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NCT04966741 · ClinicalTrials.gov registry record · Phase 3
Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity
A Phase 3 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 12
- Enrollment target
NCT04966741: Completed Phase 3 study, sponsored by Rhythm Pharmaceuticals.
NCT04966741 is a Phase 3 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 12 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04966741, a Phase 3 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genes or Bardet-Biedl Syndrome (BBS).
Primary Outcome
A "responder" was defined as a decrease from baseline to 52 weeks in the participant's BMI z-score of ≥0.2. BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. The BMI Z-scores were based on the World Health Organization's Child Growth Standards 2007 and indicated the number of standard deviations away from the mean. A Z-score of 0 was equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decr
Interventions
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-03-08 |
| Est. Completion | 2024-11-08 |
| Phase | Phase 3 |
What the finished NCT04966741 record still lists
NCT04966741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Setmelanotide is the first listed.
NCT04966741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04966741 about?
NCT04966741 is a clinical study titled "Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity". This is a phase 3 open-label, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric participants aged 2 to \<6 years with obesity due to either biallelic variants of the pro-opiomelanocortin (POMC), proprotein convertase subtilisin/k...
What is the current status of trial NCT04966741?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 12 participants. The study started on 2022-03-08. Estimated completion is 2024-11-08.
What interventions are being tested in trial NCT04966741?
The interventions under investigation include: Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT04966741?
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 NCT04966741's enrollment target sits among peer trials
12 1984th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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