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NCT03586830 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Obesity and Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 2
Development phase
196
Enrollment target
20
Study locations

NCT03586830: Completed Phase 2 study of Obesity and Diabetes Mellitus, Type 2, sponsored by Janssen Research & Development.

NCT03586830 is a Phase 2 study of Obesity and Diabetes Mellitus, Type 2 that has completed, run by Janssen Research & Development. The registered enrollment target is 196 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03586830, a Phase 2 study of Obesity and Diabetes Mellitus, Type 2, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 2
Development phase
196 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.

Interventions

  • DRUG Placebo
  • DRUG JNJ-64565111 Dose Level 1
  • DRUG JNJ-64565111 Dose Level 2
  • DRUG JNJ-64565111 Dose Level 3

Study Locations (20)

California

  • National Research Institute - Los Angeles
  • Rancho Cucamonga Clinical Trials - Rancho Cucamonga
  • Sierra Clinical Research - Roseville
  • Encompass Clinical Research - Spring Valley
  • Diablo Clinical Research, Inc. - Walnut Creek

Florida

  • Premeir Clinical Research Institute - Miami
  • International Research Associates, LLC - Miami
  • CNS HealthCare - Orlando
  • Translational Research Institute for Metabolism and Diabetes - Orlando

Ohio

  • Prestige Clinical Research - Franklin
  • Albert J. Weisbrot and Associates - Mason

Pennsylvania

  • Clinical Research Associates of Central PA, LLC - Altoona
  • Heritage Valley Medical Group - Beaver

Alabama

  • Central Research Associates, Inc. - Birmingham

Indiana

  • Buynak Clinical Research - Valparaiso

Kansas

  • Cotton-O'Neil Clinical Research Center - Topeka

Maryland

  • M.D. Medical Research - Oxon Hill

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2018-06-26
Est. Completion 2019-04-05
Phase Phase 2
Janssen Research & Development

593 total trials

What the finished NCT03586830 record still lists

NCT03586830 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% higher).

The record links to 1 condition, with Obesity and Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT03586830 names 20 study sites across 11 states, led by California, Florida, Ohio.

Frequently Asked Questions

What is clinical trial NCT03586830 about?

NCT03586830 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus". 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.

What is the current status of trial NCT03586830?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2018-06-26. Estimated completion is 2019-04-05.

What conditions does trial NCT03586830 study?

This clinical trial studies the following conditions: Obesity and Diabetes Mellitus, Type 2.

What interventions are being tested in trial NCT03586830?

The interventions under investigation include: Placebo (DRUG), JNJ-64565111 Dose Level 1 (DRUG), JNJ-64565111 Dose Level 2 (DRUG), JNJ-64565111 Dose Level 3 (DRUG).

Who is sponsoring clinical trial NCT03586830?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03586830 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obesity and Diabetes Mellitus, Type 2

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03586830's enrollment target sits among peer trials

196 349th of 2000 higher than 1,651 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03586830, the US trial registry maintained by the National Library of Medicine. NCT03586830 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.