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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 trial is testing an injection called setmelanotide to help people with hypothalamic obesity lose weight. This condition is caused by damage to a part of the brain that controls hunger and energy use, making it hard to treat with regular methods. The medication aims to help by regulating appetite and energy. Setmelanotide has been approved in the USA for chronic weight management.
Eligible Conditions
- Hypothalamic Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug up to day 141
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to day 141
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 moreOther 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 moreSide effects data
From 2022 Phase 4 trial • 77 Patients • NCT0504613246%
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
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
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