Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02262806 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 168 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Re-verified, no change to tracked fields
  3. Minor Re-verified, no change to tracked fields
  4. Minor Study description expanded, about 2 words
  5. Minor 22 versions Re-verified since Jun 13, 2025, no change to tracked fieldsv143-v164
Show 24 earlier versionsHide 24 earlier versions
  1. Notable Primary and study completion dates: Jul 31, 2025 to Jul 31, 2027 Enrollment target: 30 to 29v142 Show 1 more changeShow less
    • Enrollment target: 30 to 29
  2. Minor 2 versions Re-verified since Feb 8, 2025, no change to tracked fieldsv140-v141
  3. Minor Study Status, Study Descriptionv139
  4. Minor 15 versions Re-verified since Sep 8, 2022, no change to tracked fieldsv124-v138
  5. Minor Study Status, Contacts/Locationsv123
  6. Minor 4 versions Re-verified since Jul 5, 2022, no change to tracked fieldsv119-v122
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: \- Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: \- To test the safety and effectiveness of metreleptin. Eligibility: * People age 6 months and older with partial lipodystrophy who * have received metreleptin through NIH studies and shown improvement AND * cannot get metreleptin other ways. Design: * Participants will come to NIH approximately every 6 months during year one, then every 1 2 years. Financial assistance may be available for travel within the U.S. * At visits, participants will get a supply of metreleptin to take home for daily injections, or it can be shipped to them inside the U.S. They will have: * plastic catheter placed in an arm vein. * blood tests, urine collection, and physical exam. * oral glucose tolerance test, drinking a sweet liquid. * ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the skin and pictures are taken of the organs. * echocardiogram, which takes pictures of the heart with sound waves. * Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they breathe is measured. * Participants will have up to 3 DEXA scan x-rays per year. * Participants may have: * annual bone x-rays. * liver biopsies every few years. A needle will be inserted into the liver to obtain a small piece. Participants will sign a separate consent for this. * Participants must be seen regularly by their local doctors and have blood tests at least every 3-6 months at home.
Trial Details
NCT Number NCT02262806
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Diabetes, Lipodystrophy, Hyperlipidemia
Enrollment 29 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov