SINGAPORE and SEOUL, South Korea, June 17, 2026
D&D Pharmatech and HistoIndex have announced encouraging new findings from an AI-powered analysis of liver biopsy samples collected during the Phase 2 clinical trial of zabopegdutide (DD01), an investigational therapy for Metabolic Dysfunction-Associated Steatohepatitis (MASH). The results demonstrated robust liver fibrosis improvement, further strengthening the therapeutic potential of zabopegdutide and highlighting the growing role of artificial intelligence-driven digital pathology in advancing clinical research for chronic liver diseases. The study utilized HistoIndex’s proprietary qFibrosis® platform, a fully quantitative fibrosis assessment technology designed to provide objective and reproducible measurements of treatment response beyond traditional pathology evaluations. The findings add significant momentum to the development of novel therapies aimed at addressing the increasing global burden of MASH and associated liver complications.
AI-Powered Analysis Confirms Significant Fibrosis Improvement
The independent analysis conducted by HistoIndex evaluated 48-week liver biopsy samples from patients enrolled in the Phase 2 trial. Researchers focused on protocol-compliant participants whose baseline fibrosis was confirmed as stage F1 or higher using qFibrosis®. The results showed that 81.8% of patients receiving zabopegdutide achieved at least a one-stage improvement in liver fibrosis, compared with only 18.8% in the placebo group, demonstrating a statistically significant treatment benefit.
In addition, quantitative fibrosis measurements revealed a 41.0% reduction in steatosis-corrected qFibrosis® scores among treated patients, while placebo recipients experienced a 9.5% increase, highlighting a substantial therapeutic advantage. These findings reinforce previously reported histological results and provide additional evidence that zabopegdutide can effectively reverse fibrosis progression while improving overall liver health.
Zabopegdutide Demonstrates Potential as a Differentiated MASH Therapy
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Zabopegdutide is a liver-targeted GLP-1/glucagon receptor agonist featuring an 11:1 GLP-1-to-glucagon potency ratio designed to deliver both metabolic and hepatic benefits while maintaining a favorable safety and tolerability profile. Earlier analyses from the Phase 2 study showed statistically significant improvements in MASH resolution, liver fat reduction, liver stiffness, body weight, and glycemic control after 48 weeks of treatment. The latest AI-driven assessment provides an additional layer of validation by quantitatively confirming fibrosis improvement observed through conventional pathology review.
According to D&D Pharmatech leadership, the integration of advanced digital pathology technologies strengthened confidence in the treatment effects and supports the continued development of zabopegdutide as a potentially differentiated therapy for patients with metabolic liver disease. The encouraging data position the drug candidate as a promising contender in the rapidly evolving MASH treatment landscape.
Digital Pathology Advances Precision in MASH Clinical Trials
The collaboration between HistoIndex and D&D Pharmatech underscores the increasing importance of AI-powered digital pathology in clinical drug development. Traditional histological scoring systems have long served as the gold standard for evaluating liver biopsies in MASH, but they can be limited in capturing the complexity and heterogeneity of fibrosis progression. Technologies such as qFibrosis® offer fully quantitative and highly sensitive measurements that improve the precision, reproducibility, and objectivity of treatment assessments.
Clinical experts involved in the study noted that AI-enabled fibrosis analysis may enhance the evaluation of therapeutic responses and accelerate the development of next-generation treatments for chronic liver diseases. Additional data from the study are expected to be presented at upcoming scientific conferences, further contributing to the growing body of evidence supporting AI-driven pathology solutions in pharmaceutical research and clinical development.
Source: D&D Pharmatech, HistoIndex press release
