Actively Recruiting
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Led by Amryt Pharma · Updated on 2026-02-02
24
Participants Needed
7
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 13 years old at the time of signing informed consent
- Completed the APG-20 parent study and complied with study procedures through month 12
- Negative pregnancy test for female subjects of childbearing potential
- Female subjects must be postmenopausal, surgically sterile, or willing to use highly effective contraception with an additional barrier method during the study
- Male subjects must be surgically sterile or willing to use acceptable contraception during the study
- Willing to stop blood, egg, or sperm donations during the study and for 4 weeks after last treatment
- Able and willing to provide informed consent or assent, with parent or guardian consent if a minor
- Willing to follow dietary restrictions recommended by the Investigator
You will not qualify if you...
- Severe hypersensitivity reactions to the study treatment in the parent study APG-20
- Known positive for HIV or diagnosed with HIV-related lipodystrophy
- Immunocompromised or receiving immunomodulatory drugs
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2
- Clinically significant hematological abnormalities or blood cancers
- Ongoing or recent malignancy requiring treatment within the past year (except certain skin or in situ cancers)
- Currently pregnant or breastfeeding females
- Any condition that the Investigator believes poses significant risk for study participation
AI-Screening
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Trial Site Locations
Total: 7 locations
1
University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Flourish Research
Boca Raton, Florida, United States, 33434
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
University of Michigan
Ann Arbour, Michigan, United States, 48109
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
6
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
7
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
L
Lori Hartnett, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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