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NCT05351164 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)
A Phase 2 study of Lipomatosis, Multiple Symmetrical, sponsored by University of Michigan.
- Active
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT05351164: Active Phase 2 study of Lipomatosis, Multiple Symmetrical, sponsored by University of Michigan.
NCT05351164 is a Phase 2 study of Lipomatosis, Multiple Symmetrical that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05351164, a Phase 2 study of Lipomatosis, Multiple Symmetrical, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
A dual-energy X-ray absorptiometry (DEXA) scan was used to measure truncal adiposity at baseline and week 24. Truncal adiposity is the amount of fat a person has in the trunk area, and this outcome measure looked at the change in the fat in this area of the body in relation to the total fat in the participant's body. Results represent the change in the percentage of fat tissue from the trunk area to the total body.
Conditions Studied
Interventions
- DRUG Metreleptin
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-08-01 |
| Est. Completion | 2028-10 |
| Phase | Phase 2 |
What the registry record for NCT05351164 still lists
NCT05351164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lipomatosis, Multiple Symmetrical appearing as the primary indexed condition, and to 1 intervention - of which Metreleptin is the first listed.
NCT05351164 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05351164 about?
NCT05351164 is a clinical study titled "Evaluation of Safety and Efficiency of Metreleptin Treatment for Patients With Multiple Symmetric Lipomatosis (MSL)". 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...
What is the current status of trial NCT05351164?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2023-08-01. Estimated completion is 2028-10.
What conditions does trial NCT05351164 study?
This clinical trial studies the following conditions: Lipomatosis, Multiple Symmetrical.
What interventions are being tested in trial NCT05351164?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT05351164?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05351164 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05351164's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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