Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03651765 · ClinicalTrials.gov registry record · Phase 2
Long Term Extension Trial of Setmelanotide
A Phase 2 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
NCT03651765: Completed Phase 2 study, sponsored by Rhythm Pharmaceuticals.
NCT03651765 is a Phase 2 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651765, a Phase 2 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
Study Summary
This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.
Primary Outcome
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that began or worsened in intensity on or after the date of the first administration of study drug.
Interventions
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2018-07-15 |
| Est. Completion | 2025-01-09 |
| Phase | Phase 2 |
What the finished NCT03651765 record still lists
NCT03651765 is an interventional study that assigns participants to a tested intervention. The registered 205 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 (54% higher).
The record links to 0 conditions, and to 1 intervention - of which Setmelanotide is the first listed.
NCT03651765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03651765 about?
NCT03651765 is a clinical study titled "Long Term Extension Trial of Setmelanotide". This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the ...
What is the current status of trial NCT03651765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2018-07-15. Estimated completion is 2025-01-09.
What interventions are being tested in trial NCT03651765?
The interventions under investigation include: Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT03651765?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03651765's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03457493 · 205 participants · Phase 1
The University of Alabama At Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
- NCT05134857 · 205 participants · Phase 2
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
- NCT05181891 · 205 participants · Phase 2
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
- NCT05283811 · 205 participants · NA
Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI