A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Primary Purpose
Obesity and Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JNJ-64565111 Dose Level 1
JNJ-64565111 Dose Level 2
JNJ-64565111 Dose Level 3
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Obesity and Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- Central Research Associates, Inc.
- National Research Institute
- Rancho Cucamonga Clinical Trials
- Sierra Clinical Research
- Encompass Clinical Research
- Diablo Clinical Research, Inc.
- Premeir Clinical Research Institute
- International Research Associates, LLC
- CNS HealthCare
- Translational Research Institute for Metabolism and Diabetes
- Buynak Clinical Research
- Cotton-O'Neil Clinical Research Center
- M.D. Medical Research
- AAMRC
- Alas Science Clinical Research
- Prestige Clinical Research
- Albert J. Weisbrot and Associates
- Clinical Research Institute of Southern Oregon, P.C.
- Clinical Research Associates of Central PA, LLC
- Heritage Valley Medical Group
- Clinical Research Associates Inc
- Dallas Diabetes & Endocrine Center at Medical City
- Baylor Endocrine Center
- Permian Research Foundation
- Spectrum Medical, Inc
- Dominion Medical Associates, Inc.
- National Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
JNJ-64565111 Dose Level 1
JNJ-64565111 Dose Level 2
JNJ-64565111 Dose Level 3
Placebo
Arm Description
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Change From Baseline in Body Weight at Week 12
Change from baseline in body weight at Week 12 was reported.
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.
Full Information
NCT ID
NCT03586830
First Posted
June 22, 2018
Last Updated
December 19, 2019
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03586830
Brief Title
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
April 5, 2019 (Actual)
Study Completion Date
April 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity and Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-64565111 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
Arm Title
JNJ-64565111 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
Arm Title
JNJ-64565111 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
Intervention Type
Drug
Intervention Name(s)
JNJ-64565111 Dose Level 1
Intervention Description
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
Intervention Type
Drug
Intervention Name(s)
JNJ-64565111 Dose Level 2
Intervention Description
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
Intervention Type
Drug
Intervention Name(s)
JNJ-64565111 Dose Level 3
Intervention Description
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Body Weight at Week 12
Description
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Time Frame
Baseline, Week 12
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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. 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.
Time Frame
Up to 16 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight at Week 12
Description
Change from baseline in body weight at Week 12 was reported.
Time Frame
Baseline, Week 12
Title
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
Description
Number of participants with >= 5 % weight loss at Week 12 was reported.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Rancho Cucamonga Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Sierra Clinical Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Premeir Clinical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
CNS HealthCare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Translational Research Institute for Metabolism and Diabetes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Buynak Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Cotton-O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
M.D. Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
AAMRC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Alas Science Clinical Research
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Albert J. Weisbrot and Associates
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, P.C.
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Clinical Research Associates of Central PA, LLC
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Heritage Valley Medical Group
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Clinical Research Associates Inc
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dallas Diabetes & Endocrine Center at Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Permian Research Foundation
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Spectrum Medical, Inc
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Dominion Medical Associates, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
National Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
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