Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway

Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period

Time frame · Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1

Maximum drug concentration determined directly from individual concentration-time data.

Cmax of Setmelanotide After QW Administration

Time frame · Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14

Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period

Time frame · Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1

Maximum drug concentration determined directly from individual concentration-time data.

Tmax of Setmelanotide After QW Administration

Time frame · Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14

Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1

Time frame · 30 minutes predose at Week 1

Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Mean Setmelanotide Ctrough After QD or QW Administration at Week 5

Time frame · 30 minutes predose at Week 5

Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Mean Setmelanotide Ctrough After QD or QW Administration at Week 9

Time frame · 30 minutes predose at Week 9

Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Mean Setmelanotide Ctrough After QD or QW Administration at Week 18

Time frame · 30 minutes predose at Week 18

Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame · From first dose of study drug administration up to Week 30

An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The AEs reported after the start of the run-in period were considered TEAEs.

Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13

Time frame · Baseline through Week 13

The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Baseline was defined as the last available measurement prior to the first dose of setmelanotide or placebo. Injection site reactions frequency of once daily (QD) and once weekly (QW) were reported. Data are reported by dose level (treatment regimen) in the DB Period. Number of participants with injection site reactions according to severity were reported.

Number of Participants With ISRs From Week 14 Through Week 27

Time frame · Week 14 through Week 27

The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Injection site reactions frequency of QD and QW were reported. Data are reported by dose level (treatment regimen) in the OL Period. Number of participants with injection site reactions according to severity were reported.