Skip to content

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518674-14-00
Acronym
R4461-MOB-2471
Enrollment
2
Registered
2025-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monogenic obesity

Brief summary

Percent change in Body Mass Index (BMI) from baseline to week 24.

Detailed description

Percent change in BMI from baseline to week 52., Absolute change in BMI from baseline, through week 52., Percent change in body weight from baseline, through week 52., Absolute change in body weight from baseline, through week 52., Change in waist circumference from baseline, through week 52 in participants aged ≥18 years., Change in absolute total fat mass by whole body DXA from baseline, through week 52., Change in percent total fat mass by whole body DXA from baseline, through week 52., Change in absolute regional fat mass by whole body DXA from baseline, through week 52., Change in percent regional fat mass by whole body DXA from baseline, through week 52., Change in scores in the symptoms of hyperphagia questionnaire from baseline, through week 52., Change in scores in the impacts of hyperphagia questionnaire from baseline, through week 52., Change in scores in the hunger questionnaire from baseline, through week 52., Number of treatment-emergent adverse events (TEAEs) through week 65., Severity of TEAEs through week 65., Concentrations of total mibavademab in serum through week 65., Incidence of anti-drug antibody (ADA) to mibavademab through week 65., Titer of ADA to mibavademab through week 65.

Interventions

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change in Body Mass Index (BMI) from baseline to week 24.

Secondary

MeasureTime frame
Percent change in BMI from baseline to week 52., Absolute change in BMI from baseline, through week 52., Percent change in body weight from baseline, through week 52., Absolute change in body weight from baseline, through week 52., Change in waist circumference from baseline, through week 52 in participants aged ≥18 years., Change in absolute total fat mass by whole body DXA from baseline, through week 52., Change in percent total fat mass by whole body DXA from baseline, through week 52., Change in absolute regional fat mass by whole body DXA from baseline, through week 52., Change in percent regional fat mass by whole body DXA from baseline, through week 52., Change in scores in the symptoms of hyperphagia questionnaire from baseline, through week 52., Change in scores in the impacts of hyperphagia questionnaire from baseline, through week 52., Change in scores in the hunger questionnaire from baseline, through week 52., Number of treatment-emergent adverse events (TEAEs) through wee

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026