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

NCT03486392 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and effectiveness of the drug JNJ-64565111 in reducing body weight over 26 weeks in adults who are severely obese but do not have diabetes.

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 474 people

Who can join Ages 18–70 · all sexes

Timeline Started 2018-03 · est. completion 2019-03

Where 51 sites · Belgium, Canada, Poland, Sweden, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT03486392 ↗

Description as written by the study sponsor.

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.

Treatments tested

JNJ-64565111 Dose Level 1 Drug

Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
JNJ-64565111 Dose Level 2 Drug

Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
JNJ-64565111 Dose Level 3 Drug

Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
Liraglutide also known as Saxenda Drug

Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
Placebo Drug

Participants will receive matching placebo SC once-weekly until Week 26.

Main thing measured	Percent Change From Baseline in Body Weight at Week 26
Sponsor	Janssen Research & Development, LLC
Conditions studied	Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03486392 ↗