A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
Summary
The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.
Timeline
- Start
- 2018-06-26
- Primary completion
- 2019-04-05
- Completion
- 2019-04-05
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs JNJ-64565111 5.0 mg; p <.001; Difference of least square (LS) means -4.56 (95% CI -6.05 to -3.06); Hochberg Approach NCT03586830 ↗
registry analysis (superiority test); Placebo vs JNJ-64565111 7.4 mg; p <.001; Difference of LS Means -5.85 (95% CI -7.34 to -4.36); Hochberg Approach NCT03586830 ↗
registry analysis (superiority test); Placebo vs JNJ-64565111 10.0 mg; p <.001; Difference of LS Means -7.23 (95% CI -8.70 to -5.75); Hochberg Approach NCT03586830 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efinopegdutide | Protein / enzyme biologic | — | Subcutaneous |