drugset / Trial / NCT03486392

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

NCT03486392 ↗

Phase 2 Completed 474 enrolled Janssen Research & Development, LLC
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

EvaluationDrugModalityDoseRoute
Subject Efinopegdutide Protein / enzyme biologic — Subcutaneous
Comparator Liraglutide Peptide 3 mg Subcutaneous

Indications