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The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway:
The objectives and endpoints are identical for these sub-studies.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria:
Patients must have a pre-identified:
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
Key Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
400 participants in 4 patient groups
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Physician Inquiry: Clinical Trials; Rhythm Clinical Trials
Data sourced from clinicaltrials.gov
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