Setmelanotide for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Obesity+2 More
Setmelanotide - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether setmelanotide can help people with obesity who have gene variants that affect the melanocortin-4 receptor pathway.

Eligible Conditions
  • Obesity
  • Single-Gene Defects

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: From baseline to End of Treatment, up to 40 weeks. Total participation in the study will last up to 52 weeks, including the Screening Period and the EOS Visit.

Week 52
The proportion of obese patients with genetic defects in the MC4R pathway who achieve a clinically meaningful reduction in body weight
Hypesthesia

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Setmelanotide
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Setmelanotide · Has Placebo Group · Phase 2

Setmelanotide
Drug
ActiveComparator Group · 1 Intervention: Setmelanotide · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to end of treatment, up to 40 weeks. total participation in the study will last up to 52 weeks, including the screening period and the eos visit.

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
22 Previous Clinical Trials
7,897 Total Patients Enrolled
14 Trials studying Obesity
1,526 Patients Enrolled for Obesity
Murray Stewart, BM/DMStudy ChairRhythm Pharmaceuticals, Inc.
5 Previous Clinical Trials
276 Total Patients Enrolled
4 Trials studying Obesity
199 Patients Enrolled for Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
1 Previous Clinical Trials
150 Total Patients Enrolled
1 Trials studying Obesity
150 Patients Enrolled for Obesity

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity.
You have a body mass index of at least 40 kg/m2 or a body mass index of at least 97th percentile for age and gender.
You are able to understand the study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New Jersey100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%