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
6–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must have a pre-identified:
* Heterozygous genetic variant in the POMC gene or PCSK1 gene
* Heterozygous genetic variant in the LEPR gene
* Homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1)
* Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, or chromosomal 16p11.2 deletion encompassing the SH2B1 gene
Between 6 and 65 years of age at the time of provision of informed consent/assent
Obesity, defined as BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and gender for patients 6 up to 17 years of age
Patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
Patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood
Agree to use a highly effective form of contraception throughout the study and for 90 days following the study
Reported history of lifestyle intervention of diet and exercise
Reported history of hyperphagia
You may not be if
Weight loss of 2% or greater in the previous 3 months
Recent history of bariatric surgery
Significant psychiatric disorder(s)
Suicidal ideation, attempt or behavior
Clinically significant pulmonary, cardiac, endocrine/metabolic, hepatic or oncologic disease
Glycated hemoglobin (HbA1C) \>10% at Screening
History of significant liver disease or severe kidney disease
History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism
Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
Significant hypersensitivity to any excipient in the study drug
