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

• Status: Completed
• Trial end date: 2019-03-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Liraglutide

Criteria

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