Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Recruiting
Phase 3
Interventional Study
Familial Partial Lipodystrophy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 13 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
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About This Trial
This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥13 years of age, inclusive, at the time of signing the informed consent form (ICF).
2. Subjects must have completed the Parent study APG-20 and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures through Parent study Month 12 visit.…
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