drugset / Trial / NCT03486392
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2018-03-26
- Primary completion
- 2019-03-08
- Completion
- 2019-03-08
Outcome
Met primary endpoint
registry analysis (superiority test); Double Blind: Placebo vs Double Blind: JNJ-64565111 5.0 mg; p < 0.001; Difference of least square (LS) Means -6.75 (95% CI -9.31 to -4.19); Dunnett's method NCT03486392 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efinopegdutide | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Liraglutide | Peptide | 3 mg | Subcutaneous |