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New hope for rare fat disorder: daily leptin shots target blood sugar and fats

NCT ID NCT05164341

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a daily injection of metreleptin (a lab-made leptin hormone) can improve blood sugar and fat levels in people with partial lipodystrophy, a rare condition where fat is distributed abnormally. About 69 participants will receive either metreleptin or a placebo for 12 months. The main goals are to see if the drug lowers HbA1c and triglycerides.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
metreleptin (a lab-made version of the hormone leptin)
What this could lead to
If successful, this could provide a new treatment option to help control blood sugar and triglycerides in people with partial lipodystrophy.
What could go wrong
This is a relatively small Phase 3 trial, and results may not apply to all patients. Metreleptin requires daily injections and may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

69 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Familial Partial Lipodystrophy (FPLD) * Subjects with poor metabolic control defined as: HbA1c ≥7% (at Visit 1 and Visit 3) and/or Fasting TGs ≥500 mg/dL (5.65 mmol/L, at Visit 1 and Visit 3) * Patients should be receiving optimized stable therapy Exclusion Criteria: * Previous treatment with metreleptin * Leptin levels \>20.0 ng/mL * Acquired or radiation induced partial lipodystrophy (APL) Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

acquired partial lipodystrophy familial partial lipodystrophy partial lipodystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Partial lipodystrophy

Contacts and locations

Locations

  • Amryt Research Site, Endocrinology Research Associates Inc

    Columbus, Ohio, 43201, United States

  • Care Access Clinic

    Sydney, Nova Scotia, B1M 0A1, Canada

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9, Canada

  • Emory University

    Atlanta, Georgia, 30329, United States

  • Faculty of Medicine, Universite Laval

    Québec, Quebec, G1V4W2, Canada

  • Flourish Boca Raton

    Boca Raton, Florida, 33431, United States

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, Israel

  • Hamilton General Hospital- McMaster University

    Hamilton, Ontario, L8N 3Z5, Canada

  • Hospital das Clinicas FMRP-USP

    Ribeirão Preto, Brazil

  • Insight Centro de Pesquisas

    Porto Alegre, Brazil

  • Instituto Estadual de Diabetes e Endocrinologia (IEDE-RJ)

    Rio de Janeiro, Brazil

  • Leids Universitair Medisch Centrum

    Leiden, Netherlands

  • London Health Science Centre

    London, Ontario, N6A 5B7, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Nova Scotia Health

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Radboud University Medical Centre Interne Geneeskund

    Nijmegen, Netherlands

  • SPZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Poland

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UC Davis

    Sacramento, California, 95817, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UZ Leuven

    Leuven, Belgium

  • Universidad Catolica

    Santiago, Chile

  • University Clinical Hospital of Santiago de Compostela/Hospital Universitario

    Santiago de Compostela, Spain

  • University of Alabama

    Birmingham, Alabama, 35233, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Missouri

    Columbia, Missouri, 65212, United States

  • Universitário Walter Cantídio

    Fortaleza, Brazil

  • Uniwersyteckie Centrum Kliniczne

    Katowice, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.