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
Participants must have had a pre-identified genetic variant in an established MC4R pathway gene that contributes to obesity
Age 6 to 65 years, inclusive
Obesity, defined as Body Mass Index (BMI) ≥40 kilograms per square meter (kg/m\^2) for participants ≥18 years of age or BMI ≥97th percentile for age and gender for participants 6 to \<18 years of age
Study participant and/or parent or guardian were able to understand all study procedures and provide consent/assent
Use of highly effective contraception
Symptoms or behaviors of hyperphagia
You may not be if
Participants with the following genetic variants: biallelic Bardet-Biedl Syndrome (BBS); biallelic Alström Syndrome 1 (ALMS1); homozygous, heterozygous, or compound heterozygous variants in MC4R, Pro-opiomelanocortin (POMC), Proprotein convertase subtilisin/kexin type 1 (PCSK1), Leptin receptor (LEPR), nuclear receptor coactivator 1 (NCOA1; steroid receptor coactivator-1 \[SRC1\]) or SRC homology 2 B adapter protein 1 (SH2B1) genes as well as 16p11.2 chromosomal deletions that included the SH2B1 gene
Recent intensive diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that had resulted in weight loss \>2% within previous 3 months
Bariatric surgery within the previous 6 months
Documented diagnosis of current unstable major psychiatric disorder or a documented worsening of psychiatric condition that required changes in treatment within 2 years
Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) or Patient Health Questionnaire 9 (PHQ 9) score of ≥15 during Screening, any suicide attempt in participant's lifetime years, or any suicidal behavior in the last month.
Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study
Has significant features of (or meets the diagnostic criteria for) a genetic syndrome that is associated with obesity
Glycated hemoglobin (HbA1C) \>10.0% at Screening
History of significant liver disease
Glomerular filtration rate (GFR) \<30 milliliter per minute (mL/min) at Screening
History or close family history of melanoma or participant history of oculocutaneous albinism
Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions
Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
Significant hypersensitivity to any excipient in the study drug
Females who were breastfeeding or nursing
Clareo Health | DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
