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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: Active Phase 3 study of Partial Lipodystrophy, sponsored by Amryt Pharma.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment
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 |
What the registry record for NCT05164341 still lists
NCT05164341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Partial Lipodystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05164341's enrollment target sits among peer trials
69 1794th of 2000 higher than 205 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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