Immunogenicity of Metreleptin in Patients With Generalized Lipodystrophy
Completed · Phase 4 · NCT04026178
Conditions: Generalized Lipodystrophy
At a glance
- Research payments reported, 2025
- $39,996
- U.S. investigators named
- 4
- Sites paid
- 4
- Planned or actual enrollment
- 11
About the trial
- Sponsor
- Aegerion Pharmaceuticals, Inc.
- Tested
- Metreleptin (drug)
- Dates
- Started 2018-11-14; completion 2024-10-31
- Results posted
- Yes
MYALEPT™ (metreleptin) has been approved as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (MYALEPT Prescribing Information). This study is a multicenter, open-label, Phase 4 trial to provide an assessment of the immunogenicity associated with metreleptin and of any major potential risks due to development of antibodies to metreleptin. The study is being conducted to comply with a postmarketing requirement.
From ClinicalTrials.gov, last updated 2025-11-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Chiesi USA, Inc. reported $39,996 in research payments for this study in 2025 (11 payments).
Products named: Myalept
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Elif Oral, MD Endocrinology & Diabetes · Ann Arbor, MI
- Elena A. Christofides, MD, FACE Endocrinology & Diabetes · Columbus, OH
- Kathleen L. Wyne, M.D. Endocrinology & Diabetes · Columbus, OH
- Abhimanyu Garg, MD Endocrinology & Diabetes · Dallas, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The University of Texas Southwestern Medical Center $24,752
- Endocrinology Research Associates Inc $9,199
- The Ohio State University $4,095
- University of Michigan Health System, MI $1,950
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.