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

NCT05419037 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

Summary

Background:

Lipodystrophy is a health problem in which the body does not have enough fat tissue. People with lipodystrophy may not make enough of the hormone leptin. Leptin regulates hunger. Low leptin levels trigger hunger. People with lipodystrophy can have many health problems. They may take a drug (metreleptin) that mimics leptin. Little is known about how taking metreleptin may affect a pregnancy. Metreleptin may be helpful or harmful to pregnant women. It may also affect the health of the child who is born.

Objective:

This natural history study will collect data about the effects of taking metreleptin while pregnant.

Eligibility:

Women aged 18 years or older with lipodystrophy who have been pregnant. Women who did and who did not take metreleptin during their pregnancies are needed. Children of women with lipodystrophy who took this drug during pregnancy are also needed.

Design:

Participants will have 1 study visit. This visit may be by phone, by telehealth, or in-person.

Participants will answer questions about their pregnancies.

They will discuss any health problems they had.

They will be asked about any medicines they took before and during their pregnancies.

They will be asked about the health of their children.

Participants medical records will be reviewed.

Participants may need to provide a blood sample. They may also be asked to provide a sample of breastmilk.

Participants children may also be asked to provide a blood sample....

Conditions

  • Lipodystrophy

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

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

Eligibility

Min Age
6 Months
Max Age
98 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2028-03-01
Completion
2029-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05419037 on ClinicalTrials.gov