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NCT Number: NCT05164341

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Partial Lipodystrophy Lipodystrophy, Partial, Acquired

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UZ Leuven, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Placebo

Drug

Placebo

Primary outcomes

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

    Time frame: 6 months

    To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment

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

    Time frame: 6 months

    To evaluate the efficacy (TGs) of daily SC metreleptin treatment

Secondary outcomes

  1. Safety analysis of AEs, AESIs, SAEs by treatment arm

    Time frame: 12 months

    To evaluate the safety of daily SC metreleptin treatment in subjects with PL

  2. Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)

    Time frame: 12 months

    To assess the effect of metreleptin on HbA1c

  3. Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)

    Time frame: 12 months

    To assess the effect of metreleptin on TGs

  4. Change from Baseline to each assessment time point in quality of life (QoL) in all subjects

    Time frame: 12 months

    To assess the effect of metreleptin on quality of life (QoL) in all subjects

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Acronym: METRE-PL

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2021
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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