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Melanocortin 4 Receptor (MC4R) Agonist

Setmelanotide for Hypothalamic 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 60
Awards & highlights

Summary

This trial will test if an injection can reduce weight & hunger in children & adults with acquired Hypothalamic Obesity. Participants take daily injections & complete assessments up to 60 weeks to see if it works & is safe.

Who is the study for?
This trial is for people aged 4 and older with acquired Hypothalamic Obesity, marked by weight gain after hypothalamic injury. Adults must have a BMI of ≥30 kg/m2, while children need a BMI in the top 95th percentile. Participants should agree to use effective contraception during and post-trial.Check my eligibility
What is being tested?
The study tests Setmelanotide's effectiveness on weight reduction, hunger control, and life quality in HO patients compared to placebo. It involves daily injections and assessments over up to 60 weeks.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions at the injection site, general discomfort or changes related to hormone activity due to Setmelanotide's role as an appetite regulator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean % change in BMI
Secondary outcome measures
Mean BMI-z score and BMI percentile reduction in patients <18 (using combined height and weight to report BMI in kg/m2)
Mean change in Symptoms of Hyperphagia total score
Mean change in physical functioning score and total score for the Impact of Weight on Quality of Life-Lite (IWQOL)
+8 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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SetemelanotideExperimental Treatment1 Intervention
Randomized 2:1 (Setmelanotide: Placebo)
Group II: PlaceboPlacebo Group1 Intervention
Randomized 2:1 (Setmelanotide: Placebo)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
2017
Completed Phase 4
~650

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hypothalamic Obesity (HO) often target the central melanocortin pathways, which play a crucial role in regulating energy balance and appetite. Setmelanotide, an MC4R agonist, works by activating the melanocortin 4 receptor, which helps reduce hunger and promote weight loss. This is particularly important for HO patients, as their condition is characterized by severe obesity and hyperphagia due to hypothalamic damage. By targeting these pathways, treatments like Setmelanotide can help manage the symptoms of HO more effectively, improving both weight and quality of life for patients.
Role of secretin peptide family and their receptors in the hypothalamic control of energy homeostasis.New central targets for the treatment of obesity.Melanocortin 4 receptor-mediated hyperphagia and activation of neuropeptide Y expression in the dorsomedial hypothalamus during lactation.

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
10,211 Total Patients Enrolled
3 Trials studying Hypothalamic Obesity
136 Patients Enrolled for Hypothalamic Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
14 Previous Clinical Trials
1,473 Total Patients Enrolled
2 Trials studying Hypothalamic Obesity
46 Patients Enrolled for Hypothalamic Obesity

Media Library

Hypothalamic Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT05774756 — Phase 3
~42 spots leftby Apr 2025