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Melanocortin 4 Receptor (MC4R) Agonist

Setmelanotide for Hypothalamic Obesity

Phase 2
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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug up to day 141
Awards & highlights

Summary

This study is evaluating whether a drug may help reduce appetite and weight in individuals with hypothalamic obesity.

Eligible Conditions
  • Hypothalamic Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to day 141
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to day 141 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment
Secondary outcome measures
Change From Baseline in Daily Hunger Questionnaire Score in Participants Aged <12 Years After 16 Weeks of Setmelanotide Treatment
Change From Baseline in Daily Hunger Questionnaire Scores in Participants Aged ≥12 Years After 16 Weeks of Setmelanotide Treatment
Change From Baseline in Waist Circumference in Participants Aged ≥18 Years After 16 Weeks of Setmelanotide Treatment
+6 more
Other outcome measures
Change in BMI (kg/m2) in subjects 6-12 years
Change in BMI (kg/m2) in subjects 6-19 years
Change in metabolic parameters, HBA1c mmol/mol in subjects 6-12 years
+7 more

Side effects data

From 2022 Phase 4 trial • 77 Patients • NCT05046132
52%
Injection site pain
26%
Injection site erythema
17%
Injection site swelling
4%
Dizziness
4%
Abdominal pain
4%
Dry throat
4%
Arthralgia
4%
Medical device site dermatitis
4%
Injection site pruritus
4%
Palpitations
4%
Injection site induration
4%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 2: Moxifloxacin 400mg
Group 1: Setmelanotide 3 mg
Group 1: Setmelanotide 5 mg
Group 1: Setmelanotide 2 mg
Group 3: Moxifloxacin 400mg
Group 1: Setmelanotide 7 mg
Group 2: Placebo
Group 3: Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: SetmelanotideExperimental Treatment1 Intervention
Participants received setmelanotide once daily (QD) via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and dose escalated up to a maximum dose of 3.0 milligrams (mg) QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
2017
Completed Phase 4
~650

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
10,313 Total Patients Enrolled
3 Trials studying Hypothalamic Obesity
238 Patients Enrolled for Hypothalamic Obesity
Murray Stewart, BM/DMStudy ChairRhythm Pharmaceuticals, Inc.
5 Previous Clinical Trials
470 Total Patients Enrolled
Linda Shapiro, MD, PhDStudy ChairRhythm Pharmaceuticals, Inc.
2 Previous Clinical Trials
97 Total Patients Enrolled
~4 spots leftby Jul 2025