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New study investigates pregnancy risks for women on rare Fat-Disorder drug

NCT ID NCT05419037

Knowledge-focused 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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This study looks at women with lipodystrophy, a condition causing abnormal fat tissue, who have been pregnant. Researchers want to see if taking the drug metreleptin during pregnancy affects the mother's or child's health. About 90 women and their children will share medical history and samples. The goal is to gather information, not to test a new 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.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Mar 2029

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.

Who is studied

Women who were pregnant while taking metreleptin and their off-spring will be evaluated.

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: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Women with lipodystrophy who had pregnancies with or without use of metreleptin: * Female, aged \>= 18 years * Clinical diagnosis of non-HIV associated generalized or partial lipodystrophy * History of one or more pregnancies * Offspring of women with lipodystrophy who had pregnancies while taking metreleptin: * Males or females aged \>=1 month * Mothers took metreleptin during their pregnancy * Availability of a biobanked blood specimen or willingness to provide a blood specimen Note that subjects treated with metreleptin during pregnancy may participate in this study regardless of the participation of their offspring. EXCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must not meet any of the following criteria: * Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \*) * Pregnancy. * Subjects who otherwise meet inclusion/exclusion criteria but who are not reachable to obtain informed consent may be included under a waiver of consent.

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Conditions

The condition(s) this trial relates to.

lipodystrophy

As listed by the trial registrant

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

Lipodystrophy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

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