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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 is a Phase 1 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 99 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02041195
The ClinicalTrials.gov registry entry for NCT02041195 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02041195 reports 0 study locations.
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.
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