Trial · NCT05164341
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
NCT05164341, Phase 3, Completed, Chiesi Farmaceutici S.p.A.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL. Trials, record NCT05164341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05164341
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
- NCT number
- NCT05164341
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Partial Lipodystrophy
- Interventions
- metreleptin, Placebo
- First posted
- 2021-12-20
- Last updated
- 2026-11-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to month 6 in HbA1c in subjects with partial lipodystrophy (PL) | 6 months | To evaluate the efficacy (HbAa1c) of daily SC metreleptin treatment |
| Primary | Percent change from Baseline to month 6 in fasting TGs in subjects with partial lipodystrophy (PL) | 6 months | To evaluate the efficacy (TGs) of daily SC metreleptin treatment |
| Secondary | Safety analysis of AEs, AESIs, SAEs by treatment arm | 12 months | To evaluate the safety of daily SC metreleptin treatment in subjects with PL |
| Secondary | Change from baseline to months 9 and 12 in HbA1c in subjects with partial lipodystrophy (PL) | 12 months | To assess the effect of metreleptin on HbA1c |
| Secondary | Percent change from baseline to months 9 and 12 in fasting TGs in subjects with partial lipodystrophy (PL) | 12 months | To assess the effect of metreleptin on TGs |
| Secondary | Change from Baseline to each assessment time point in quality of life (QoL) in all subjects | 12 months | To assess the effect of metreleptin on quality of life (QoL) in all subjects |
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/NCT05164341
GET https://conductscience.org/api/trials/v1/NCT05164341/registered