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| ID | Type | Description | Link |
|---|---|---|---|
| 64565111OBE2002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-64565111 Dose Level 1 | Experimental | Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase. |
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| JNJ-64565111 Dose Level 2 | Experimental | Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase. |
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| JNJ-64565111 Dose Level 3 | Experimental | Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase. |
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| Placebo | Placebo Comparator | Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64565111 Dose Level 1 | Drug | Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 12 | Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported. | Baseline, Week 12 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | Up to 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight at Week 12 was reported. | Baseline, Week 12 |
| Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates, Inc. | Birmingham | Alabama | 35205 | United States | ||
| National Research Institute |
Total 196 participants were randomized out of which 175 participants completed study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | JNJ-64565111 5.0 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2018 | Dec 19, 2019 |
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| JNJ-64565111 Dose Level 2 | Drug | Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12. |
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| JNJ-64565111 Dose Level 3 | Drug | Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12. |
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| Placebo | Drug | Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12. |
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Number of participants with >= 5 % weight loss at Week 12 was reported.
| Week 12 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Rancho Cucamonga Clinical Trials | Rancho Cucamonga | California | 91730 | United States |
| Sierra Clinical Research | Roseville | California | 95661 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Premeir Clinical Research Institute | Miami | Florida | 33122 | United States |
| International Research Associates, LLC | Miami | Florida | 33183 | United States |
| CNS HealthCare | Orlando | Florida | 32801 | United States |
| Translational Research Institute for Metabolism and Diabetes | Orlando | Florida | 32804 | United States |
| Buynak Clinical Research | Valparaiso | Indiana | 46383 | United States |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| M.D. Medical Research | Oxon Hill | Maryland | 20745 | United States |
| AAMRC | Flint | Michigan | 48504 | United States |
| Alas Science Clinical Research | Henderson | Nevada | 89014 | United States |
| Prestige Clinical Research | Franklin | Ohio | 45005 | United States |
| Albert J. Weisbrot and Associates | Mason | Ohio | 45040 | United States |
| Clinical Research Institute of Southern Oregon, P.C. | Medford | Oregon | 97504 | United States |
| Clinical Research Associates of Central PA, LLC | Altoona | Pennsylvania | 16602 | United States |
| Heritage Valley Medical Group | Beaver | Pennsylvania | 15009 | United States |
| Clinical Research Associates Inc | Nashville | Tennessee | 37203 | United States |
| Dallas Diabetes & Endocrine Center at Medical City | Dallas | Texas | 75230 | United States |
| Baylor Endocrine Center | Dallas | Texas | 75246 | United States |
| Permian Research Foundation | Odessa | Texas | 79761 | United States |
| Spectrum Medical, Inc | Danville | Virginia | 24541 | United States |
| Dominion Medical Associates, Inc. | Richmond | Virginia | 23219 | United States |
| National Clinical Research | Richmond | Virginia | 23294 | United States |
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.
| FG002 | 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. |
| FG003 | 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. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all randomized participants who had received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Body Weight at Week 12 | Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported. | 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. | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline, Week 12 |
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| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. | Safety analysis set included include all randomized participants who had received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 16 Weeks |
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| Secondary | Change From Baseline in Body Weight at Week 12 | Change from baseline in body weight at Week 12 was reported. | 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. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 12 |
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| Secondary | Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 | Number of participants with >= 5 % weight loss at Week 12 was reported. | 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. | Posted | Count of Participants | Participants | Week 12 |
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Up to 16 Weeks
Safety analysis set included include all randomized participants who had received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 49 | 1 | 49 | 18 | 49 |
| EG001 | 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. | 0 | 48 | 2 | 48 | 25 | 48 |
| EG002 | 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. | 0 | 49 | 1 | 49 | 33 | 49 |
| EG003 | 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. | 0 | 49 | 3 | 49 | 30 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Gastroenteritis Viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Incarcerated Incisional Hernia | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
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| Amylase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Lipase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Pancreatic Enzymes Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Leader | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2019 | Dec 19, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| <.001 |
| Difference of LS Means |
| -5.85 |
| Standard Error of the Mean |
| 0.755 |
| 2-Sided |
| 95 |
| -7.34 |
| -4.36 |
| Superiority |
| Hochberg Approach | <.001 | Difference of LS Means | -7.23 | Standard Error of the Mean | 0.748 | 2-Sided | 95 | -8.70 | -5.75 | Superiority |
| OG002 |
| 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. |
| OG003 | 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. |
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Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug. |
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Participants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 12-week treatment phase or until early discontinuation of study drug. |
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