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New drug shows promise for rare fat disorder

NCT ID NCT04159415

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called REGN4461 in 16 people with generalized lipodystrophy, a rare condition where the body can't store fat properly, leading to severe metabolic problems. The drug aims to improve blood sugar and triglyceride levels. Participants received either the drug or a placebo for 8 weeks to see if it helps control these issues.

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

16 people

The number who actually took part.

Started

Jan 2020

Finished

Sep 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

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.

Key Inclusion Criteria: * Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol * Presence of one or both of the following metabolic abnormalities at screening: 1. HbA1c ≥ 7% OR 2. Fasting TG ≥250 mg/dL * Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit Key Exclusion Criteria: * Treatment with metreleptin within 1 month of the screening visit * Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit * Treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids \>7.5 mg prednisone equivalents per day during the study period * History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit * Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening * Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit. * Pregnant or breast-feeding women NOTE: Other protocol defined inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

generalized lipodystrophy Lipodystrophy, Congenital Generalized

As listed by the trial registrant

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

Generalized lipodystrophy

Contacts and locations

Locations

  • Regeneron Research Site

    Bethesda, Maryland, 20892, United States

  • Regeneron Research Site

    Ann Arbor, Michigan, 48105, United States

  • Regeneron Research Site

    Dallas, Texas, 75390, United States

  • Regeneron Research Site

    Piura, 2665, Peru

  • Regeneron Research Site

    Moscow, 117036, Russia

  • Regeneron Research Site

    Ankara, 06230, Turkey (Türkiye)

  • Regeneron Research Site

    Diyarbakır, 21808, Turkey (Türkiye)

  • Regeneron Research Site

    Izmir, 35100, Turkey (Türkiye)

More trials for these conditions

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