CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 196 enrolled
Drug / intervention
JNJ-64565111 Dose Level 1 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03586830
NCT03586830Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Jul 16, 2018·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating JNJ-64565111 Dose Level 1, JNJ-64565111 Dose Level 2, and 2 other interventions for Obesity and Diabetes Mellitus, Type 2. Completed, enrolled 196 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity and Diabetes Mellitus, Type 2
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 16, 2018
Enrollment StartJun 26, 2018
Primary CompletionApr 5, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.0 years ago

Interventions

JNJ-64565111 Dose Level 1drug

Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.

JNJ-64565111 Dose Level 2drug

Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.

JNJ-64565111 Dose Level 3drug

Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.

Placebodrug

Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.