MedTrace Logo

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

NCT03486392 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 474

Last updated 2020-02-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

JNJ-64565111 Dose Level 1

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

DRUG

JNJ-64565111 Dose Level 2

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

DRUG

JNJ-64565111 Dose Level 3

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

DRUG

Liraglutide

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-26
Primary Completion
2019-03-08
Completion
2019-03-08
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Poland
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486392 on ClinicalTrials.gov