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Experimental drug targets rare fat Disorder's metabolic woes

NCT ID NCT05088460

Disease control Sponsor: Regeneron Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested a drug called REGN4461 (mibavademab) in 20 people with familial partial lipodystrophy, a rare condition causing abnormal fat distribution and metabolic problems. The study aimed to see if the drug could lower high triglycerides and improve blood sugar control. However, the trial was terminated early, so full results are not available.

What this could mean

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

Active substance
REGN4461 (mibavademab)
What this could lead to
If it works, this could point toward a treatment to control metabolic problems like high triglycerides and blood sugar in people with familial partial lipodystrophy.
What could go wrong
The trial was terminated early, so results are limited. It was a small phase 2 study with only 20 participants, so findings may not apply broadly.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

20 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2024

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

18 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.

Key Inclusion Criteria: * Clinical diagnosis of familial partial lipodystrophy as defined in the protocol * Fasting leptin level ≤20.0 ng/ml, as determined during the screening period * Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol * Stable body weight within the 3 months prior to screening (no gain or loss of \>5% current weight) * Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism) * No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol Key Exclusion Criteria: * Treatment with metreleptin within 3 months of the screening visit * Patients with a diagnosis of generalized lipodystrophy * Patients with a diagnosis of acquired lipodystrophy * Pregnant or breastfeeding women NOTE: Other protocol defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

familial partial lipodystrophy metabolic disease

As listed by the trial registrant

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

Familial partial lipodystrophy Metabolic abnormalities

Contacts and locations

Locations

  • Complexo Hospitalario Universitario de Santiago-Hospital Médico-Cirúrxico de Conxo

    Santiago de Compostela, Galicia, 15706, Spain

  • Ege University Faculty of Medicine

    Izmir, Bornova, 35100, Turkey (Türkiye)

  • Excel Medical Clinical Trials - A Flourish Research Site

    Boca Raton, Florida, 33434, United States

  • ICAN, Institute of Cardiometabolism and Nutrition

    Paris, 75013, France

  • National Institute of Health

    Bethesda, Maryland, 20892, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

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