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The Effects of Metreleptin in Congenital Leptin Deficiency

NCT04063488 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2021-12-30

No results posted yet for this study

Summary

This study has been designed to 1) provide access to metreleptin to the only two individuals in the US known to have congenital leptin deficiency (CLD) and 2) explore a variety of unanswered questions about leptin physiology in general and metreleptin therapy in CLD specifically.

The primary study endpoints include the following measures: body composition, measures of hepatic steatosis, measures of insulin sensitivity, and measures of sleep architecture.

Secondary study endpoints include assessment of clock gene expression, body temperature, thyroid function, gonadal function, cognitive function, eating behavior, physical activity, mood, quality of life, and body image.

Conditions

  • Congenital Leptin Deficiency (Disorder)

Interventions

DRUG

Metreleptin

This is an observational study in which the subjects will serve as their own controls. Study testing will be conducted at baseline (pre-treatment) and for 2 years, post-treatment with metreleptin.

Sponsors & Collaborators

Principal Investigators

  • Lisa Neff, MD · Dr.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-08-13
Completion
2021-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04063488 on ClinicalTrials.gov