At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects
In Brief
A Phase 2 clinical trial evaluating JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2, and 3 other interventions for Obesity. Completed, enrolled 474 participants across 51 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
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.
Participants will receive matching placebo SC once-weekly until Week 26.