Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05351164 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 2
Started2023-08-01
View on ClinicalTrials.gov ↗

Amendment history

2025-06-10
Study Status, Outcome Measures (Results) v7
Results first postednot stated→2025-06-12
2025-04-07
Study Status, Study Description, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v6
Primary endpoints2 entries, revised
Change in totalTotal adiposityAdiposity Change in truncalTruncal adiposityAdiposity
2025-03-07
Study Status, Study Description v5
Completion date2025-04→2028-10
Study description+138 characters
In 2024, the IRB granted an amendment that allowed for continued data collection, including adverse events, up to 5 years per participant.
2024-04-17
Enrolling by Invitation→Active, Not Recruiting Study Status, Study Description, Study Design v4
Trial statusEnrolling by Invitation→Active, Not Recruiting
PhasePhase 1→Phase 2
Primary completion dateestimated 2024-03→confirmed 2024-04-08
Completion date2024-06→2025-04
Enrollment targetestimated 2→confirmed 4
2023-11-15
Study Status v3
Primary completion date2023-12→2024-03
Completion date2023-12→2024-06
Start dateestimated 2023-05→confirmed 2023-08-01
Show 2 earlier versions
2023-04-06
Study Status v2
Start date2023-03→2023-05
2023-02-10
Not Yet Recruiting→Enrolling by Invitation Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Primary completion date2022-10→2023-12
Completion date2022-10→2023-12
Start date2022-07-28→2023-03
Study sitescontacts updated at 1 of 1 site
2022-04-22
Original filing
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.
Trial Details
NCT Number NCT05351164
Lead Sponsor University of Michigan
Collaborators: Amryt Pharma
Conditions Lipomatosis, Multiple Symmetrical
Enrollment 4 participants
Start Date 2023-08-01
Primary Completion 2024-04-08 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2025-06-12