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Pregnancy and Metreleptin Use in Women with Lipodystrophy

This study looks at how pregnancy and its outcomes are affected in women with lipodystrophy (a condition where the body doesn't have enough fat tissue) who have taken metreleptin (a medicine that acts like the hormone leptin) compared to those who haven't. Researchers want to understand if metreleptin helps or harms pregnant women and their babies. They will collect information on pregnancy complications and also check if babies born to mothers who took metreleptin have anti-leptin antibodies. You may be able to join if you are a woman aged 18 or older with lipodystrophy who has been pregnant. The study aims to enroll 90 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any new treatments. It will involve women with lipodystrophy who have had pregnancies, with or without metreleptin exposure, and their offspring.
What's involved
The study involves reviewing existing medical records and, if needed, collecting a single blood sample. It also uses data and samples from other studies you may have participated in.
Compensation
Not stated in the trial record.
Follow-up
Pregnancy complications will be measured at the end of the study. It is not specified how long participants are followed after this.

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NCT05419037

Natural History of Pregnancy and Pregnancy Outcomes in Metreleptin-Treated vs Untreated Subjects With Lipodystrophy

Recruiting
Not specifiedAges 6–98Observational
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~90 participants
Updated 2026-08-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
type and frequency of pregnancy complications
Measured over at end of study

Conditions

Lipodystrophy

Explore related trials

Lipodystrophy

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Rebecca J Brown, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Megan S Startzell, R.N.
[email protected]
(301) 402-6371
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Inability of subject or guardian to understand or the unwillingness to sign a written informed consent document (except as noted below with \*)
Pregnancy.

What this trial measures

  • type and frequency of pregnancy complicationsat end of study

    We will quantify a set of pregnancy and offspring outcomes and complications.