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New treatment option for Familial Partial Lipodystrophy
Official title Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
ClinicalTrials.gov ID: NCT06679270
What this study is testing
What is Metreleptin?
Metreleptin is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for familial partial lipodystrophy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 and older
You may be able to join if
- Age ≥13 years of age, inclusive, at the time of signing the informed consent form (ICF).
- people must have completed the Parent study APG-20 and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures...
- Negative pregnancy test (urine or serum) for female people of childbearing potential
- Female people must be postmenopausal (defined as cessation of menses for at least 1 year), surgically sterile (hysterectomy, bilateral oophorectomy...
- Male people must be surgically sterile or willing to use an acceptable method of contraception for the duration of the study (from the time they sign...
You likely can't join if
- Severe hypersensitivity reactions to the study treatment of the Parent study APG-20.
- Known to have tested positive for human immunodeficiency virus (HIV) or known to be diagnosed with HIV-related LD. Positive HIV test in countries...
- Are immunocompromised or receiving immunomodulatory drugs.
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for people...
- Diagnosis of clinically significant hematological abnormalities (including but not limited to clinically significant leukopenia, neutropenia, bone...
- Malignancy that is ongoing/not in remission or that currently requires or has required active treatment within the past year (with the exception of...
See the full eligibility criteria
- Age ≥13 years of age, inclusive, at the time of signing the informed consent form (ICF).
- people 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.
- Negative pregnancy test (urine or serum) for female people of childbearing potential
- Female people must be postmenopausal (defined as cessation of menses for at least 1 year), surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), or willing to use a highly effective method of...
- Male people must be surgically sterile or willing to use an acceptable method of contraception for the duration of the study (from the time they sign an ICF), until 4 weeks after the last dose of study treatment. An...
- people who are blood/egg/sperm donors should be willing to halt donations during the study and for 4 weeks following their last dose of study treatment.
- people who are willing to provide informed consent/assent prior to any study-specific procedures. If a minor, the subject has a parent or legal guardian able to read, understand, and sign the ICF and/or a Child Assent...
- people who are willing to follow the dietary restrictions recommended by the Investigator.
- Severe hypersensitivity reactions to the study treatment of the Parent study APG-20.
- Known to have tested positive for human immunodeficiency virus (HIV) or known to be diagnosed with HIV-related LD. Positive HIV test in countries requiring HIV testing.
- Are immunocompromised or receiving immunomodulatory drugs.
- Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) for people ≥18 years of age and by Bedside Schwartz for people \<18 years of age.
- Diagnosis of clinically significant hematological abnormalities (including but not limited to clinically significant leukopenia, neutropenia, bone marrow abnormalities, leukemia or lymphoma, or clinically significant...
- Malignancy that is ongoing/not in remission or that currently requires or has required active treatment within the past year (with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin...
- For females only: currently pregnant (confirmed with a positive pregnancy test) or breastfeeding.
- Any condition where, in the opinion of the Investigator, participation in this study may pose a significant risk to the subject.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Boca Raton, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbour, Michigan, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Boca Raton, Florida, United States; Boston, Massachusetts, United States; Ann Arbour, Michigan, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.