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Melanocortin-4 Receptor Agonist

Setmelanotide for 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
Patients must have a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity
Age 6 to 65 years, inclusive
Must not have
Patients previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
Patients with the following genetic variants: biallelic Bardet-Biedl Syndrome (BBS); biallelic Alström Syndrome 1 (ALMS1); homozygous, heterozygous, or compound heterozygous variants in MC4R, POMC, PCSK1, LEPR, nuclear receptor coactivator 1 (NCOA1; steroid receptor coactivator-1 [SRC1]) or SRC homology 2 B adapter protein 1 (SH2B1) genes as well as 16p11.2 chromosomal deletions that include the SH2B1 gene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of stage 1 (16 weeks)
Awards & highlights

Summary

This trial tests setmelanotide, a medication to help control weight, in obese patients with specific genetic defects. These patients have issues that make typical treatments less effective. Setmelanotide helps reduce hunger and increase energy use. It has been approved in the USA for weight management.

Who is the study for?
This trial is for people aged 6-65 with severe obesity linked to specific genetic changes in the MC4R pathway. Participants must understand the study, use effective birth control, and have a BMI ≥40 kg/m2 (adults) or ≥97th percentile for their age/gender (children). Excluded are those with certain other genetic conditions, recent bariatric surgery, significant health issues like liver disease or melanoma risk, psychiatric disorders, or recent weight loss treatments.
What is being tested?
The DAYBREAK study tests Setmelanotide's effectiveness on obesity due to MC4R pathway gene variants. It starts with an open-label phase where everyone gets Setmelanotide followed by a blind phase where participants randomly receive either Setmelanotide or a placebo without knowing which one they're getting.
What are the potential side effects?
While not specified here, potential side effects of Setmelanotide may include reactions at the injection site, increased pigmentation of skin or hair, nausea and possibly others based on its action in regulating appetite and energy expenditure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a genetic variant linked to obesity.
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I am between 6 and 65 years old.
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I often feel an uncontrollable urge to eat.
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I am considered obese based on my BMI.
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I (or my guardian) understand the study and can consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never participated in a study or taken setmelanotide before.
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I have specific genetic conditions related to obesity.
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I or my close family have had melanoma, or I have a history of albinism.
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I have serious skin changes related to melanoma or almost-melanoma.
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I do not have severe lung, heart, or cancer-related health issues that could affect the study.
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I have a history of serious liver disease.
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My kidney function is low, with a GFR under 30 mL/min.
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I have a genetic condition linked to obesity.
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I am currently breastfeeding.
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I've lost more than 2% of my weight in the last 3 months due to diet, exercise, or weight loss supplements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of stage 1 (16 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of stage 1 (16 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of patients by genotype who achieve MC4R pathway who achieve a ≥5% reduction in BMI
Secondary study objectives
Mean change and percent change in BMI in all patients and patients ≥18 years old, per gene
Mean change and percent change in body weight in patients ≥18 years old, per gene
Mean change in BMI Z-score in patients <18 years old, per gene
+2 more

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SetmelanotideExperimental Treatment1 Intervention
Patients with specific gene variants in the MC4R pathway on setmelanotide
Group II: PlaceboPlacebo Group1 Intervention
Patients with specific gene variants in the MC4R pathway on placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setmelanotide
2017
Completed Phase 4
~640

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
Common treatments for obesity include lifestyle interventions, pharmacotherapy, and bariatric surgery. Lifestyle interventions focus on diet and exercise to create a calorie deficit. Pharmacotherapy includes drugs like orlistat, which inhibits fat absorption, and GLP-1 agonists like semaglutide, which enhance satiety and reduce appetite. Setmelanotide, an MC4R agonist, works by activating the melanocortin-4 receptor pathway, which plays a crucial role in regulating hunger and energy expenditure. This is particularly important for obesity patients with specific genetic mutations affecting this pathway, as it directly addresses the underlying cause of their weight gain, offering a more targeted and potentially effective treatment option.

Find a Location

Who is running the clinical trial?

Rhythm Pharmaceuticals, Inc.Lead Sponsor
27 Previous Clinical Trials
10,181 Total Patients Enrolled
19 Trials studying Obesity
3,816 Patients Enrolled for Obesity
Murray Stewart, BM/DMStudy ChairRhythm Pharmaceuticals, Inc.
5 Previous Clinical Trials
338 Total Patients Enrolled
4 Trials studying Obesity
261 Patients Enrolled for Obesity
David Meeker, MDStudy ChairRhythm Pharmaceuticals, Inc.
14 Previous Clinical Trials
1,443 Total Patients Enrolled
10 Trials studying Obesity
1,173 Patients Enrolled for Obesity

Media Library

Setmelanotide (Melanocortin-4 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04963231 — Phase 2
Obesity Research Study Groups: Setmelanotide, Placebo
Obesity Clinical Trial 2023: Setmelanotide Highlights & Side Effects. Trial Name: NCT04963231 — Phase 2
Setmelanotide (Melanocortin-4 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963231 — Phase 2
Obesity Patient Testimony for trial: Trial Name: NCT04963231 — Phase 2
~40 spots leftby Sep 2025
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