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A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus
NCT03586830 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2019-04-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03586830
The ClinicalTrials.gov registry entry for NCT03586830 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03586830 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03586830?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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