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
2 other identifiers
interventional
196
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2018
CompletedStudy Start
First participant enrolled
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 5, 2019
CompletedResults Posted
Study results publicly available
January 7, 2020
CompletedJanuary 7, 2020
December 1, 2019
9 months
June 22, 2018
December 19, 2019
December 19, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Change From Baseline in Body Weight at Week 12
Baseline, Week 12
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
Week 12
Study Arms (4)
JNJ-64565111 Dose Level 1
EXPERIMENTALParticipants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
JNJ-64565111 Dose Level 2
EXPERIMENTALParticipants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
JNJ-64565111 Dose Level 3
EXPERIMENTALParticipants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
Interventions
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
National Research Institute
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2018
First Posted
July 16, 2018
Study Start
June 26, 2018
Primary Completion
April 5, 2019
Study Completion
April 5, 2019
Last Updated
January 7, 2020
Results First Posted
January 7, 2020
Record last verified: 2019-12