Trial · NCT06679270
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
NCT06679270, Phase 3, Recruiting, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy. Trials, record NCT06679270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06679270
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
- NCT number
- NCT06679270
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Familial Partial Lipodystrophy
- Interventions
- Metreleptin
- First posted
- 2024-11-07
- Last updated
- 2026-07-16
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the Incidence and Frequency of Treatment-Emergent Adverse Events (Safety and Tolerability) | From enrollment to the end of treatment (until the last participant completes 24 months) | Incidence and frequency of treatment-emergent adverse events (TEAEs) including serious adverse events (SAEs), treatment-related TEAEs, adverse events of special interest (AESI), and adverse events leading to study treatment discontinuation/withdrawal from the study |
| Secondary | To evaluate the long-term efficacy (HbA1c) of daily SC metreleptin treatment in participants with familial partial lipodystrophy (FPLD) | From enrollment to the end of treatment (until the last participant completes 24 months) | Glycated hemoglobin (HbA1c) in participants with HbA1c ≥7% at the Parent study Baseline, over time during the OLE |
| Secondary | To evaluate the long-term efficacy (TGs) of daily SC metreleptin treatment in participants with FPLD | From enrollment to the end of treatment (until the last participant completes 24 months) | \- Fasting triglycerides (TGs) in participants with TG ≥500 mg/dL at the Parent study Baseline, over time during the OLE |
| Secondary | To evaluate the long-term efficacy (FBG) of daily SC metreleptin treatment in participants with FPLD | From enrollment to the end of treatment (until the last participant completes 24 months) | * Fasting blood glucose (FBG) in participants with HbA1c ≥7% at the Parent study Baseline, over time during the OLE * FBG in participants with FBG above upper limit of normal (ULN) at the Parent study Baseline, over time during the OLE |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06679270
GET https://conductscience.org/api/trials/v1/NCT06679270/registered