Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amryt Pharma
Study ID
NCT06679270
Phase
PHASE3
Status
Recruiting
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Conditions

  • Familial Partial Lipodystrophy

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metreleptin — DRUG
    Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency

Study Details

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

Key Dates

Start date
Oct 14, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metreleptin
    Metreleptin \[Recombinant-methionyl human Leptin; r-metHuLeptin\] for daily injection is a sterile, white, solid lyophilised cake

Primary Outcome Measure

Evaluate the Incidence and Frequency of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: From enrollment to the end of treatment (until the last participant completes 24 months) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233
Fernando Ovalle
Fernando Ovalle (PRINCIPAL_INVESTIGATOR)
Flourish ResearchBoca RatonFlorida33434
Rasha Youssef
Rasha Youssef (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Lindsay Fourman, MD
Lindsay Fourman, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArbourMichigan48109
Elif Oral, MD
Elif Oral, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Vaneeta Bamba, MD
Vaneeta Bamba, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Abhimanyu Garg, MD
Abhimanyu Garg, MD (PRINCIPAL_INVESTIGATOR)
The Medical College of WisconsinMilwaukeeWisconsin53226
Bradley Javorsky, MD
Bradley Javorsky, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALFlourish Research· Boca Raton, FLMassachusetts General Hospital· Boston, MAUniversity of Michigan· Ann Arbour, MIChildren's Hospital of Philadelphia· Philadelphia, PAUT Southwestern Medical Center· Dallas, TX