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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486392
Recruitment Status : Completed
First Posted : April 3, 2018
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: JNJ-64565111 Dose Level 1
Drug: JNJ-64565111 Dose Level 2
Drug: JNJ-64565111 Dose Level 3
Drug: Liraglutide
Drug: Placebo
Enrollment 474
Recruitment Details  
Pre-assignment Details A total of 474 participants were randomized out of which 444 participants completed the study.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description 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. 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. Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. 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.
Period Title: Overall Study
Started 60 59 118 118 119
Completed 57 59 104 109 115
Not Completed 3 0 14 9 4
Reason Not Completed
Lost to Follow-up             0             0             8             5             2
Withdrawal by Subject             3             0             6             4             1
Death             0             0             0             0             1
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg Total
Hide Arm/Group Description 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. 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. Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. 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 of all reporting groups
Overall Number of Baseline Participants 60 59 118 118 119 474
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 59 participants 118 participants 118 participants 119 participants 474 participants
46.9  (11.84) 47.3  (11.18) 46.2  (11.68) 46.2  (12.16) 45.6  (11.71) 46.3  (11.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 118 participants 118 participants 119 participants 474 participants
Female
48
  80.0%
47
  79.7%
86
  72.9%
86
  72.9%
89
  74.8%
356
  75.1%
Male
12
  20.0%
12
  20.3%
32
  27.1%
32
  27.1%
30
  25.2%
118
  24.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 118 participants 118 participants 119 participants 474 participants
Hispanic or Latino
3
   5.0%
5
   8.5%
9
   7.6%
11
   9.3%
14
  11.8%
42
   8.9%
Not Hispanic or Latino
57
  95.0%
54
  91.5%
108
  91.5%
107
  90.7%
105
  88.2%
431
  90.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
1
   0.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 118 participants 118 participants 119 participants 474 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.2%
Asian
1
   1.7%
0
   0.0%
1
   0.8%
1
   0.8%
3
   2.5%
6
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
3
   2.5%
1
   0.8%
4
   0.8%
Black or African American
8
  13.3%
3
   5.1%
8
   6.8%
8
   6.8%
7
   5.9%
34
   7.2%
White
51
  85.0%
56
  94.9%
106
  89.8%
103
  87.3%
105
  88.2%
421
  88.8%
More than one race
0
   0.0%
0
   0.0%
2
   1.7%
2
   1.7%
1
   0.8%
5
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.8%
1
   0.8%
3
   0.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 118 participants 118 participants 119 participants 474 participants
BELGIUM
7
  11.7%
5
   8.5%
15
  12.7%
13
  11.0%
18
  15.1%
58
  12.2%
CANADA
9
  15.0%
8
  13.6%
12
  10.2%
17
  14.4%
16
  13.4%
62
  13.1%
POLAND
8
  13.3%
6
  10.2%
14
  11.9%
18
  15.3%
15
  12.6%
61
  12.9%
SWEDEN
12
  20.0%
14
  23.7%
22
  18.6%
19
  16.1%
14
  11.8%
81
  17.1%
UNITED KINGDOM
5
   8.3%
8
  13.6%
17
  14.4%
11
   9.3%
17
  14.3%
58
  12.2%
UNITED STATES
19
  31.7%
18
  30.5%
38
  32.2%
40
  33.9%
39
  32.8%
154
  32.5%
1.Primary Outcome
Title Percent Change From Baseline in Body Weight at Week 26
Hide Description Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description:
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.
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.
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
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 Number of Participants Analyzed 60 58 109 109 108
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change
-1.76  (0.73) -8.51  (0.76) -9.83  (0.56) -11.80  (0.58) -7.54  (0.54)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double Blind: Placebo, Double Blind: JNJ-64565111 5.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Dunnett's method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of least square (LS) Means
Estimated Value -6.75
Confidence Interval (2-Sided) 95%
-9.31 to -4.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.056
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double Blind: Placebo, Double Blind: JNJ-64565111 7.4 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Dunnett's method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -8.07
Confidence Interval (2-Sided) 95%
-10.31 to -5.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.921
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double Blind: Placebo, Double Blind: JNJ-64565111 10.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Dunnett's method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -10.04
Confidence Interval (2-Sided) 95%
-12.31 to -7.78
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.934
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Double Blind: Placebo, Open Label: Liraglutide 3.0 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Dunnett's method
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference of LS Means
Estimated Value -5.78
Confidence Interval (2-Sided) 95%
-7.99 to -3.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.910
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame Up to Week 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who had received at least one dose of study drug.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description:
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.
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.
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
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 Number of Participants Analyzed 60 59 118 118 119
Measure Type: Count of Participants
Unit of Measure: Participants
43
  71.7%
53
  89.8%
110
  93.2%
110
  93.2%
96
  80.7%
3.Secondary Outcome
Title Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Hide Description Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description:
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.
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.
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
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 Number of Participants Analyzed 60 59 116 116 109
Measure Type: Count of Participants
Unit of Measure: Participants
8
  13.3%
34
  57.6%
70
  60.3%
62
  53.4%
56
  51.4%
4.Secondary Outcome
Title Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Hide Description Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description:
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.
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.
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
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 Number of Participants Analyzed 60 59 116 116 109
Measure Type: Count of Participants
Unit of Measure: Participants
2
   3.3%
23
  39.0%
43
  37.1%
46
  39.7%
27
  24.8%
5.Secondary Outcome
Title Change From Baseline in Body Weight at Week 26
Hide Description Change from baseline in body weight at Week 26 was reported.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description:
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.
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.
Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.
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 Number of Participants Analyzed 60 58 109 109 108
Least Squares Mean (Standard Error)
Unit of Measure: kg
-2.05  (0.827) -9.58  (0.861) -11.07  (0.633) -13.23  (0.656) -8.32  (0.610)
Time Frame Up to 30 Weeks
Adverse Event Reporting Description Safety analysis set included all randomized participants who had received at least one dose of study drug.
 
Arm/Group Title Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Hide Arm/Group Description 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. 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. Participants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug. 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.
All-Cause Mortality
Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/59 (0.00%)   0/118 (0.00%)   0/118 (0.00%)   1/119 (0.84%) 
Hide Serious Adverse Events
Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/60 (6.67%)   3/59 (5.08%)   2/118 (1.69%)   4/118 (3.39%)   4/119 (3.36%) 
Cardiac disorders           
Myocardial Infarction * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  1/119 (0.84%) 
Stress Cardiomyopathy * 1  0/60 (0.00%)  0/59 (0.00%)  1/118 (0.85%)  0/118 (0.00%)  0/119 (0.00%) 
Gastrointestinal disorders           
Ileus * 1  0/60 (0.00%)  1/59 (1.69%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
Pancreatitis Acute * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  1/119 (0.84%) 
Umbilical Hernia * 1  1/60 (1.67%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
Vomiting * 1  0/60 (0.00%)  0/59 (0.00%)  1/118 (0.85%)  2/118 (1.69%)  0/119 (0.00%) 
Hepatobiliary disorders           
Biliary Colic * 1  0/60 (0.00%)  1/59 (1.69%)  0/118 (0.00%)  0/118 (0.00%)  1/119 (0.84%) 
Cholelithiasis * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  1/119 (0.84%) 
Infections and infestations           
Pneumonia * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  1/118 (0.85%)  0/119 (0.00%) 
Metabolism and nutrition disorders           
Dehydration * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  1/118 (0.85%)  0/119 (0.00%) 
Hyponatraemia * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  1/118 (0.85%)  0/119 (0.00%) 
Obesity * 1  1/60 (1.67%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
Musculoskeletal and connective tissue disorders           
Osteoarthritis * 1  1/60 (1.67%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
Pregnancy, puerperium and perinatal conditions           
Abortion Spontaneous * 1  0/60 (0.00%)  1/59 (1.69%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
Psychiatric disorders           
Major Depression * 1  0/60 (0.00%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  1/119 (0.84%) 
Reproductive system and breast disorders           
Menorrhagia * 1  1/60 (1.67%)  0/59 (0.00%)  0/118 (0.00%)  0/118 (0.00%)  0/119 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double Blind: Placebo Double Blind: JNJ-64565111 5.0 mg Double Blind: JNJ-64565111 7.4 mg Double Blind: JNJ-64565111 10.0 mg Open Label: Liraglutide 3.0 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/60 (55.00%)   43/59 (72.88%)   106/118 (89.83%)   104/118 (88.14%)   81/119 (68.07%) 
Gastrointestinal disorders           
Abdominal Discomfort * 1  1/60 (1.67%)  3/59 (5.08%)  0/118 (0.00%)  3/118 (2.54%)  1/119 (0.84%) 
Abdominal Distension * 1  2/60 (3.33%)  4/59 (6.78%)  6/118 (5.08%)  6/118 (5.08%)  7/119 (5.88%) 
Abdominal Pain * 1  1/60 (1.67%)  2/59 (3.39%)  8/118 (6.78%)  4/118 (3.39%)  3/119 (2.52%) 
Abdominal Pain Upper * 1  2/60 (3.33%)  2/59 (3.39%)  10/118 (8.47%)  3/118 (2.54%)  8/119 (6.72%) 
Constipation * 1  3/60 (5.00%)  7/59 (11.86%)  20/118 (16.95%)  21/118 (17.80%)  20/119 (16.81%) 
Diarrhoea * 1  3/60 (5.00%)  8/59 (13.56%)  24/118 (20.34%)  23/118 (19.49%)  27/119 (22.69%) 
Dry Mouth * 1  1/60 (1.67%)  4/59 (6.78%)  6/118 (5.08%)  5/118 (4.24%)  3/119 (2.52%) 
Dyspepsia * 1  2/60 (3.33%)  5/59 (8.47%)  18/118 (15.25%)  13/118 (11.02%)  9/119 (7.56%) 
Eructation * 1  0/60 (0.00%)  4/59 (6.78%)  14/118 (11.86%)  16/118 (13.56%)  5/119 (4.20%) 
Gastrooesophageal Reflux Disease * 1  1/60 (1.67%)  5/59 (8.47%)  13/118 (11.02%)  12/118 (10.17%)  9/119 (7.56%) 
Nausea * 1  4/60 (6.67%)  30/59 (50.85%)  80/118 (67.80%)  79/118 (66.95%)  48/119 (40.34%) 
Vomiting * 1  0/60 (0.00%)  12/59 (20.34%)  47/118 (39.83%)  64/118 (54.24%)  20/119 (16.81%) 
General disorders           
Fatigue * 1  2/60 (3.33%)  7/59 (11.86%)  15/118 (12.71%)  17/118 (14.41%)  5/119 (4.20%) 
Injection Site Bruising * 1  4/60 (6.67%)  2/59 (3.39%)  1/118 (0.85%)  2/118 (1.69%)  1/119 (0.84%) 
Infections and infestations           
Gastroenteritis * 1  3/60 (5.00%)  1/59 (1.69%)  1/118 (0.85%)  1/118 (0.85%)  1/119 (0.84%) 
Nasopharyngitis * 1  9/60 (15.00%)  5/59 (8.47%)  11/118 (9.32%)  6/118 (5.08%)  10/119 (8.40%) 
Pharyngitis * 1  3/60 (5.00%)  0/59 (0.00%)  2/118 (1.69%)  0/118 (0.00%)  3/119 (2.52%) 
Upper Respiratory Tract Infection * 1  3/60 (5.00%)  0/59 (0.00%)  4/118 (3.39%)  2/118 (1.69%)  6/119 (5.04%) 
Urinary Tract Infection * 1  3/60 (5.00%)  4/59 (6.78%)  10/118 (8.47%)  7/118 (5.93%)  5/119 (4.20%) 
Investigations           
Hepatic Enzyme Increased * 1  0/60 (0.00%)  0/59 (0.00%)  2/118 (1.69%)  6/118 (5.08%)  0/119 (0.00%) 
Metabolism and nutrition disorders           
Decreased Appetite * 1  1/60 (1.67%)  10/59 (16.95%)  16/118 (13.56%)  20/118 (16.95%)  10/119 (8.40%) 
Nervous system disorders           
Dysgeusia * 1  1/60 (1.67%)  4/59 (6.78%)  3/118 (2.54%)  2/118 (1.69%)  0/119 (0.00%) 
Headache * 1  6/60 (10.00%)  7/59 (11.86%)  20/118 (16.95%)  8/118 (6.78%)  9/119 (7.56%) 
1
Term from vocabulary, MedDRA Version 21.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Clinical Leader
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03486392    
Other Study ID Numbers: CR108314
64565111OBE2001 ( Other Identifier: Janssen Research & Development, LLC )
2017-003616-39 ( EudraCT Number )
First Submitted: March 23, 2018
First Posted: April 3, 2018
Results First Submitted: January 14, 2020
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020