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

A 12-Month Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With Partial Lipodystrophy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05164341

Acronym

METRE-PL

Enrollment

Registered

2021-12-20

Start date

2021-12-17

Completion date

2026-10-31

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Lipodystrophy

Keywords

metreleptin

Brief summary

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

Interventions

DRUGmetreleptin

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Safety analysis of AEs, AESIs, SAEs by treatment arm	12 months	To evaluate the safety of daily SC metreleptin treatment in subjects with PL
Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)	12 months	To assess the effect of metreleptin on HbA1c
Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)	12 months	To assess the effect of metreleptin on TGs
Change from Baseline to each assessment time point in quality of life (QoL) in all subjects	12 months	To assess the effect of metreleptin on quality of life (QoL) in all subjects

Countries

Belgium, Brazil, Canada, Chile, Israel, Netherlands, Poland, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026