Trial · NCT00025883
Leptin to Treat Lipodystrophy
NCT00025883, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2016-08-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leptin to Treat Lipodystrophy. Trials, record NCT00025883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00025883
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leptin to Treat Lipodystrophy
- NCT number
- NCT00025883
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 103 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Lipodystrophy
- Interventions
- Metreleptin
- First posted
- 2001-10-29
- Last updated
- 2016-08-16
- Results first posted
- 2016-08-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Baseline, 6 months, 12 months | Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin |
| Primary | Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Baseline, 6 months, 12 months |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Baseline, 6 months, 12 months | percentage of glycated hemoglobin | MEAN | |
| PRIMARY | Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Baseline, 6 months, 12 months | mg/dL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Generalized Lipodystrophy (GLD) | Baseline | 8.4 | Standard Deviation 2.3 | percentage of glycated hemoglobin |
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Partial Lipodystrophy (PLD) | Baseline | 8.1 | Standard Deviation 2.2 | percentage of glycated hemoglobin |
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Generalized Lipodystrophy (GLD) | 6 months | 6.6 | Standard Deviation 1.7 | percentage of glycated hemoglobin |
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Partial Lipodystrophy (PLD) | 6 months | 7.2 | Standard Deviation 1.2 | percentage of glycated hemoglobin |
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Generalized Lipodystrophy (GLD) | 12 months | 6.4 | Standard Deviation 1.5 | percentage of glycated hemoglobin |
| Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Partial Lipodystrophy (PLD) | 12 months | 7.3 | Standard Deviation 1.6 | percentage of glycated hemoglobin |
| Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Generalized Lipodystrophy (GLD) | Baseline | 467 | Inter-Quartile Range 200 to 847 | mg/dL |
| Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Partial Lipodystrophy (PLD) | Baseline | 483 | Inter-Quartile Range 232 to 856 | mg/dL |
| Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Generalized Lipodystrophy (GLD) | 6 months | 198 | Inter-Quartile Range 122 to 283 | mg/dL |
| Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin | Partial Lipodystrophy (PLD) | 6 months | 339 | Inter-Quartile Range 211 to 530 | mg/dL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metreleptin | 103 | |
| Overall Study | Generalized Lipodystrophy | Metreleptin | 63 | |
| Overall Study | Partial Lipodystrophy | Metreleptin | 40 | |
| Overall Study | COMPLETED | Metreleptin | 86 | |
| Overall Study | NOT COMPLETED | Metreleptin | 17 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Metreleptin | 8 | 103 | 9 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Metreleptin | 15 | 103 | 19 |
| other | Infection | Infections and infestations | Metreleptin | 7 | 103 | 12 |
| other | Anxiety | General disorders | Metreleptin | 6 | 103 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Metreleptin | 6 | 103 | 6 |
| other | Hypoglycemia | Endocrine disorders | Metreleptin | 10 | 103 | 12 |
| other | Weight loss | Metabolism and nutrition disorders | Metreleptin | 12 | 103 | 12 |
| other | tumor, benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Metreleptin | 6 | 103 | 6 |
| other | Fatigue | Endocrine disorders | Metreleptin | 7 | 103 | 8 |
| other | Insomnia | General disorders | Metreleptin | 5 | 103 | 5 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metreleptin | ||
| Total, other adverse events | Metreleptin | 64 | 103 |
| Total, serious adverse events | Metreleptin | 10 | 103 |
Source ClinicalTrials.gov
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00025883
GET https://conductscience.org/api/trials/v1/NCT00025883/events?page=2