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Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

NCT05194124 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-11-26

Study results available
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Summary

A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.

Conditions

Interventions

DRUG

Setmelanotide 2 mg

Administered as SC injection

DRUG

Setmelanotide 2.5 mg

Administered as SC injection

DRUG

Setmelanotide 3 mg

Administered as SC injection

DRUG

Setmelanotide 20 mg

Administered as SC injection

DRUG

Setmelanotide 25 mg

Administered as SC injection

DRUG

Setmelanotide 30 mg

Administered as SC injection

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2023-10-19
Completion
2023-10-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • Puerto Rico
  • United Kingdom

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 NCT05194124 on ClinicalTrials.gov