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Lifesaving drug made available for rare fat disorder patients

NCT ID NCT02262832

Disease control Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 10 times

Summary

This study gives the drug metreleptin to people with generalized lipodystrophy, a rare condition that causes severe fat loss and leads to high blood fats and diabetes. Participants, aged 6 months and older, have already received metreleptin in past NIH studies but cannot get it in their home country. The goal is to keep their blood fats and blood sugar under control with ongoing treatment.

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

24 people

The number who actually took part.

Started

Oct 2014

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

6 months to 98 years

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: 1. Age greater than or equal to 6 months. 2. Generalized lipodystrophy (either congenital or acquired). 3. Those who cannot obtain metreleptin through approved or compassionate use mechanisms in their home country. EXCLUSION CRITERIA: 1. Availability of metreleptin to the patient either as an approved drug, or through local compassionate use or expanded access programs. 2. Known HIV infection or HIV-associated lipodystrophy. 3. Any medical condition or medication that will increase risk to the subject. 4. Current alcohol or substance abuse. 5. Subjects who have a known hypersensitivity to E. coli derived proteins (as leptin is derived from such proteins).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus generalized lipodystrophy hyperlipidemia hypertriglyceridemia lipodystrophy

As listed by the trial registrant

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

Diabetes Hyperlipidemia Lipodystrophy

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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