Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
← catalyst calendarNCT07220785 · readout in 639 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
28estimated
Sites
5
Countries
Brazil, France, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-13 | actual | When the study began enrolling |
| Primary completion | 2028-05-19 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-09-08 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Generalized Lipodystrophy
Interventions
- Drug: Mibavademab — also filed as REGN4461
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFChange in Hemoglobin A1c (HbA1c)
measured Through 36 weeks of exposure to mibavademab
Percent change in fasting Triglycerides (TG)
measured Through 36 weeks of exposure to mibavademab
Occurrence of Treatment Emergent Adverse Events (TEAEs)
measured Up to 15 months
Severity of TEAEs
measured Up to 15 months
Concentrations of total mibavademab in serum
measured Up to 15 months
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