← Back to Search

Melanocortin 4 Receptor (MC4R) 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

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

No Placebo-Only Group

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

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With ≥ 5% Reduction in BMI From Baseline After 16 Weeks of Setmelanotide Treatment

Secondary study objectives

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 study objectives

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

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

Abdominal pain

Constipation

Pancreatitis acute

Hepatitis acute

Asthenia

Chills

Injection site induration

Medical device site dermatitis

Aphthous ulcer

Change of bowel habit

Chapped lips

Diarrhoea

Gingival discolouration

Hyperaesthesia teeth

Pruritus

Rash

Cough

Dry throat

Dyspnoea

Rhinorrhoea

Muscle spasms

Pain in extremity

Palpitations

Skin abrasion

Blood creatine phosphokinase increased

Abnormal dreams

100%

80%

60%

40%

20%

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.

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

~800

Do I qualify?Apply below to find out