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NCT00025883 · ClinicalTrials.gov registry record · Phase 2
Leptin to Treat Lipodystrophy
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 103
- Enrollment target
NCT00025883: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00025883 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00025883, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 103 participants
- Enrollment target
Study Summary
This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes high blood lipid (fat) levels and insulin resistance that may lead to diabetes. Patients may have hormone imbalances, fertility problems, large appetite, and liver disease due to fat accumulation. Patients age greater than or equal to 6 months with significant lipodystrophy may be eligible for this study. Participants will be admitted to the NIH Clinical Center for 10 days for the following studies before beginning 12 months of leptin therapy: * Insulin tolerance test * Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. * Fasting blood tests * Resting metabolic rate * Magnetic resonance imaging of the liver and other organs, and of muscle and fat. * Pelvic ultrasound in women to detect ovarian cysts. * Estimation of body fat * Oral glucose tolerance test * Intravenous glucose tolerance test * Appetite level and food intake * Hormone function tests * Questionnaires to assess activity and mood * 24-hour urine collections Additional studies may include blood tests for genetic studies of lipodystrophy, a muscle biopsy to study muscle proteins involved in regulating energy expenditure before and after leptin replacement, and examination of a surgical specimen (if available) to study molecules that may be involved in energy storage and use. When the above tests are completed, leptin therapy begins. The drug is injected under the skin twice a day for 4 months and then once a day, if feasible. The dose is increased at the 1- and 2-month visits. Follow-up visits at 1, 2, 4, 6, 8 and 12 months after therapy starts include a physical examination, blood tests and a meeting with a dietitian. At the end of 12 months, all baseline studies described above
Primary Outcome
Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin
Interventions
- DRUG Metreleptin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2001-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT00025883 record still lists
NCT00025883 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Metreleptin is the first listed.
NCT00025883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00025883 about?
NCT00025883 is a clinical study titled "Leptin to Treat Lipodystrophy". This study will evaluate the safety and effectiveness of leptin replacement therapy in patients with lipodystrophy (also called lipoatrophy). Patients have a total or partial loss of fat cells. They also lack the hormone leptin, which is produced by fat cells. The leptin deficiency usually causes hi...
What is the current status of trial NCT00025883?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2001-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00025883?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT00025883?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00025883's enrollment target sits among peer trials
103 664th of 2000 higher than 1,333 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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