Dor Biopharma Announces Completion of Patient Enrollment in Phase II Trial of DR10624 for MASLD/MASH
Doer Biologics
Biological Drug Developer
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
DR10624-202 is a randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of DR10624 injection at four different dose levels (12.5 mg, 25 mg, 50 mg, 75 mg) in subjects with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk of liver fibrosis. The main inclusion criteria for this study include: liver fat content (LFC) ≥10% (measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF)); liver stiffness measurement (LSM) ≥8 Kpa and <15 Kpa (measured by FibroScan).®Evaluation). The first subject was enrolled in the DR10624-202 study in April 2025. A total of 110 MASLD/MASH subjects (including 103 subjects enrolled in mainland China and 7 subjects enrolled in Hong Kong, China) participated in this study, which involved once-weekly dosing for 12 consecutive weeks. Additionally, the clinical trial application for DR10624 injection for the treatment of MASLD in the United States was approved by the FDA in January 2026.
Huangyan Mountain
Founder and CEO of Doer Biologics
DR10624 is a first-in-class long-acting triple agonist targeting FGF21R, GCGR, and GLP-1R. DR10624 utilizes Doer Biologics' proprietary MultipleBody technology.®Platform technology development shows balanced activity against metabolic diseases. In non-clinical studies, DR10624 demonstrated significant dose-dependent efficacy in liver protection and anti-hyperlipidemia activity in B6-Alms1-del mice (a spontaneous MASH model characterized by obesity, hyperglycemia, and dyslipidemia). It also reduced steatosis, inflammation, and ballooning, and improved NAS scores, indicating that DR10624 has excellent therapeutic potential for MASLD/MASH.
Fang Yongliang
Chief Operating Officer of Doer Biologics
We are pleased to announce that the DR10624-202 study has successfully completed enrollment of all patients for the Phase II study in MASLD/MASH. The public health threat posed by MASLD/MASH is increasingly gaining attention. Patients with MASLD face a higher risk of cardiovascular disease, diabetes, and various metabolic disorders, while MASH represents a more severe form of MASLD and is a leading cause of liver failure globally. Without effective treatment, MASH can progress to cirrhosis, liver failure, or even liver cancer and death. The DR10624-202 study aims to identify the optimal dose of DR10624 for treating MASLD/MASH. We are committed to advancing DR10624 as a potential therapy for patients with these serious liver conditions. Topline data from this study is expected to be released in the third quarter of 2026.
For more information about the clinical trial of DR10624-202, please visit Clinicaltrials.gov (NCT07024212) or the Drug Clinical Trial Registry and Information Disclosure Platform (CTR20250525).
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