Active — Not RecruitingPhase 3

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

United States120 participantsStarted 2023-04-26

Plain-language summary

The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.

Who can participate

Age range4 Years

SexALL

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Inclusion criteria

✓. Documented evidence of acquired hypothalamic obesity (HO)
✓. Age 4 years and older
✓. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \<18 years of age
✓. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study

Exclusion criteria

✕. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
✕. Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years
✕. Bariatric surgery or procedure within last 2 years
✕. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
✕. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
✕. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
✕. History or close family history of skin cancer or melanoma
✕. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose

What they're measuring

Mean % change in BMI

Timeframe: From Baseline after 52 weeks on a therapeutic regimen

Trial details

NCT IDNCT05774756

SponsorRhythm Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-18

View on ClinicalTrials.gov More Hypothalamic Obesity trials