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NCT Number: NCT06484868

Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy

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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 4

Primary location

Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of familial or acquired partial lipodystrophy

Exclusion criteria

  • Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.

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

Primary outcomes

  1. Number of patients with decrease of at least 0.5% in glycated haemoglobin (HbA1c) at Month 12 compared to Baseline or HbA1c <6.5 % at Month 12, in patients with baseline HbA1c ≥6.5%.

    Time frame: 12 months

    To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL

  2. Number of patients with decrease of at least 30% in triglycerides (TG) at Month 12 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L)

    Time frame: 12 months

    To evaluate the efficacy (TG) of metreleptin treatment in patients with PL

Secondary outcomes

  1. Number of patients with decrease of at least 0.5% in HbA1c at Month 24 compared to Baseline or HbA1c <6.5 % at Month 24, in patients with baseline HbA1c ≥6.5%.

    Time frame: 24 months

    To evaluate the long-term efficacy of metreleptin treatment in patients with PL

  2. Number of patients with decrease of at least 30% in TG levels at Month 24 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L).

    Time frame: 24 months

    To evaluate the long-term efficacy of metreleptin treatment in patients with PL

  3. Change from baseline in liver volume at Month 12 and Month 24

    Time frame: 12 months and 24 months

    To assess changes in liver volume.

  4. Incidence of, Treatment emergent adverse events (TEAEs), Deaths and other serious adverse events (SAEs), Treatment related adverse events (AEs), AEs of special interest (AESIs) and AEs leading to study drug discontinuation

    Time frame: 24 months

    To evaluate the safety of metreleptin treatment in patients with PL

Study contacts

Contact information is provided by the study sponsor or research team.

Janet Boylan

CONTACT

[email protected]

+3905212791

Sponsors and collaborators

Lead sponsor

Amryt Pharma

Industry

Registry information

Official study title

A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2025

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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