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DR10624 in MASLD and MetALD
NCT07024212Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Apr 2025
- Primary completion
- Jun 2026
- Countries
- 2
- Sponsor
- Doer Bio
- Modality
- Fc-Fusion Proteins
- Drugs
- DR10624
- Conditions
- metabolic dysfunction-associated steatotic liver disease (MASLD)metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD)
01
Overview
Phase 2, randomised, double-blind trial of DR10624 in metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction and alcohol-associated steatotic liver disease (MetALD) (5 cohorts), sponsored by Doer Bio. Primary endpoint: Liver Fat Content at 12 weeks. Started Apr 2025; status: active, not recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Cohort 1
DR10624 injection/Placebo (SC, qw)
Cohort 2
DR10624 injection/Placebo (SC, qw)
Cohort 3
DR10624 injection/Placebo (SC, qw)
Cohort 4
DR10624 injection/Placebo (SC, qw)
Cohort 5
DR10624 injection/Placebo (SC, qw)
03
Who it enrols
Adults aged 18-75 with MASLD/MetALD, BMI 25-40, LFC >= 10%, and LSM 8-15 Kpa, excluding those with cirrhosis, type 1 diabetes, or recent malignancies.
04
Endpoints
Primary
Liver Fat Content
Secondary
Controlled Attenuation Parameter
Liver Stiffness Measurement
Relative reduction of Liver Fat Content
Liver Fat Content <5%
Liver Enzymes
Alanine Aminotransferase Reduction
Glucose metabolism-related parameters
Lipid profiles
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