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

NCT06239116 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-22

No results posted yet for this 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

Interventions

DRUG

Part 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)

DRUG

Part 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)

DRUG

Part C: RM-718

Multiple ascending doses of RM-718

DRUG

Part D: RM-718

Multiple ascending doses of RM-718

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2027-11-01
Completion
2028-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239116 on ClinicalTrials.gov