Clinical trial NCT03586830: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity and Diabetes Mellitus, Type 2
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-16
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 16 Weeks
Secondary outcomes:
measure: Change From Baseline in Body Weight at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Trials
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Miami
country: United States
facility: Premeir Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC
state: Florida
city: Orlando
country: United States
facility: CNS HealthCare
state: Florida
city: Orlando
country: United States
facility: Translational Research Institute for Metabolism and Diabetes
state: Florida
city: Valparaiso
country: United States
facility: Buynak Clinical Research
state: Indiana
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Oxon Hill
country: United States
facility: M.D. Medical Research
state: Maryland
city: Flint
country: United States
facility: AAMRC
state: Michigan
city: Henderson
country: United States
facility: Alas Science Clinical Research
state: Nevada
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mason
country: United States
facility: Albert J. Weisbrot and Associates
state: Ohio
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, P.C.
state: Oregon
city: Altoona
country: United States
facility: Clinical Research Associates of Central PA, LLC
state: Pennsylvania
city: Beaver
country: United States
facility: Heritage Valley Medical Group
state: Pennsylvania
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc
state: Virginia
city: Richmond
country: United States
facility: Dominion Medical Associates, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: