NCT03586830

A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 196 (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 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.

Conditions

• Obesity and Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	JNJ-64565111 Dose Level 1	Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
DRUG	JNJ-64565111 Dose Level 2	Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
DRUG	JNJ-64565111 Dose Level 3	Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
DRUG	Placebo	Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.

Timeline

• Start date: 2018-06-26
• Primary completion: 2019-04-05
• Completion: 2019-04-05
• First posted: 2018-07-16
• Last updated: 2020-01-07
• Results posted: 2020-01-07

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study