Setmelanotide para el manejo del peso en la obesidad hipotalámica

Fecha de inicio: 7 de junio de 2021

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. * Ability to communicate well with the Investigator, understand and comply with the requirements of the study, and understand and sign the written informed consent, or, for participants aged \<18 years, a parent/legal guardian that can sign. * If receiving hormone replacement therapy, the dose of such therapy has remained stable for at least 2 months prior to Screening. Exclusion Criteria: Participants meeting any of the following criteria are not eligible for study participation: * 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. * Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide. * Inability to comply with QD injection regimen. * Pregnant and/or breastfeeding, or desiring to become pregnant during this trial. * Cognitive impairment that, in the Investigator's opinion, precludes participation to the study and completions of study procedures or questionnaires. * Participant is, in Investigator's opinion, otherwise not suitable to participate in the study.