A Study of RM-718 in Healthy Subjects and in Patients With HO

Hypothalamic Obesity Clinical Trial

Official title: A Study of RM-718 Weekly Formulation in Healthy Subjects With Obesity and in Patients With Hypothalamic Obesity (HO)

Status Recruiting

Clinical Trial 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 hypothalamic obesity (HO).

Clinical Trial Description

This is a first-in-human and first-in-patient, 3-part study that includes the evaluation of safety, tolerability, and PK of: single ascending doses (SAD) of RM-718 weekly (RM-718) in healthy subjects 18 to 55 years of age with obesity (Part A), multiple ascending doses (MAD) of RM-718 in healthy subjects 18 to 55 years of age with obesity (Part B), and MAD of RM-718 in patients 12 to 65 years of age with HO (Part C). Cohorts in Parts A and B are double-blind, placebo-controlled, and randomized 2:1 (4 subjects receive RM-718, 2 subjects receive placebo). Part C evaluates open-label dose escalation in patients 12 to 65 years of age with HO. Study participants will receive: 1 weekly dose of either RM-718 or placebo in Part A, 4 weekly doses of either RM-718 or placebo in Part B, and 4 weekly doses of open-label RM-718 in Part C. Study drug (RM-718 or placebo) doses are administered weekly via subcutaneous injection. ;

Related Conditions & MeSH terms

• Hypothalamic Obesity
• Obesity

• NCT number: NCT06239116
• Study type: Interventional
• Source: Rhythm Pharmaceuticals, Inc.
• Contact: Rhythm Clinical Trials
• Phone: (857) 264-4280
• Email: clinicaltrials@rhythmtx.com
• Status: Recruiting
• Phase: Phase 1
• Start date: March 5, 2024
• Completion date: June 30, 2025