DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway

Exclusion Criteria

• •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