CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 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/NCT02654977
NCT02654977Phase 2Completed
CompareCT.gov

CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Recombinant Human Leptin (METRELEPTIN) in Various Forms of Partial Lipodystrophy

University of Michigan·interventional·Posted Jan 13, 2016·Updated Nov 24, 2020

In Brief

A Phase 2 clinical trial evaluating Metreleptin for Familial Partial Lipodystrophy and 2 related conditions. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The study investigators' aim is to determine the long term safety and efficacy of Metreleptin (Myalept,) in promoting amelioration of metabolic abnormalities in patients with all forms of partial lipodystrophy. Patients will be offered this protocol under the following condition: Subjects have completed University of Michigan research protocol MB002-014 and have shown improved clinical benefit as judged by clinical criteria set forth in this protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFamilial Partial Lipodystrophy, Nonalcoholic Steatohepatitis, NAFLD
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 13, 2016
Enrollment StartSep 29, 2015
Primary CompletionNov 14, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.5 years ago

Interventions

Metreleptindrug

MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections