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Hope for rare fat disorder: drug keeps working in Long-Term study

NCT ID NCT02262806

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11 times

Summary

This study gives the drug metreleptin to 29 people with partial lipodystrophy, a rare condition that causes high blood fats and diabetes. Participants have already shown improvement from the drug in earlier studies. The goal is to keep providing the treatment and check its long-term safety and effectiveness with regular blood tests and exams.

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

29 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 * Age greater than or equal to 6 months * Partial lipodystrophy (either genetic or acquired) * Previously or currently treated with metreleptin under NIH study 02-DK-0022 and/or NIH study 13-DK-0057. * Documented metabolic benefit from prior or current metreleptin treatment, defined as one or more of the following: * TG reduction greater than or equal to 30% OR * HbA1c reduction greater than or equal to 1% OR * Decrease in insulin requirements greater than or equal to 40% OR * Decrease in episodes of pancreatitis OR * Improvement in steatohepatitis OR * Withdrawal of metreleptin led to marked worsening of metabolic parameters EXCLUSION CRITERIA * Availability of metreleptin to the patient either as an approved drug, or through local compassionate use or expanded access programs. * Known HIV infection or HIV-associated lipodystrophy. * Psychiatric disorder impeding competence or compliance. * Any medical condition or medication that will increase risk to the subject. * Current alcohol or substance abuse. * Subjects who have a known hypersensitivity to E. coli derived proteins.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus hyperlipidemia hypertriglyceridemia lipodystrophy partial 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.