Acquired hypothalamic obesity (HO)
Conditions
Interventions
Patients who are eligible to enter the trial will be randomized in a blinded manner on Day 1 in a 2:1 ratio, stratified by age group (>-18 years old, >-12 and <18 years old, <12 years old) and subpopu
Sponsors
Flaherty Jim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient has documented evidence of acquired HO 2.Aged 4 years and older 3.Documented weight gain associated with the hypothalamic injury either, and a body mass index (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.A highly effective form of contraception must be used/practiced throughout the trial and for 90 days 5.If receiving hormone replacement therapy, the dose of such therapy has remained stable for at least 2 months prior to Screening Other protocol defined Inclusion criteria may apply.
Exclusion criteria
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 the last 2 years 4.Diagnosis of severe psychiatric disorders, or any suicidal ideation, attempts, or any suicidal 5.Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered 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.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.Hypersensitivity to setmelanotide and/or any excipients contained in the investigational drug Other protocol defined Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean % change in BMI from Baseline after approximately 52 weeks on a therapeutic regimen of setmelanotide compared to placebo | — |
Countries
Canada, Germany, Japan, Netherlands, United Kingdom, United States
Contacts
Public ContactKaori Sogame
CMIC Co., Ltd.
Outcome results
None listed