Trial Outcomes & Findings for Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity (NCT NCT02496611)
NCT ID: NCT02496611
Last Updated: 2022-01-03
Results Overview
Percentage of body mass index change from Randomization to Week 52
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
52 weeks
Results posted on
2022-01-03
Participant Flow
100 participants consented to enroll in the study and entered the screening phase. During the screening phase participants entered and 8-week meal replacement therapy phase to help them meet a goal of achieving reducing their body mass by 5% or more. Only those participants who met this weight loss goal passed the study screening and were allowed to be randomized to receive placebo or GLP-1 RA. 66 participants met the BMI weight loss goal, 34 participants did not pass the screening phase.
Only individuals who achieve the \>/= 5% BMI reduction will be considered to have passed screening and will be allowed to be randomized to treatment with GLP-1 RA or placebo.
Participant milestones
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and placebo.
|
Weight Loss Maintenance With Pharmacotherapy
A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and pharmacotherapy with Exenatide extended-release.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and placebo.
|
Weight Loss Maintenance With Pharmacotherapy
A total of 33 participants who met the initial weight loss goal during the meal replacement induction were randomized to receive lifestyle therapy and pharmacotherapy with Exenatide extended-release.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity
Baseline characteristics by cohort
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
n=33 Participants
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trail.
Meal Replacement Therapy: A short-term meal replacement induction period designed to achieve \>5% BMI reduction in 1, 2, or 3 months.
|
Weight Loss Maintenance With Pharmacotherapy
n=33 Participants
We hypothesize that adolescents with severe obesity receiving GLP-1RA treatment following a short-term meal replacement induction period will demonstrate superior maintenance of initial BMI reduction 52 weeks following randomization compared to those assigned to placebo (primary endpoint) and that a higher proportion of those assigned to GLP-1RA treatment vs. placebo will maintain ≥5% BMI reduction from baseline to the 52-week time point (secondary endpoint)
Exenatide extended-release for injectable suspension (BYDUREON™)
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Change in body mass index (percentage) from Randomization to Week 52.
Percentage of body mass index change from Randomization to Week 52
Outcome measures
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
n=33 Participants
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle management therapy with placebo.
|
Weight Loss Maintenance With Pharmacotherapy
n=33 Participants
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle management therapy with pharmacotherapy treatment with Exenatide extended-release.
|
|---|---|---|
|
Body Mass Index
|
10.1 percentage (body mass index)
Standard Deviation 9.0
|
4.6 percentage (body mass index)
Standard Deviation 10.5
|
Adverse Events
Weight Loss Maintenance Without Pharmacotherapy
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Weight Loss Maintenance With Pharmacotherapy
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Meal Replacement Induction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
n=33 participants at risk
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle maintenance therapy without pharmacotherapy.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
Weight Loss Maintenance With Pharmacotherapy
n=33 participants at risk
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle maintenance therapy with pharmacotherapy.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
Meal Replacement Induction
n=100 participants at risk
A short-term (1-3 month) meal replacement induction period to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
All individuals were enrolled into this group upon signing consent and determining eligibility.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hospitalization for chemical dependency
|
0.00%
0/33 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
3.0%
1/33 • Number of events 1 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
Other adverse events
| Measure |
Weight Loss Maintenance Without Pharmacotherapy
n=33 participants at risk
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle maintenance therapy without pharmacotherapy.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
Weight Loss Maintenance With Pharmacotherapy
n=33 participants at risk
A short-term (1-3 month) meal replacement induction period design to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
Individuals in this group were randomized to receive lifestyle maintenance therapy with pharmacotherapy.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
Meal Replacement Induction
n=100 participants at risk
A short-term (1-3 month) meal replacement induction period to achieve ≥5% BMI reduction. If participants achieve ≥5% BMI they will be randomized to drug or placebo in phase 2 of the trial.
All individuals were enrolled into this group upon signing consent and determining eligibility.
Serious Adverse Events and Adverse Events were not reported during the meal replacement induction.
|
|---|---|---|---|
|
General disorders
Headache
|
42.4%
14/33 • Number of events 17 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
57.6%
19/33 • Number of events 20 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
72.7%
24/33 • Number of events 29 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
78.8%
26/33 • Number of events 32 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
39.4%
13/33 • Number of events 16 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
21.2%
7/33 • Number of events 7 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Gastrointestinal disorders
Nausea
|
21.2%
7/33 • Number of events 7 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
39.4%
13/33 • Number of events 15 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
General disorders
Vomiting
|
6.1%
2/33 • Number of events 3 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
39.4%
13/33 • Number of events 15 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Hepatobiliary disorders
Diarrhea
|
18.2%
6/33 • Number of events 6 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
33.3%
11/33 • Number of events 14 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Hepatobiliary disorders
Constipation
|
18.2%
6/33 • Number of events 9 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
18.2%
6/33 • Number of events 6 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.1%
4/33 • Number of events 5 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
15.2%
5/33 • Number of events 5 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
3/33 • Number of events 3 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
9.1%
3/33 • Number of events 4 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Nervous system disorders
Dizziness
|
9.1%
3/33 • Number of events 3 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
12.1%
4/33 • Number of events 4 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
|
Immune system disorders
Flu-like symptoms
|
12.1%
4/33 • Number of events 4 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
9.1%
3/33 • Number of events 3 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
0.00%
0/100 • Adverse event and serious adverse event data was collected from Baseline to Week 52.
The adverse events and serious adverse events that are reported are for those participants who met the minimum 5% BMI loss goal and were eligible to be randomized to receive either the placebo or GLP-1 RA.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place