Who is eligible for clinical trial NCT05351164?

Participants must meet protocol criteria for Lipomatosis, Multiple Symmetrical. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05351164 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-06-10

Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL) (NCT05351164)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Michigan

🩺 Plain-English Summary (8th-Grade Level)

Participants (homozygous MFN2 \[gene that provides instructions to produce the Mitofusin 2 protein\] R707W) will be treated with Metreleptin, and effects on body composition, metabolic parameters and safety will be assessed over a 6 month intervention period. Additional safety will be assessed for 1 more year (up to 1.5 years total) in which adverse event data will be collected.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (13 items).

Location: University of Michigan — Ann Arbor, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Have the clinical diagnosis of MSL and being followed at University of Michigan (cohort to be studied in this proof-of-concept study is already available at Michigan).
Willing and able to tolerate the study procedures.
Willing and able to tolerate blood sampling.
Having no condition that may impede successful data collection or interfere with testing parameters.
\<60 years of age.
If female of childbearing potential:
Not breastfeeding.
Negative pregnancy test (human chorionic gonadotropin, beta subunit) at baseline.
Can read, understand and sign approved informed consent form, communicate with study physician, and study team, and understand and comply with protocol requirements.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Presence of advanced liver disease (abnormal synthetic function, prothrombin time \[PT\], or albumin) in medical records
Evidence of other etiologies of viral hepatitis in medical records
Presence of active hematologic, bone marrow or other abnormalities that may increase risk of bleeding in medical records.
Presence of HIV infection in medical records.
Presence of End-stage renal disease (ESRD), active cancer, or \>class 2 congestive heart failure based on medical history and physical examination.
Active chronic infection (e.g., known chronic osteomyelitis or Tuberculosis \[TB\]). May have transient infections but must be free of active infection for two weeks prior to study visits.
Unable to ambulate or tolerate trips to the University of Michigan Clinical Research Unit.
Clinically relevant Coronary artery disease (CAD): history of stent or Coronary artery bypass graft surgery (CABG) with cardiologist confirmed angina.
Presence of autoimmune disease.
Hypersensitivity to metreleptin.
General obesity not associated with congenital leptin deficiency.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Michigan — Ann Arbor, Michigan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗