Trials / Active Not Recruiting
Active Not RecruitingNCT05164341
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Amryt Pharma · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | metreleptin | 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 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2021-12-17
- Primary completion
- 2026-07-21
- Completion
- 2026-10-31
- First posted
- 2021-12-20
- Last updated
- 2025-08-29
Locations
31 sites across 9 countries: United States, Belgium, Brazil, Canada, Chile, Israel, Netherlands, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05164341. Inclusion in this directory is not an endorsement.