Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants (NCT NCT03486392)

NCT ID: NCT03486392

Last Updated: 2020-02-05

Results Overview

Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

474 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2020-02-05

Participant Flow

A total of 474 participants were randomized out of which 444 participants completed the study.

Participant milestones

Participant milestones
Measure	Double Blind: Placebo Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Overall Study STARTED	60	59	118	118	119
Overall Study COMPLETED	57	59	104	109	115
Overall Study NOT COMPLETED	3	0	14	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Double Blind: Placebo Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Overall Study Lost to Follow-up	0	8	5	2
Overall Study Withdrawal by Subject	3	6	4	1
Overall Study Death	0	0	0	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=118 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=118 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=119 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.	Total n=474 Participants Total of all reporting groups
Age, Continuous	46.9 years STANDARD_DEVIATION 11.84 • n=93 Participants	47.3 years STANDARD_DEVIATION 11.18 • n=4 Participants	46.2 years STANDARD_DEVIATION 11.68 • n=27 Participants	46.2 years STANDARD_DEVIATION 12.16 • n=483 Participants	45.6 years STANDARD_DEVIATION 11.71 • n=36 Participants	46.3 years STANDARD_DEVIATION 11.73 • n=10 Participants
Sex: Female, Male Female	48 Participants n=93 Participants	47 Participants n=4 Participants	86 Participants n=27 Participants	86 Participants n=483 Participants	89 Participants n=36 Participants	356 Participants n=10 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	12 Participants n=4 Participants	32 Participants n=27 Participants	32 Participants n=483 Participants	30 Participants n=36 Participants	118 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants	11 Participants n=483 Participants	14 Participants n=36 Participants	42 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=93 Participants	54 Participants n=4 Participants	108 Participants n=27 Participants	107 Participants n=483 Participants	105 Participants n=36 Participants	431 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	3 Participants n=36 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	3 Participants n=483 Participants	1 Participants n=36 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants	8 Participants n=483 Participants	7 Participants n=36 Participants	34 Participants n=10 Participants
Race (NIH/OMB) White	51 Participants n=93 Participants	56 Participants n=4 Participants	106 Participants n=27 Participants	103 Participants n=483 Participants	105 Participants n=36 Participants	421 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	5 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	3 Participants n=10 Participants
Region of Enrollment BELGIUM	7 Participants n=93 Participants	5 Participants n=4 Participants	15 Participants n=27 Participants	13 Participants n=483 Participants	18 Participants n=36 Participants	58 Participants n=10 Participants
Region of Enrollment CANADA	9 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants	17 Participants n=483 Participants	16 Participants n=36 Participants	62 Participants n=10 Participants
Region of Enrollment POLAND	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants	18 Participants n=483 Participants	15 Participants n=36 Participants	61 Participants n=10 Participants
Region of Enrollment SWEDEN	12 Participants n=93 Participants	14 Participants n=4 Participants	22 Participants n=27 Participants	19 Participants n=483 Participants	14 Participants n=36 Participants	81 Participants n=10 Participants
Region of Enrollment UNITED KINGDOM	5 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants	11 Participants n=483 Participants	17 Participants n=36 Participants	58 Participants n=10 Participants
Region of Enrollment UNITED STATES	19 Participants n=93 Participants	18 Participants n=4 Participants	38 Participants n=27 Participants	40 Participants n=483 Participants	39 Participants n=36 Participants	154 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Modified intent-to-treat (mITT) population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.

Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.

Outcome measures

Outcome measures
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=58 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=109 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=109 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=108 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Percent Change From Baseline in Body Weight at Week 26	-1.76 Percent Change Standard Error 0.73	-8.51 Percent Change Standard Error 0.76	-9.83 Percent Change Standard Error 0.56	-11.80 Percent Change Standard Error 0.58	-7.54 Percent Change Standard Error 0.54

PRIMARY outcome

Timeframe: Up to Week 30

Population: Safety analysis set included 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. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.

Outcome measures

Outcome measures
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=118 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=118 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=119 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	43 Participants	53 Participants	110 Participants	110 Participants	96 Participants

SECONDARY outcome

Timeframe: Week 26

Population: mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.

Number of participants with \>= 5% body weight loss from baseline to Week 26 were reported.

Outcome measures

Outcome measures
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=116 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=116 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=109 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26	8 Participants	34 Participants	70 Participants	62 Participants	56 Participants

SECONDARY outcome

Timeframe: Week 26

Number of participants with \>= 10 % body weight loss from baseline to Week 26 were reported.

Outcome measures

Outcome measures
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=116 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=116 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=109 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26	2 Participants	23 Participants	43 Participants	46 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Change from baseline in body weight at Week 26 was reported.

Outcome measures

Outcome measures
Measure	Double Blind: Placebo n=60 Participants Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=58 Participants Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=109 Participants Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=109 Participants Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=108 Participants Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Change From Baseline in Body Weight at Week 26	-2.05 kg Standard Error 0.827	-9.58 kg Standard Error 0.861	-11.07 kg Standard Error 0.633	-13.23 kg Standard Error 0.656	-8.32 kg Standard Error 0.610

Adverse Events

Double Blind: Placebo

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Double Blind: JNJ-64565111 5.0 mg

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Double Blind: JNJ-64565111 7.4 mg

Serious events: 2 serious events

Other events: 106 other events

Deaths: 0 deaths

Double Blind: JNJ-64565111 10.0 mg

Serious events: 4 serious events

Other events: 104 other events

Deaths: 0 deaths

Open Label: Liraglutide 3.0 mg

Serious events: 4 serious events

Other events: 81 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Double Blind: Placebo n=60 participants at risk Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 participants at risk Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=118 participants at risk Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=118 participants at risk Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=119 participants at risk Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Cardiac disorders Myocardial Infarction	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Cardiac disorders Stress Cardiomyopathy	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 1/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Umbilical Hernia	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Hepatobiliary disorders Biliary Colic	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 1/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 1/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Psychiatric disorders Major Depression	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Reproductive system and breast disorders Menorrhagia	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Double Blind: Placebo n=60 participants at risk Participants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 5.0 mg n=59 participants at risk Participants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 7.4 mg n=118 participants at risk Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Double Blind: JNJ-64565111 10.0 mg n=118 participants at risk Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.	Open Label: Liraglutide 3.0 mg n=119 participants at risk Participant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.
Gastrointestinal disorders Abdominal Discomfort	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 3/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal Distension	3.3% 2/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 4/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 6/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 6/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.9% 7/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal Pain	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	3.4% 2/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 8/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	3.4% 4/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Abdominal Pain Upper	3.3% 2/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	3.4% 2/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.5% 10/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.7% 8/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Constipation	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.9% 7/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.9% 20/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	17.8% 21/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.8% 20/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	13.6% 8/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	20.3% 24/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	19.5% 23/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	22.7% 27/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Dry Mouth	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 4/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 6/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	4.2% 5/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	3.3% 2/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.5% 5/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	15.3% 18/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.0% 13/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	7.6% 9/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Eructation	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 4/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.9% 14/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	13.6% 16/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	4.2% 5/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.5% 5/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.0% 13/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	10.2% 12/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	7.6% 9/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Nausea	6.7% 4/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	50.8% 30/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	67.8% 80/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	66.9% 79/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	40.3% 48/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	20.3% 12/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	39.8% 47/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	54.2% 64/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.8% 20/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
General disorders Fatigue	3.3% 2/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.9% 7/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	12.7% 15/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	14.4% 17/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	4.2% 5/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
General disorders Injection Site Bruising	6.7% 4/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	3.4% 2/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Gastroenteritis	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 1/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.85% 1/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.84% 1/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Nasopharyngitis	15.0% 9/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.5% 5/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	9.3% 11/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 6/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.4% 10/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Pharyngitis	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Upper Respiratory Tract Infection	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	3.4% 4/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.0% 6/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Infections and infestations Urinary Tract Infection	5.0% 3/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 4/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.5% 10/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.9% 7/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	4.2% 5/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Investigations Hepatic Enzyme Increased	0.00% 0/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	5.1% 6/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Metabolism and nutrition disorders Decreased Appetite	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.9% 10/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	13.6% 16/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.9% 20/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	8.4% 10/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Nervous system disorders Dysgeusia	1.7% 1/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 4/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	2.5% 3/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	1.7% 2/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	0.00% 0/119 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.
Nervous system disorders Headache	10.0% 6/60 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	11.9% 7/59 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	16.9% 20/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	6.8% 8/118 • Up to 30 Weeks Safety analysis set included all randomized participants who had received at least one dose of study drug.	7.6% 9/119 • Up to 30 Weeks Safety analysis set included 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