RecruitingPhase 1Phase 2NCT06239116

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

A Study of RM-718 Weekly Formulation in Healthy Subjects With Obesity and in Patients With Obesity Due to MC4R Impairment

Sponsor

Rhythm Pharmaceuticals, Inc.

Enrollment

150 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Prader-Willi Syndrome Hypothalamic Obesity PWS

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

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Part A: RM-718 or placebo (matched to specific RM-718 dose cohort), a drug called Part B: RM-718 or placebo (matched to specific RM-718 dose cohort), and others for people with hypothalamic obesity, pws, and other related conditions. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 12 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPart A: RM-718 or placebo (matched to specific RM-718 dose cohort)

Single ascending dose of RM-718 or placebo (matched to specific RM-718 Part A dose cohort)

DRUGPart B: RM-718 or placebo (matched to specific RM-718 dose cohort)

Multiple ascending doses of RM-718 or placebo (matched to specific RM-718 Part B dose cohorts)

DRUGPart C: RM-718

Multiple ascending doses of RM-718

DRUGPart D: RM-718

Multiple ascending doses of RM-718

Locations(7)

UAB Pediatric Endocrinology (Part C and Part D)

Birmingham, Alabama, United States

Ann and Robert H. Lurie Children's Hospital of Chicago (Part C and Part D)

Chicago, Illinois, United States

Boston Children's Hospital (Part C only)

Boston, Massachusetts, United States

Brigham and Women's Hospital (Part C and Part D)

Boston, Massachusetts, United States

Vanderbilt University Medical Center (Part C only)

Nashville, Tennessee, United States

Worldwide Clinical Trials (Part A and Part B)

San Antonio, Texas, United States

University of Utah Pediatric Endocrine Clinic (Part C and Part D)

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06239116

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