A Trial of Setmelanotide in Acquired Hypothalamic Obesity

ID#: NCT05774756

Age: 4 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Enrolling by invitation

Start Date: April 26, 2023

End Date: April 16, 2025

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 up to 60 weeks.
Eligibility: Key

Inclusion Criteria:

1. Documented evidence of acquired hypothalamic obesity (HO)

2. Age 4 years and older

3. 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

4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study Key

Exclusion Criteria:

1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)

2. 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

3. Bariatric surgery or procedure within last 2 years

4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior

5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease

6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)

7. History or close family history of skin cancer or melanoma

8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose

9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide

10. Inability to comply with once daily (QD) injection regimen

11. If female, pregnant and/or breastfeeding

12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL [POMC, PCSK1, LEPR, collectively], BBS) prior to the hypothalamic injury.

13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening Other protocol defined Inclusion/Exclusion criteria may apply.
Find a Clinical Trial Find Cancer Clinical Trials