← Back to Search

Leptin Analog

Metreleptin for Partial Lipodystrophy (METRE-PL Trial)

Phase 3

Recruiting

Research Sponsored by Amryt Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Familial Partial Lipodystrophy (FPLD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

METRE-PL Trial Summary

This trial is testing whether a daily injection of metreleptin is safe and effective for people with Partial Lipodystrophy.

Who is the study for?

This trial is for individuals with a condition called Partial Lipodystrophy, specifically those diagnosed with Familial Partial Lipodystrophy (FPLD). It's not open to people who have already been treated with metreleptin.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a daily injection of a drug called metreleptin compared to a placebo. This is done in a controlled way where neither the participants nor the researchers know who gets the real treatment or placebo.See study design

What are the potential side effects?

Possible side effects from metreleptin may include low blood sugar, weight loss, headaches, abdominal pain, and allergic reactions at the injection site.

METRE-PL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Familial Partial Lipodystrophy.

METRE-PL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL)

Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL)

Secondary outcome measures

Change from Baseline to each assessment time point in quality of life (QoL) in all subjects

Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL)

Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL)

+1 more

METRE-PL Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: metreleptinActive Control1 Intervention

Metreleptin [Recombinant-methionyl human Leptin; r-metHuLeptin] for daily injection is a sterile, white, solid lyophilised cake

Group II: placeboPlacebo Group1 Intervention

Placebo for daily injection is a sterile, white, solid lyophilised cake

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Amryt PharmaLead Sponsor

4 Previous Clinical Trials

353 Total Patients Enrolled

Media Library

metreleptin (Leptin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05164341 — Phase 3

Partial Lipodystrophy Research Study Groups: metreleptin, placebo

Partial Lipodystrophy Clinical Trial 2023: metreleptin Highlights & Side Effects. Trial Name: NCT05164341 — Phase 3

metreleptin (Leptin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05164341 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has metreleptin received approval from the Federal Drug Administration?

"The safety of metreleptin is estimated to be a 3. This assessment comes from Phase 3 trial data, which provides some evidence of the medication's efficacy as well as multiple rounds of supporting data for safety."

Answered by AI

Are people with the specific condition being studied presently able to enroll in this trial?

"Yes, this trial is still open and looking for participants. The listing on clinicaltrials.gov says that the first posting was on December 17th, 2021 and the last update was on November 2nd, 2022."

Answered by AI

Could you tell me how many people are testing this new medication?

"Yes, according to the latest update on clinicaltrials.gov, this study is still enrolling patients. The listing was first posted on December 17th, 2021 and updated as recently as November 2nd, 2022. They are looking for a total of 65 participants across 1 site."

Answered by AI

Does metreleptin have a long research history?

"Currently, there are 5 ongoing clinical trials studying the effects of metreleptin. Out of these 5, 2 are in Phase 3. The research being conducted is primarily based in Columbus, Ohio; however, there are 14 trial locations across the United States."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL

2021. "Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05164341.