A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

Description

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.

Study Start Date

March, 26 2018

Estimated Completion Date

March 2019

Interventions

  • Drug: JNJ-64565111 Dose Level 2
  • Drug: JNJ-64565111 Dose Level 3
  • Drug: Liraglutide
  • Drug: Placebo
  • Drug: JNJ-64565111 Dose Level 1

Study ID

Janssen Research & Development, LLC -- CR108314

Status

Unknown

Trial ID

NCT03486392

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

440

Sponsor

Janssen Research & Development, LLC

Inclusion Criteria

  • Body mass index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=) 50 kilogram per square meter (kg/m^2) at the screening visit
  • Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical 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
  • Woman of childbearing potential have a negative pregnancy test at screening
  • Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria

  • History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
  • History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
  • Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
  • History of glucagonoma

Gender

All

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (16)

Study Location Distance Name Phone Email
Weill Cornell Medicine - New York, New York 50.7 miles None None None
Omega Medical Research - Warwick, Rhode Island 99.7 miles None None None
Milford Emergency Associates Inc - Marlborough, Massachusetts 117.6 miles None None None
Central New York Clinical Research - Manlius, New York 186.1 miles None None None
Rapid Medical Research - Cleveland, Ohio 430.0 miles None None None
Coastal Carolina Research Center - Mount Pleasant, South Carolina 686.1 miles None None None
LMarc Research Center - Louisville, Kentucky 696.0 miles None None None
Allegiance Reserach Specialists LLC - Wauwatosa, Wisconsin 769.3 miles None None None
Medisphere Medical Research Center Llc - Evansville, Indiana 793.5 miles None None None
Care Partners Clinical Research - Jacksonville, Florida 884.9 miles None None None
Dallas Diabetes Research Center - Dallas, Texas 1,417.3 miles None None None
Permian Research Foundation - Odessa, Texas 1,734.6 miles None None None
Central Phoenix Medical Clinic - Phoenix, Arizona 2,181.4 miles None None None
Advanced Clinical Research - Boise, Idaho 2,188.1 miles None None None
Rainier Clinical Research Center - Renton, Washington 2,421.8 miles None None None
Diablo Clinical Research Inc - Walnut Creek, California 2,580.4 miles None None None

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