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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: JNJ-64565111 Dose Level 1; Drug: JNJ-64565111 Dose Level 2; Drug: JNJ-64565111 Dose Level 3; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
  • California
    • Los Angeles, California, United States, 90057
      • National Research Institute
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Trials
    • Roseville, California, United States, 95661
      • Sierra Clinical Research
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Miami, Florida, United States, 33122
      • Premeir Clinical Research Institute
    • Orlando, Florida, United States, 32804
      • Translational Research Institute for Metabolism and Diabetes
    • Orlando, Florida, United States, 32801
      • CNS Healthcare
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Buynak Clinical Research
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • M.D. Medical Research
  • Michigan
    • Flint, Michigan, United States, 48504
      • AAMRC
  • Nevada
    • Henderson, Nevada, United States, 89014
      • ALAS Science Clinical Research
  • Ohio
    • Franklin, Ohio, United States, 45005
      • Prestige Clinical Research
    • Mason, Ohio, United States, 45040
      • Albert J. Weisbrot and Associates
  • Oregon
    • Medford, Oregon, United States, 97504
      • Clinical Research Institute of Southern Oregon, P.C.
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Clinical Research Associates of Central Pa, LLC
    • Beaver, Pennsylvania, United States, 15009
      • Heritage Valley Medical Group
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Inc
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Endocrine Center
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes & Endocrine Center at Medical City
    • Odessa, Texas, United States, 79761
      • Permian Research Foundation
  • Virginia
    • Danville, Virginia, United States, 24541
      • Spectrum Medical, Inc
    • Richmond, Virginia, United States, 23294
      • National Clinical Research
    • Richmond, Virginia, United States, 23219
      • Dominion Medical Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Number of participants with >= 5 % weight loss at Week 12 was reported.	Week 12

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2018
• Primary Completion (ACTUAL): April 5, 2019
• Study Completion (ACTUAL): April 5, 2019

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (ACTUAL): July 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CR108488; 64565111OBE2002 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No