CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Metreleptindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04026178
NCT04026178Phase 4Completed
CompareCT.gov

A 36-Month, Multicenter, Open Label Phase 4 Study to Evaluate the Immunogenicity of Daily SC Metreleptin Treatment in Patients With Generalized Lipodystrophy

Aegerion Pharmaceuticals, Inc.·interventional·Posted Jul 19, 2019·Updated Nov 26, 2025

In Brief

A Phase 4 clinical trial evaluating Metreleptin for Generalized Lipodystrophy. Completed, enrolled 11 participants across 8 sites.

Detailed Summary

MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Lipodystrophy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartNov 14, 2018
Primary CompletionOct 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 7.0 years ago

Interventions

Metreleptindrug

Subjects will receive prescribed dosage of metreleptin as indicated in the USPI