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.
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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.…
Contacts

Lori Hartnett, PhD

+3905212791

clinicaltrials_info@chiesi.com

CONTACT