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Open-Label Study of Setmelanotide in Hypothalamic Obesity | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Open-Label Study of Setmelanotide in Hypothalamic Obesity

A Phase 2, Open-Label 20-Week Study to Evaluate the Safety and Efficacy of Setmelanotide in Subjects With Hypothalamic Obesity

NCT04725240•Rhythm Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Open-label, single-arm study designed to evaluate the body weight response to setmelanotide administered subcutaneously (SC) daily in participants with hypothalamic obesity (HO).

Eligibility

Age

6 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all of the following criteria to be eligible for study participation:
•Participant has documented evidence of HO, including:
•* Recent evidence of hypothalamic injury on magnetic resonance imaging (MRI); AND
•* Diagnosis of craniopharyngioma or other non-malignant brain tumor affecting the hypothalamic region; AND
•* Has undergone surgery, or chemotherapy, or radiation ≥6 months and ≤15 years before Screening.
•Participant has either unilateral hypothalamic lesions or bilateral hypothalamic lesions, as assessed by MRI.
•Obesity, documented by a body mass index (BMI) ≥35 kilograms/square meter (kg/m\^2) for participants ≥18 years of age or BMI ≥95th percentile for age and gender for participants 6 to \<18 years of age.
•Documented increase in BMI (change from pre-surgery baseline in BMI z-score ≥0.2 for participants \<18 years of age or BMI \>5% for participants \>18 years of age) either during the first 6 months following surgery or within 1 year before surgery AND still present at Screening.
•More than 6 months after the end of post-tumor treatment, including chemotherapy, surgery, or radiation.
•Highly effective contraception throughout the study and for 90 days following the study.
+2 more criteria

Exclusion Criteria

•Weight gain \>5% in the previous 3 months.
•Weight loss ≥2% in the previous 3 months.
•Bariatric surgery or procedure within the last 6 months.
•Diagnosis of severe psychiatric disorders
•Glycated hemoglobin (HbA1c) \>10.0% at Screening.
•Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results.
•Glomerular filtration rate (GFR) \<30mL/min/1.73m\^2 during Screening.
•Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions.
•History or close family history (parents or siblings) of skin cancer or melanoma
•Participation in any clinical study with an investigational drug/device within 3 months or 5 half-lives, whichever is longer, prior to the first setmelanotide dose.
+5 more criteria

Locations (5)

Rady Children's Hospital

San Diego, California, United States

University of Florida

Gainesville, Florida, United States

Children's Minnesota

Saint Paul, Minnesota, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Key Dates

Start Date

June 7, 2021

Primary Completion Date

June 28, 2022

Completion Date

June 28, 2022

Last Updated

February 7, 2025

Enrollment

ACTUAL participants

Conditions

Hypothalamic Obesity

Interventions

Setmelanotide

DRUG

A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

NCT07156578

Hypothalamic Obesity

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UNKNOWNEARLY_PHASE1

The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study

NCT06217848

PanhypopituitarismCraniopharyngioma+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open-Label Study of Setmelanotide in Hypothalamic Obesity

Inclusion Criteria

Exclusion Criteria

A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)

The Effect of GLP-1 Agonist in Patients With Hypothalamic Obesity: Prospective, Pilot Study

Energy Balance & Weight Loss in Craniopharyngioma-related or Other Hypothalamic Tumors in Hypothalamic Obesity

Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy