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NCT06239116 · ClinicalTrials.gov registry record · Phase 1
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
A Phase 1 study of Prader-Willi Syndrome and Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 7
- Study locations
NCT06239116: Recruiting Phase 1 study of Prader-Willi Syndrome and Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals.
NCT06239116 is a Phase 1 study of Prader-Willi Syndrome and Hypothalamic Obesity that is actively recruiting participants, run by Rhythm Pharmaceuticals. The registered enrollment target is 150 participants, above the 62-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (142% higher). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06239116, a Phase 1 study of Prader-Willi Syndrome and Hypothalamic Obesity, is actively recruiting participants, sponsored by Rhythm Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
Conditions Studied
Interventions
- DRUG Part A: RM-718 or placebo (matched to specific RM-718 dose cohort)
- DRUG Part B: RM-718 or placebo (matched to specific RM-718 dose cohort)
- DRUG Part C: RM-718
- DRUG Part D: RM-718
Study Locations (7)
Massachusetts
- Boston Children's Hospital (Part C only) - Boston
- Brigham and Women's Hospital (Part C and Part D) - Boston
Alabama
- UAB Pediatric Endocrinology (Part C and Part D) - Birmingham
Illinois
- Ann and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D) - Chicago
Tennessee
- Vanderbilt University Medical Center (Part C only) - Nashville
Texas
- Worldwide Clinical Trials (Part A and Part B) - San Antonio
Utah
- University of Utah Pediatric Endocrine Clinic (Part C and Part D) - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-03-05 |
| Est. Completion | 2028-11-01 |
| Phase | Phase 1 |
What NCT06239116 shows while recruiting
NCT06239116 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 62-participant average among 16 other Prader-Willi Syndrome trials with a reported enrollment target (142% higher).
The record links to 3 conditions, with Prader-Willi Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) is the first listed.
NCT06239116 lists 7 locations in 6 states (Massachusetts, Alabama, Illinois).
Frequently Asked Questions
What is clinical trial NCT06239116 about?
NCT06239116 is a clinical study titled "A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment". The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment
What is the current status of trial NCT06239116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2024-03-05. Estimated completion is 2028-11-01.
What conditions does trial NCT06239116 study?
This clinical trial studies the following conditions: Prader-Willi Syndrome, Hypothalamic Obesity, PWS.
What interventions are being tested in trial NCT06239116?
The interventions under investigation include: Part A: RM-718 or placebo (matched to specific RM-718 dose cohort) (DRUG), Part B: RM-718 or placebo (matched to specific RM-718 dose cohort) (DRUG), Part C: RM-718 (DRUG), Part D: RM-718 (DRUG).
Who is sponsoring clinical trial NCT06239116?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06239116 being conducted?
This trial has 7 study locations across Alabama, Illinois, Massachusetts, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06239116's enrollment target sits among peer trials
150 2nd of 16 the highest of 16 other Prader-Willi Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prader-Willi Syndrome 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.
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