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Recruiting Phase 1Phase 2 Interventional Accepts healthy volunteers

A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment

NCT06239116
Conditions
Hypothalamic Obesity, Prader-Willi Syndrome, PWS
Interventions
Part A: RM-718 or placebo (matched to specific RM-718 dose cohort), Part B: RM-718 or placebo (matched to specific RM-718 dose cohort), Part C: RM-718, Part D: RM-718
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
12 Years to 65 Years
Enrollment
150 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2028
U.S. locations
7
States / cities
Birmingham, Alabama • Chicago, Illinois • Boston, Massachusetts + 3 more
Conditions
Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years and older
Enrollment
213 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2022
U.S. locations
43
States / cities
Birmingham, Alabama • Chandler, Arizona • Mesa, Arizona + 37 more
Conditions
Prader-Willi Syndrome
Interventions
Setmelanotide, Placebo
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
16 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
5
States / cities
Irvine, California • Gainesville, Florida • Kansas City, Kansas + 2 more
Conditions
Prader-Willi Syndrome, Obesity, Hyperphagia
Interventions
Setmelanotide
Drug
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Eligibility
6 Years to 65 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Gainesville, Florida
Conditions
Melanocortin Obesity Syndrome, MCOS
Interventions
Atomoxetine, Placebo
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
6 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
2
States / cities
New York, New York • Nashville, Tennessee