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NCT02041195 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients
A Phase 1 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 99
- Enrollment target
NCT02041195: Completed Phase 1 study, sponsored by Rhythm Pharmaceuticals.
NCT02041195 is a Phase 1 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 99 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02041195, a Phase 1 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 99 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designed to evaluate the efficacy and tolerability of setmelanotide administered once or twice daily. The study drug (setmelanotide and placebo) will be administered in a blinded fashion.
Interventions
- DRUG Placebo
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
What the finished NCT02041195 record still lists
NCT02041195 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02041195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02041195 about?
NCT02041195 is a clinical study titled "Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients". The purpose of this study is to evaluate the effects of a new daily subcutaneous (SC) injectable formulation of setmelanotide (RM-493) in healthy participants with obesity on mean percent body weight loss and other weight loss parameters, as well as pharmacokinetic (PK) profile. The study is designe...
What is the current status of trial NCT02041195?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2014-01. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02041195?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT02041195?
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 NCT02041195's enrollment target sits among peer trials
99 590th of 2000 higher than 1,409 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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