Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 69 participants
Start Date 2021-12-17
Est. Completion 2026-10-31
Phase Phase 3

Sponsor

Amryt Pharma

4 total trials

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.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.