Active — Not RecruitingPhase 3

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

United States69 participantsStarted 2021-12-17

Plain-language summary

This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Familial Partial Lipodystrophy (FPLD) * Subjects with poor metabolic control defined as: HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3) * Patients should be receiving optimized stable therapy Exclusion Criteria: * Previous treatment with metreleptin * Leptin levels \>20.0 ng/mL * Acquired or radiation induced partial lipodystrophy (APL) Other protocol defined inclusion/exclusion criteria apply

What they're measuring

Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)

Timeframe: 6 months

Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)

Timeframe: 6 months

Trial details

NCT IDNCT05164341

SponsorAmryt Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-21

View on ClinicalTrials.gov More Partial Lipodystrophy trials