Trial · NCT02654977
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
NCT02654977, Phase 2, Completed, University of Michigan; results first posted 2020-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy. Trials, record NCT02654977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654977
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
- NCT number
- NCT02654977
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Familial Partial Lipodystrophy, Nonalcoholic Steatohepatitis, NAFLD
- Interventions
- Metreleptin
- First posted
- 2016-01-13
- Last updated
- 2020-11-24
- Results first posted
- 2020-11-24
- Limitations and caveats
- Definitive conclusions cannot be drawn from sample sizes as small as the four individuals who completed the trial period.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Fasting Triglyceride Levels | 5 years on metreleptin or last observation carried forward | Fasting triglyceride levels after 5 years on metreleptin, measured in mg/dL are compared to fasting triglyceride levels at baseline). The median percent increase (positive numbers) or decrease from baseline is shown, along with the full range. |
| Secondary | Percent Change in Hemoglobin A1c Levels | 5 years on metreleptin or last observation carried forward | Fasting hemoglobin A1c levels after 5 years on metreleptin, measured in % are compared to fasting Hemoglobin levels at baseline). Thus, for example, a change from 10% to 5% would be a -50% change (or 50% decrease). The median percent increase (positive numbers) or decrease from baseline is shown, along with the full range. |
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 | Percent Change in Fasting Triglyceride Levels | 5 years on metreleptin or last observation carried forward | Participants with immediate drop out, SAE withdrawal or death were excluded from analysis. | percentage of change from baseline | MEDIAN |
| SECONDARY | Percent Change in Hemoglobin A1c Levels | 5 years on metreleptin or last observation carried forward | Percent change in hemoglobin A1c levels (hemoglobin A1c levels are measured in %) Participants with immediate drop out, SAE withdrawal or death were excluded from analysis. | percentage of change from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Fasting Triglyceride Levels | Metreleptin | 55.76 | Full Range -66.79 to 203.80 | percentage of change from baseline | |
| Percent Change in Hemoglobin A1c Levels | Metreleptin | 2.55 | Full Range -27.52 to 25.00 | percentage of change from baseline |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metreleptin | 11 | |
| Overall Study | COMPLETED | Metreleptin | 4 | |
| Overall Study | NOT COMPLETED | Metreleptin | 7 |
Source ClinicalTrials.gov
Adverse events84
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 | worsening of chronic back pain | Musculoskeletal and connective tissue disorders | Metreleptin | 2 | 11 | 2 |
| other | hyperesthesia | Nervous system disorders | Metreleptin | 1 | 11 | 1 |
| other | sinus infection | Infections and infestations | Metreleptin | 1 | 11 | 1 |
| other | extremity weakness | Musculoskeletal and connective tissue disorders | Metreleptin | 2 | 11 | 2 |
| other | cold | Infections and infestations | Metreleptin | 3 | 11 | 3 |
| other | weight loss | Endocrine disorders | Metreleptin | 1 | 11 | 1 |
| other | elevated liver function tests | Metabolism and nutrition disorders | Metreleptin | 1 | 11 | 1 |
| other | acid reflux | Gastrointestinal disorders | Metreleptin | 1 | 11 | 1 |
| other | cellutitus | Infections and infestations | Metreleptin | 2 | 11 | 5 |
| other | kidney stone | Renal and urinary disorders | Metreleptin | 1 | 11 | 1 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metreleptin | 1 | 11 |
| Total, other adverse events | Metreleptin | 11 | 11 |
| Total, serious adverse events | Metreleptin | 8 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02654977
GET https://conductscience.org/api/trials/v1/NCT02654977/events?page=2