← Back to Search

Setmelanotide for Obesity

Phase 3
Waitlist Available
Research Sponsored by Rhythm Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Any new or worsening depression resulting in suicidal thoughts and/or behaviors
Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

"This trial is looking at how safe and well-tolerated it is to continue giving setmelanotide to male and female patients over 2 years old who have rare genetic, syndromic,

Who is the study for?
This trial is for males and females aged 2 years or older who have obesity due to rare genetic, syndromic, or acquired conditions affecting the MC4R pathway. Participants must have previously completed or transitioned from a setmelanotide study.
What is being tested?
The trial is testing the long-term safety and effectiveness of continued treatment with Setmelanotide, a medication aimed at treating obesity by targeting specific pathways related to weight regulation.
What are the potential side effects?
While not specified here, common side effects of Setmelanotide may include injection site reactions, nausea, vomiting, increased skin pigmentation and potential impact on blood pressure or heart rate.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have experienced new or worsening depression with suicidal thoughts or behaviors.
Select...
I have a condition treatable with setmelanotide (IMCIVREE®).
Select...
My family (parents or siblings) or I have a history of melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 4 trial • 77 Patients • NCT05046132
46%
Nausea
39%
Injection site pain
29%
Vomiting
25%
Injection site erythema
21%
Ephelides
21%
Decreased appetite
18%
Skin hyperpigmentation
14%
Injection site swelling
14%
Headache
14%
Erection increased
11%
Injection site pruritus
11%
Fatigue
7%
Abdominal pain
7%
Constipation
4%
Pancreatitis acute
4%
Hepatitis acute
4%
Asthenia
4%
Chills
4%
Injection site induration
4%
Medical device site dermatitis
4%
Aphthous ulcer
4%
Change of bowel habit
4%
Chapped lips
4%
Diarrhoea
4%
Gingival discolouration
4%
Hyperaesthesia teeth
4%
Pruritus
4%
Rash
4%
Cough
4%
Dry throat
4%
Dyspnoea
4%
Rhinorrhoea
4%
Muscle spasms
4%
Pain in extremity
4%
Palpitations
4%
Skin abrasion
4%
Blood creatine phosphokinase increased
4%
Abnormal dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Setmelanotide 2 mg
Group 1: Setmelanotide 3 mg
Group 2: Moxifloxacin 400mg
Group 1: Setmelanotide 5 mg
Group 1: Setmelanotide 7 mg
Group 2: Placebo
Group 3: Placebo
Group 3: Moxifloxacin 400mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Setelanotide (Open-label)Experimental Treatment1 Intervention
Once daily (QD) subcutaneous injection of setmelanotide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
2017
Completed Phase 4
~800

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
28 Previous Clinical Trials
10,345 Total Patients Enrolled
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
15 Previous Clinical Trials
1,607 Total Patients Enrolled
~20 spots leftby Oct 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top