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A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

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: NCT03586830
Recruitment Status : Completed
First Posted : July 16, 2018
Results First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity and Diabetes Mellitus, Type 2 Drug: JNJ-64565111 Dose Level 1 Drug: JNJ-64565111 Dose Level 2 Drug: JNJ-64565111 Dose Level 3 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
 Drug: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
Experimental: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
 Drug: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
Experimental: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
 Drug: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
Placebo Comparator: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
 Drug: Placebo
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline, Week 12 ]
    Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 16 Weeks ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Body Weight at Week 12 [ Time Frame: Baseline, Week 12 ]
    Change from baseline in body weight at Week 12 was reported.

  2. Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12 [ Time Frame: Week 12 ]
    Number of participants with >= 5 % weight loss at Week 12 was reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=) 50 kilogram per meter square (kg/m^2) at screening
  • Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical or participant reported history)
  • Hemoglobin A1c of >= 6.5% and <= 9.5% at screening and meets one of the inclusion criteria as: (a) on diet and exercise alone >= 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs for >= 12 weeks prior to screening
  • Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
  • Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

  • History of obesity with a known secondary cause (example, Cushing's disease/syndrome)
  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Fasting C-peptide less than (<) 0.7 nanogram per milliliter (ng/mL) at screening
  • Fasting fingerstick glucose of >= 270 milligram per deciliter (mg/dL) (>=15 millimoles per liter [mmol/L]) on Day 1
  • Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. Participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586830


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] August 23, 2018
Statistical Analysis Plan  [PDF] April 19, 2019

More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03586830    
Other Study ID Numbers: CR108488
64565111OBE2002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 16, 2018    Key Record Dates
Results First Posted: January 7, 2020
Last Update Posted: January 7, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases