Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rhythm Pharmaceuticals, Inc.
Age
6–40
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
