1.24 mmol/L
STANDARD_DEVIATION 0.30 • n=99 Participants
|
1.25 mmol/L
STANDARD_DEVIATION 0.55 • n=107 Participants
|
1.24 mmol/L
STANDARD_DEVIATION 0.40 • n=206 Participants
|
|
Total Cholesterol
|
4.76 mmol/L
STANDARD_DEVIATION 1.00 • n=99 Participants
|
4.74 mmol/L
STANDARD_DEVIATION 0.95 • n=107 Participants
|
4.75 mmol/L
STANDARD_DEVIATION 0.98 • n=206 Participants
|
|
Triglycerides
|
1.85 mmol/L
STANDARD_DEVIATION 0.94 • n=99 Participants
|
1.86 mmol/L
STANDARD_DEVIATION 0.94 • n=107 Participants
|
1.85 mmol/L
STANDARD_DEVIATION 0.94 • n=206 Participants
|
|
Average total MET
|
5246.83 Minutes/week
STANDARD_DEVIATION 7145.63 • n=99 Participants
|
5463.48 Minutes/week
STANDARD_DEVIATION 7958.59 • n=107 Participants
|
5318.24 Minutes/week
STANDARD_DEVIATION 7412.94 • n=206 Participants
|
|
Smoking status
Never smoker
|
144 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
|
Smoking status
Ex-smoker
|
90 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Smoking status
Current smoker
|
25 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Smoking status
Missing
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Glycaemic Status
Normogylcaemia
|
110 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
176 Participants
n=206 Participants
|
|
Glycaemic Status
Prediabetes
|
42 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Glycaemic Status
Diabetes remission
|
9 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Glycaemic Status
Diabetes
|
98 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Glycaemic Status
Missing
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Hypertension Status
Yes
|
162 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
250 Participants
n=206 Participants
|
|
Hypertension Status
No
|
96 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Hypertension Status
Missing
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sleep Apnoea Status
Yes
|
124 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Sleep Apnoea Status
No
|
113 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Sleep Apnoea Status
Missing
|
23 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Number of all Medications
None
|
55 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Number of all Medications
One
|
24 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Number of all Medications
Two
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Number of all Medications
Three
|
32 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Number of all Medications
Four
|
24 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Number of all Medications
Five and over
|
108 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Number of Diabetes Medications
Does not have diabetes
|
162 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Number of Diabetes Medications
None
|
35 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Number of Diabetes Medications
One
|
52 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Number of Diabetes Medications
Two
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Number of Diabetes Medications
Three and over
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Number of Antihypertensive Medications
Does not have hypertension
|
98 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Number of Antihypertensive Medications
None
|
44 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Number of Antihypertensive Medications
One
|
55 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Number of Antihypertensive Medications
Two
|
33 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Number of Antihypertensive Medications
Three and over
|
30 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Statin Use
Yes
|
70 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Statin Use
No
|
190 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
291 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=201 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Complete Cases)
|
51 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Intention to Treat)
|
55 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Per protocol population All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=108 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=51 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Per Protocol)
|
40 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Per protocol population. All participants who were compliant with their randomised treatment, analysed according to the treatment group to which they were randomised. Standard care group are compliant if they complete \>70% of the planned contacts in the T3 service. The intervention group are compliant if they complete \>70% of the planned contacts in the T3 service, and take \>70% of their prescribed LIRA 3mg. Excludes participants who had bariatric surgery during the study period.
Proportion of participants with severe and complicated obesity achieving weight loss of ≥15% at 52 weeks with the use of a targeted prescribing pathway (i.e. use of LIRA 3mg according to a pre-specified protocol in combination with standard care provided in Tier 3 services) versus standard care alone in a Tier 3 service.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=105 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=50 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Per Protocol Without Excluded Concomitant Medications)
|
40 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Attended at least 70% of scheduled Tier 3 appointments by 52 weeks
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Participant Attendance at Appointments (Intention to Treat)
No
|
0 Participants
|
1 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Yes
|
115 Participants
|
51 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Did not attend week 52 visit
|
60 Participants
|
43 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Attended week 52 visit but variable missing
|
85 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Attended at least 70% of scheduled Tier 3 appointments by 104 weeks
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Participant Attendance at Appointments (Intention to Treat)
No
|
0 Participants
|
0 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Yes
|
92 Participants
|
46 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Did not attend week 104 visit
|
117 Participants
|
66 Participants
|
|
Participant Attendance at Appointments (Intention to Treat)
Attended week 104 visit but variable missing
|
51 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 52 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
No
|
111 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Yes
|
3 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
N/A
|
146 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
This is for Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant stopped treatment with liraglutide 3mg by 104 weeks because of adverse effects (i.e., the main reason for stopping was listed as 'adverse event' or 'unable to tolerate drug'). This number does not include people who stopped treatment due to a stopping rule or reason other than an adverse effect. Only defined for participants who were currently eligible for liraglutide 3mg treatment. Participants may have stopped treatment due to adverse effects at an earlier timepoint and so the total number of 'yes' and 'no' responses is higher than the number eligible for liraglutide 3mg at the analysis time-point, i.e. if a participant stopped at week 16 due to adverse events then they would still be included in the 'yes' response.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
No
|
53 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Yes
|
2 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
N/A
|
205 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Cessation of Treatment Due to Adverse Effects (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
This is for Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 52 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Participant Compliance With Treatment (Intention to Treat)
No
|
23 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Participant Compliance With Treatment (Intention to Treat)
Yes
|
233 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Participant Compliance With Treatment (Intention to Treat)
Missing
|
4 Participants
|
NA Participants
This is for Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant was compliant with liraglutide 3mg treatment up to 104 weeks. This was defined using the questionnaire answers as detailed in Appendix 7 of the SAP, and so includes all participants (i.e., not only those who attended the visit) up to the point when they stopped treatment or withdrew from the study.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Participant Compliance With Treatment (Intention to Treat)
No
|
27 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Participant Compliance With Treatment (Intention to Treat)
Yes
|
229 Participants
|
NA Participants
This is for Liraglutide arm only.
|
|
Participant Compliance With Treatment (Intention to Treat)
Missing
|
4 Participants
|
NA Participants
This is for Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 16 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Patient Stopping of Treatment (Intention to Treat)
No
|
181 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Yes
|
79 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
For Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 32 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=181 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Patient Stopping of Treatment (Intention to Treat)
No
|
110 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Yes
|
71 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
For Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who were on liraglutide 3mg treatment at the previous time-point.
Derived binary indicator showing whether participant had stopped treatment with liraglutide 3mg at 52 weeks (due to stopping rules or other reason, such as an adverse event despite passing the stopping rule). Only defined for participants who were on liraglutide 3mg treatment at the previous time-point.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=110 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Patient Stopping of Treatment (Intention to Treat)
No
|
53 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Yes
|
57 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Patient Stopping of Treatment (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
For Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 16 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
No
|
60 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Yes
|
19 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
N/A (still using Liraglutide 3mg at 16 weeks)
|
181 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 16 Weeks (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
For Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population. Only includes participants who stopped liraglutide 3mg treatment at 32 weeks.
Derived binary indicator showing whether participant completed 52 weeks of the Tier 3 service programme despite stopping liraglutide 3mg at 32 weeks (due to stopping rules or other reason). Only defined for participants who stopped liraglutide 3mg treatment at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=181 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
No
|
49 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Yes
|
22 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
N/A (still using Liraglutide 3mg at 32 weeks)
|
110 Participants
|
NA Participants
For Liraglutide arm only.
|
|
Completion of Tier 3 Despite Liraglutide Cessation by 32 Weeks (Intention to Treat)
Missing
|
0 Participants
|
NA Participants
For Liraglutide arm only.
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
No
|
203 Participants
|
92 Participants
|
|
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Yes
|
3 Participants
|
1 Participants
|
|
Started on Anti-obesity Drugs at 52 Weeks (Intention to Treat)
Missing
|
54 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Derived binary indicator showing whether participant started on anti-obesity drugs other than liraglutide (defined as a concomitant medication listing of Orlistat) at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
No
|
144 Participants
|
64 Participants
|
|
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Yes
|
3 Participants
|
2 Participants
|
|
Started on Anti-obesity Drugs at 104 Weeks (Intention to Treat)
Missing
|
113 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Number of participants referred to Tier 4 for bariatric surgery over the 104 weeks study period
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Referral to Other Obesity Interventions (Intention to Treat)
No
|
125 Participants
|
64 Participants
|
|
Referral to Other Obesity Interventions (Intention to Treat)
Yes
|
25 Participants
|
5 Participants
|
|
Referral to Other Obesity Interventions (Intention to Treat)
Missing
|
110 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed. Participants who had bariatric surgery during the study period were included in this population.
Referrals for bariatric surgery by 104 weeks, stratified by study site.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
Dublin
|
3 Participants
|
3 Participants
|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
Glasgow
|
0 Participants
|
0 Participants
|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
Leicester
|
10 Participants
|
0 Participants
|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
Liverpool
|
2 Participants
|
1 Participants
|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
London
|
10 Participants
|
1 Participants
|
|
Referral to Other Obesity Interventions by Site (Intention to Treat)
Not referred / missing
|
235 Participants
|
127 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Intention to Treat population (ITT). The ITT population was all randomised participants and they were analysed according to the treatment group to which they were randomised at baseline. Missing outcome data were imputed.
Number of participants who underwent bariatric surgery by 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Bariatric Surgery Completion (Intention to Treat)
No
|
142 Participants
|
64 Participants
|
|
Bariatric Surgery Completion (Intention to Treat)
Yes
|
6 Participants
|
4 Participants
|
|
Bariatric Surgery Completion (Intention to Treat)
Missing
|
112 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline, at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=237 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Complete Cases)
|
186 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline, at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=208 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Complete Cases)
|
158 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline, at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=201 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Complete Cases)
|
127 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline, at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Complete Cases)
|
62 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline, at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=237 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Complete Cases)
|
60 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline, at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=208 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Complete Cases)
|
110 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline, at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=201 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Complete Cases)
|
90 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline, at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Complete Cases)
|
32 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=237 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Complete Cases)
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=208 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Complete Cases)
|
32 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Complete Cases)
|
15 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Proportion of participants maintaining weight loss of ≥15% among those who lost ≥15% at 52 weeks
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=41 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=5 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Maintenance of ≥15% Weight Loss Until 104 Weeks (Complete Cases)
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in weight (kg) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=237 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Weight Change (Complete Cases)
|
-9.61 kg
Standard Deviation 5.38
|
-5.54 kg
Standard Deviation 5.87
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in weight (kg) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=208 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Weight Change (Complete Cases)
|
-11.27 kg
Standard Deviation 7.70
|
-5.70 kg
Standard Deviation 7.16
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in weight (kg) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=201 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Weight Change (Complete Cases)
|
-10.15 kg
Standard Deviation 9.45
|
-3.21 kg
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in weight (kg) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Weight Change (Complete Cases)
|
-6.51 kg
Standard Deviation 9.28
|
-1.27 kg
Standard Deviation 10.30
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=237 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Complete Cases)
|
-7.63 percentage
Standard Deviation 4.02
|
-4.39 percentage
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=208 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Complete Cases)
|
-9.00 percentage
Standard Deviation 5.82
|
-4.58 percentage
Standard Deviation 5.74
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=201 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Complete Cases)
|
-8.13 percentage
Standard Deviation 7.21
|
-2.67 percentage
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Complete Cases)
|
-5.18 percentage
Standard Deviation 7.47
|
-1.21 percentage
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in BMI (kg/m2) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=180 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=80 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute BMI Change (Complete Cases)
|
-3.84 kg/m2
Standard Deviation 3.29
|
-1.17 kg/m2
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in BMI (kg/m2) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=132 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute BMI Change (Complete Cases)
|
-2.30 kg/m2
Standard Deviation 3.29
|
-0.49 kg/m2
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in waist circumference (cm) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=137 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=58 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Waist Circumference Change (Complete Cases)
|
-8.88 Centimetres
Standard Deviation 7.89
|
-5.58 Centimetres
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: 104 weeksAbsolute change in waist circumference (cm) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=101 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=48 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Waist Circumference Change (Complete Cases)
|
-6.42 Centimetres
Standard Deviation 8.44
|
-0.93 Centimetres
Standard Deviation 12.54
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=145 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=63 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Normal health at baseline
|
0 Participants
|
0 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Normal health at follow-up
|
1 Participants
|
0 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
At risk of disease at baseline
|
6 Participants
|
5 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
At risk of disease at follow-up
|
23 Participants
|
12 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Established disease at baseline
|
97 Participants
|
41 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Established disease at follow-up
|
108 Participants
|
43 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Advanced disease at baseline
|
42 Participants
|
17 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Advanced disease at follow-up
|
13 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Kings College Obesity Staging (KCOS) score; range 0 to 3. A higher value corresponds with higher complications and worse outcomes.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=115 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=51 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Normal health at baseline
|
0 Participants
|
0 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Normal health at follow-up
|
2 Participants
|
0 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
At risk of disease at baseline
|
5 Participants
|
4 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
At risk of disease at follow-up
|
16 Participants
|
10 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Established disease at baseline
|
84 Participants
|
37 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Established disease at follow-up
|
86 Participants
|
35 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Advanced disease at baseline
|
26 Participants
|
10 Participants
|
|
Kings College Obesity Staging (KCOS) Score (Complete Cases)
Advanced disease at follow-up
|
11 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=139 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=63 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Patient Health Questionnaire-9 (Complete Cases)
Minimal depression at baseline
|
27 Participants
|
16 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Minimal depression at follow-up
|
48 Participants
|
24 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Mild depression at baseline
|
33 Participants
|
15 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Mild depression at follow-up
|
30 Participants
|
9 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderate depression at baseline
|
29 Participants
|
23 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderate depression at follow-up
|
27 Participants
|
14 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderately severe depression at baseline
|
32 Participants
|
2 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderately severe depression at follow-up
|
18 Participants
|
6 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Severe depression at baseline
|
18 Participants
|
7 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Severe depression at follow-up
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Patient health questionnaire-9 (PHQ-9) score; range 0 to 27. A higher value corresponds with higher complications and worse outcomes.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=102 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=50 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Patient Health Questionnaire-9 (Complete Cases)
Minimal depression at baseline
|
19 Participants
|
15 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Minimal depression at follow-up
|
32 Participants
|
17 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Mild depression at baseline
|
27 Participants
|
10 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Mild depression at follow-up
|
26 Participants
|
16 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderate depression at baseline
|
20 Participants
|
18 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderate depression at follow-up
|
21 Participants
|
10 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderately severe depression at baseline
|
23 Participants
|
3 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Moderately severe depression at follow-up
|
12 Participants
|
4 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Severe depression at baseline
|
13 Participants
|
4 Participants
|
|
Patient Health Questionnaire-9 (Complete Cases)
Severe depression at follow-up
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=145 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=62 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Epworth Sleepiness Scale (Complete Cases)
No obstructive sleep apnoea at baseline
|
111 Participants
|
47 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
No obstructive sleep apnoea at follow-up
|
119 Participants
|
50 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
Possible obstructive sleep apnoea at baseline
|
34 Participants
|
15 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
Possible obstructive sleep apnoea at follow-up
|
26 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Epworth sleepiness scale, used to diagnose obstructive sleep apnoea; scale 0 to 24. A higher value corresponds with a worse outcome.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=110 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=55 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Epworth Sleepiness Scale (Complete Cases)
No obstructive sleep apnoea at baseline
|
85 Participants
|
38 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
No obstructive sleep apnoea at follow-up
|
90 Participants
|
44 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
Possible obstructive sleep apnoea at baseline
|
25 Participants
|
17 Participants
|
|
Epworth Sleepiness Scale (Complete Cases)
Possible obstructive sleep apnoea at follow-up
|
20 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=93 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=44 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Stop Bang Questionnaire (Complete Cases)
No obstructive sleep apnoea at baseline
|
10 Participants
|
4 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
No obstructive sleep apnoea at follow-up
|
18 Participants
|
10 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Possible obstructive sleep apnoea at baseline
|
34 Participants
|
12 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Possible obstructive sleep apnoea at follow-up
|
43 Participants
|
14 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Likely obstructive sleep apnoea at baseline
|
49 Participants
|
28 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Likely obstructive sleep apnoea at follow-up
|
32 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Stop Bang questionnaire, used to diagnose obstructive sleep apnoea; scale 0 to 8. A higher value corresponds with a worse outcome.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=84 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=40 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Stop Bang Questionnaire (Complete Cases)
No obstructive sleep apnoea at baseline
|
11 Participants
|
3 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
No obstructive sleep apnoea at follow-up
|
12 Participants
|
4 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Possible obstructive sleep apnoea at baseline
|
26 Participants
|
13 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Possible obstructive sleep apnoea at follow-up
|
38 Participants
|
13 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Likely obstructive sleep apnoea at baseline
|
47 Participants
|
24 Participants
|
|
Stop Bang Questionnaire (Complete Cases)
Likely obstructive sleep apnoea at follow-up
|
34 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=165 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=56 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Glycaemic Status (Complete Cases)
Normoglycaemia at baseline
|
52 Participants
|
24 Participants
|
|
Glycaemic Status (Complete Cases)
Normoglycaemia at follow-up
|
67 Participants
|
24 Participants
|
|
Glycaemic Status (Complete Cases)
Prediabetes at baseline
|
21 Participants
|
9 Participants
|
|
Glycaemic Status (Complete Cases)
Prediabetes at follow-up
|
10 Participants
|
7 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes remission at baseline
|
8 Participants
|
2 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes remission at follow-up
|
0 Participants
|
2 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes at baseline
|
84 Participants
|
21 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes at follow-up
|
88 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases population The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period will be excluded from this population.
Glycaemic status, as determined by plasma glucose concentration. The glycaemic status definition states that a participant cannot be categorised as 'diabetes remission' if they are currently using liraglutide 3mg, which means that the absence of diabetes remission cases at follow-up in the intervention group is partly by definition of glycaemic status.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=101 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=46 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Glycaemic Status (Complete Cases)
Normoglycaemia at baseline
|
25 Participants
|
19 Participants
|
|
Glycaemic Status (Complete Cases)
Normoglycaemia at follow-up
|
31 Participants
|
15 Participants
|
|
Glycaemic Status (Complete Cases)
Prediabetes at baseline
|
13 Participants
|
7 Participants
|
|
Glycaemic Status (Complete Cases)
Prediabetes at follow-up
|
8 Participants
|
8 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes remission at baseline
|
5 Participants
|
1 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes remission at follow-up
|
0 Participants
|
1 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes at baseline
|
58 Participants
|
19 Participants
|
|
Glycaemic Status (Complete Cases)
Diabetes at follow-up
|
62 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants HbA1c ≤7% at 52 weeks, among those with diabetes at baseline.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=17 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
No
|
10 Participants
|
11 Participants
|
|
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Yes
|
44 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants HbA1c ≤7% at 104 weeks, among those with diabetes at baseline.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=39 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=17 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
No
|
10 Participants
|
10 Participants
|
|
HbA1c ≤7% for Those With Diabetes at Baseline (Complete Cases)
Yes
|
29 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants HbA1c ≤6.5% at 52 weeks, among those with diabetes at baseline.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=17 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
No
|
17 Participants
|
14 Participants
|
|
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Yes
|
37 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants HbA1c ≤6.5% at 104 weeks, among those with diabetes at baseline.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=39 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=17 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
No
|
16 Participants
|
12 Participants
|
|
HbA1c ≤6.5% for Those With Diabetes at Baseline (Complete Cases)
Yes
|
23 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants with hypertension at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=172 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=80 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Hypertension (Complete Cases)
Hypertension at baseline · No
|
37 Participants
|
20 Participants
|
|
Hypertension (Complete Cases)
Hypertension at baseline · Yes
|
135 Participants
|
60 Participants
|
|
Hypertension (Complete Cases)
Hypertension at follow-up · No
|
41 Participants
|
21 Participants
|
|
Hypertension (Complete Cases)
Hypertension at follow-up · Yes
|
131 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. The complete cases population is defined as all randomised participants who have data available for the outcome being analysed, according to the study group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants with hypertension at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=127 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=58 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Hypertension (Complete Cases)
Hypertension at baseline · No
|
35 Participants
|
16 Participants
|
|
Hypertension (Complete Cases)
Hypertension at baseline · Yes
|
92 Participants
|
42 Participants
|
|
Hypertension (Complete Cases)
Hypertension at follow-up · No
|
38 Participants
|
15 Participants
|
|
Hypertension (Complete Cases)
Hypertension at follow-up · Yes
|
89 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Responder Population)
|
54 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=53 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Responder Population)
|
53 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=51 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Responder Population)
|
51 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥5% from baseline at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥5% From Baseline (Responder Population)
|
33 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Responder Population)
|
34 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=53 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Responder Population)
|
53 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=51 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Responder Population)
|
51 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥10% from baseline at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥10% From Baseline (Responder Population)
|
23 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 16 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Responder Population)
|
8 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 32 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 32 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=53 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Responder Population)
|
24 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=51 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Responder Population)
|
51 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants reaching weight loss of ≥15% from baseline at 104 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Weight Loss of ≥15% From Baseline (Responder Population)
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Complete cases. All individuals in both arms (intervention and control group) who have data available for the outcome being analysed (proportion of participants who maintained at 104 weeks weight loss of \>=15% among those who lost \>=15% weight loss at 52 weeks) according to the study group to which they were randomised. Participants who had bariatric surgery during the study period were excluded from this population.
Proportion of participants who maintained weight loss of ≥15% among those who lost ≥15% at 52 weeks.
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=41 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=5 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Maintenance of ≥15% Weight Loss Until 104 Weeks (Responder Population)
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=54 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=86 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Responder Population)
|
-11.45 percentage
Standard Deviation 3.62
|
-4.39 percentage
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: 32 weeksPercentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=53 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=79 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Responder Population)
|
-14.82 percentage
Standard Deviation 3.85
|
-4.58 percentage
Standard Deviation 5.74
|
SECONDARY outcome
Timeframe: 52 weeksPercentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=51 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=93 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Responder Population)
|
-17.21 percentage
Standard Deviation 2.43
|
-2.67 percentage
Standard Deviation 6.79
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Percentage change in weight from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Percentage Weight Change (Responder Population)
|
-11.01 percentage
Standard Deviation 6.70
|
-1.21 percentage
Standard Deviation 8.16
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in BMI (kg/m2) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=50 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=80 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute BMI Change (Responder Population)
|
-7.65 kg/m2
Standard Deviation 1.65
|
-1.17 kg/m2
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in BMI (kg/m2) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=61 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute BMI Change (Responder Population)
|
-4.86 kg/m2
Standard Deviation 2.91
|
-0.49 kg/m2
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in waist circumference (cm) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=42 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=58 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Waist Circumference Change (Responder Population)
|
-15.33 Centimetres
Standard Deviation 6.02
|
-5.58 Centimetres
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: 104 weeksPopulation: Responder population The Responder population is defined as all participants in the intervention group who achieved ≥15% weight loss at 52 weeks, and all participants in the standard care group. Participants were analysed according to the treatment group to which they were randomised at baseline. Participants who had bariatric surgery during the study period were excluded from this population.
Absolute change in waist circumference (cm) from baseline
Outcome measures
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=34 Participants
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=48 Participants
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Absolute Waist Circumference Change (Responder Population)
|
-10.20 Centimetres
Standard Deviation 8.42
|
-0.93 Centimetres
Standard Deviation 12.54
|
Adverse Events
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
Standard Care Arm
Serious adverse events
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 participants at risk
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 participants at risk
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Surgical and medical procedures
Hernia Repair
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
General disorders
Febrile infection
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Vascular disorders
Haemorrhage
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Hepatobiliary disorders
Bile duct infections and inflammations
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Abdominal infection
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
2.3%
3/132 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.77%
2/260 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Immune system disorders
Anaphylactic reaction
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Nervous system disorders
Transient cerebrovascular event
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Reproductive system and breast disorders
Vulvovaginal disorder
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Endocrine disorders
Posterior pituitary disorder
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Renal and urinary disorders
Renal lithiasis
|
0.38%
1/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Investigations
Auscultation
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Cardiac disorders
Coronary artery disease
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal vascular occlusion and infarction
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
General disorders
Hernia
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
General disorders
Inflammation
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
General disorders
Pain
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.2%
3/260 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Female reproductive tract disorder
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Infection
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/260 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
1.5%
2/132 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Viral infection
|
1.2%
3/260 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Injury, poisoning and procedural complications
Injury
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural infection
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.76%
1/132 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Surgical and medical procedures
Nail operation
|
0.38%
1/260 • Number of events 1 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.77%
2/260 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
Other adverse events
| Measure |
Liraglutide Arm - Targeted Prescribing Pathway (LIRA 3mg + Standard Care)
n=260 participants at risk
Saxenda: standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose).
Plus specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
Standard Care Arm
n=132 participants at risk
Specialist Obesity Management Services: Specialist Obesity Management Services (Tier 3) - standard of care
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
27.7%
72/260 • Number of events 92 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
6.1%
8/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Ear infection
|
1.9%
5/260 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
7.6%
10/132 • Number of events 12 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.1%
34/260 • Number of events 43 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
11.4%
15/132 • Number of events 16 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Nervous system disorders
Headache
|
14.6%
38/260 • Number of events 49 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
1.5%
2/132 • Number of events 2 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
General disorders
Asthenic conditions
|
11.5%
30/260 • Number of events 32 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
2.3%
3/132 • Number of events 3 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.6%
38/260 • Number of events 44 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Flatulence
|
12.7%
33/260 • Number of events 39 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
0.00%
0/132 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
14.2%
37/260 • Number of events 48 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
3.8%
5/132 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
35.8%
93/260 • Number of events 117 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
9.1%
12/132 • Number of events 12 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Gastrointestinal disorders
Nausea
|
41.9%
109/260 • Number of events 183 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
3.8%
5/132 • Number of events 5 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Influenza
|
5.4%
14/260 • Number of events 15 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
3.8%
5/132 • Number of events 5 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Lower respiratory tract infection
|
15.8%
41/260 • Number of events 63 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
12.9%
17/132 • Number of events 22 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
18/260 • Number of events 19 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
6.1%
8/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Urinary tract infection
|
8.1%
21/260 • Number of events 26 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
3.8%
5/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Infections and infestations
Viral infection
|
13.8%
36/260 • Number of events 41 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
5.3%
7/132 • Number of events 8 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
|
Nervous system disorders
Neurological symptom
|
10.4%
27/260 • Number of events 31 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
4.5%
6/132 • Number of events 6 • Adverse events were recorded throughout the study (BL-Wk104) whether serious or not. Members of research team asked participants about AEs at each study visit and recorded these on AE/SAE logs and reported SAEs as per sponsor and regulatory requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place