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

EU CTIS

Registry ID

CTIS2022-501799-24-00

Acronym

APG-20

Enrollment

Registered

2023-02-02

Start date

2024-03-07

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

partial lipodystrophy

Brief summary

Change from Baseline to Month 6 in glycated hemoglobin (HbA1c) in subjects with FPLD in Groups A and C (HbA1c ≥7%), Percent change from Baseline to Month 6 in fasting triglycerides (TGs) in subjects with FPLD in Groups B and C (TG ≥500 mg/dL [5.65 mmol/L])

Detailed description

Change from Baseline to Month 6 in FBG in Groups A and C (HbA1c ≥7%), Change from Baseline to Month 6 in FBG in subjects with FBG above upper limit of normal (ULN)

Interventions

DRUGMetreleptin for injection (placebo)

DRUGMyalepta 11.3 mg powder for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from Baseline to Month 6 in glycated hemoglobin (HbA1c) in subjects with FPLD in Groups A and C (HbA1c ≥7%), Percent change from Baseline to Month 6 in fasting triglycerides (TGs) in subjects with FPLD in Groups B and C (TG ≥500 mg/dL [5.65 mmol/L])	—

Secondary

Measure	Time frame
Change from Baseline to Month 6 in FBG in Groups A and C (HbA1c ≥7%), Change from Baseline to Month 6 in FBG in subjects with FBG above upper limit of normal (ULN)	—

Countries

Belgium, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026