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NCT05164341 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
A Phase 3 study of Partial Lipodystrophy, sponsored by Amryt Pharma.
- Active
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 20
- Study locations
NCT05164341 is a Phase 3 study of Partial Lipodystrophy that is active but no longer recruiting, run by Amryt Pharma. The registered enrollment target is 69 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT05164341, a Phase 3 study of Partial Lipodystrophy, is active but no longer recruiting, sponsored by Amryt Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG metreleptin
Study Locations (20)
Other
- UZ Leuven - Leuven
- Universitário Walter Cantídio - Fortaleza
- Insight Centro de Pesquisas - Porto Alegre
- Hospital das Clinicas FMRP-USP - Ribeirão Preto
- Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ) - Rio de Janeiro
Ohio
- Amryt Research Site, Endocrinology Research Associates Inc - Columbus
- The Ohio State University Wexner Medical Center - Columbus
Nova Scotia
- Nova Scotia Health - Halifax
- Care Access Clinic - Sydney
Alabama
- University of Alabama - Birmingham
California
- UC Davis - Sacramento
Florida
- Flourish Boca Raton - Boca Raton
Georgia
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05164341
The ClinicalTrials.gov registry entry for NCT05164341 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amryt Pharma, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Partial Lipodystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05164341 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Ohio, Nova Scotia.
Frequently Asked Questions
What is clinical trial NCT05164341 about?
NCT05164341 is a clinical study titled "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.
What is the current status of trial NCT05164341?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2021-12-17. Estimated completion is 2026-10-31.
What conditions does trial NCT05164341 study?
This clinical trial studies the following conditions: Partial Lipodystrophy.
What interventions are being tested in trial NCT05164341?
The interventions under investigation include: Placebo (DRUG), metreleptin (DRUG).
Who is sponsoring clinical trial NCT05164341?
This trial is sponsored by Amryt Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05164341 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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