Study to Evaluate the Safety and Efficacy of Daily Subcut... | NCT05164341 | Trialant

Study to Evaluate the Safety and Efficacy of Daily Subcut... | NCT05164341 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metreleptin	Active Comparator	Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake	Drug: metreleptin
placebo	Placebo Comparator	Placebo for daily injection is a sterile, white, solid lyophilised cake	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metreleptin	Drug	Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency	metreleptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)	To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment	6 months
Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)	To evaluate the efficacy (TGs) of daily SC metreleptin treatment	6 months

Secondary Outcomes

Measure	Description	Time Frame
Safety analysis of AEs, AESIs, SAEs by treatment arm	To evaluate the safety of daily SC metreleptin treatment in subjects with PL	12 months
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)