Trials / Completed
CompletedNCT03486392
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 474 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2019-03-08
- Completion
- 2019-03-08
- First posted
- 2018-04-03
- Last updated
- 2020-02-05
- Results posted
- 2020-02-05
Locations
51 sites across 6 countries: United States, Belgium, Canada, Poland, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03486392. Inclusion in this directory is not an endorsement.