Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus (NCT NCT03586830)
NCT ID: NCT03586830
Last Updated: 2020-01-07
Results Overview
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
196 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2020-01-07
Participant Flow
Total 196 participants were randomized out of which 175 participants completed study.
Participant milestones
| Measure |
Placebo
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
49
|
49
|
|
Overall Study
Treated
|
49
|
48
|
49
|
49
|
|
Overall Study
COMPLETED
|
48
|
42
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Overall Study
Site terminated by Sponsor
|
1
|
4
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
1
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Placebo
n=49 Participants
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=48 Participants
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=49 Participants
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=49 Participants
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 9.09 • n=39 Participants
|
55.1 years
STANDARD_DEVIATION 9.56 • n=41 Participants
|
57.8 years
STANDARD_DEVIATION 8.97 • n=35 Participants
|
56.2 years
STANDARD_DEVIATION 8.57 • n=31 Participants
|
56.6 years
STANDARD_DEVIATION 9.04 • n=146 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
118 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
21 Participants
n=31 Participants
|
77 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
51 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
34 Participants
n=31 Participants
|
144 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
52 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
31 Participants
n=31 Participants
|
139 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
UNITED STATES
|
49 Participants
n=39 Participants
|
48 Participants
n=41 Participants
|
49 Participants
n=35 Participants
|
49 Participants
n=31 Participants
|
195 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Modified intent-to-treat (mITT) analysis set included all intent-to-treat (ITT) participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=45 Participants
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=46 Participants
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=47 Participants
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 12
|
-0.70 Percent Change
Standard Error 0.50
|
-5.25 Percent Change
Standard Error 0.57
|
-6.55 Percent Change
Standard Error 0.56
|
-7.92 Percent Change
Standard Error 0.55
|
PRIMARY outcome
Timeframe: Up to 16 WeeksPopulation: Safety analysis set included include all randomized participants who had received at least one dose of study drug.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=48 Participants
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=49 Participants
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=49 Participants
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
28 Participants
|
30 Participants
|
39 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Change from baseline in body weight at Week 12 was reported.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=45 Participants
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=46 Participants
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=47 Participants
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 12
|
-0.90 kg
Standard Error 0.577
|
-5.92 kg
Standard Error 0.653
|
-7.34 kg
Standard Error 0.648
|
-9.04 kg
Standard Error 0.635
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis set included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement.
Number of participants with \>= 5 % weight loss at Week 12 was reported.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=47 Participants
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=48 Participants
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=48 Participants
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
|
1 Participants
|
20 Participants
|
20 Participants
|
30 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
JNJ-64565111 5.0 mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
JNJ-64565111 7.4 mg
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
JNJ-64565111 10.0 mg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=49 participants at risk
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=48 participants at risk
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=49 participants at risk
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=49 participants at risk
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Incarcerated Incisional Hernia
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.1%
1/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.1%
1/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=49 participants at risk
Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 5.0 mg
n=48 participants at risk
Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 7.4 mg
n=49 participants at risk
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
JNJ-64565111 10.0 mg
n=49 participants at risk
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.2%
2/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.2%
4/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.3%
4/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
18.4%
9/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.2%
4/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.2%
3/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
12.2%
6/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.2%
3/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.2%
5/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
27.1%
13/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
34.7%
17/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
42.9%
21/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
16.7%
8/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
24.5%
12/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
34.7%
17/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
General disorders
Fatigue
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.1%
1/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.2%
4/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.1%
1/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.2%
3/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.0%
1/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.2%
3/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Investigations
Amylase Increased
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.2%
2/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
10.2%
5/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Investigations
Lipase Increased
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
4.2%
2/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
12.2%
6/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Investigations
Pancreatic Enzymes Increased
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
2.1%
1/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.2%
4/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
4.1%
2/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
10.4%
5/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
14.3%
7/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
14.3%
7/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.1%
3/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/48 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
8.2%
4/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
0.00%
0/49 • Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
|
Additional Information
Senior Director Clinical Leader
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER