Final 48-week clinical results presented in a late-breaking oral session at the premier American Association for the Study of Liver Diseases (AASLD The Liver Meeting 2026).
Demonstrated comprehensive improvements in metabolic indicators including fatty liver, liver enzymes, body weight, and blood glucose, alongside histological liver biopsy results like fibrosis improvement.
Accelerated out-licensing discussions anticipated through in-person meetings with global pharmaceutical partners during the conference.
D&D Pharmatech announced that its metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate, Zabopegdutide (development code: DD01), met primary endpoints in the final 48-week analysis of its Phase 2 clinical trial, demonstrating significant MASH resolution and liver fibrosis improvement compared to a placebo.
D&D Pharmatech CEO Lee Seul-ki announced on the 9th that the company presented the final Phase 2 results for Zabopegdutide during the Late-Breaking Abstract (LBA) oral presentation session at the AASLD annual meeting, The Liver Meeting 2026, held on the afternoon of the 8th local time.
According to the company, the Zabopegdutide treatment group showed statistically significant improvements compared to the placebo group across all core histological evaluation metrics outlined in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines.
The rate of achieving "MASH resolution without worsening of fibrosis" was 62.5% in the treatment group compared to 5.3% in the placebo group (p<0.001). The rate of achieving "fibrosis improvement without worsening of MASH" reached 50.0% for the treatment group versus 15.8% for the placebo group (p=0.03). The composite response rate meeting both criteria simultaneously was 37.5% for the treatment group, significantly outperforming the 5.3% observed in the placebo group (p=0.02).
In addition to traditional qualitative pathologist readings, the study incorporated analyses using digital pathology AI company HistoIndex's machine learning algorithm, qFibrosis®. Steatosis-corrected analysis revealed that 81.8% of patients in the treatment group achieved an improvement in fibrosis of at least one stage. The continuous fibrosis score decreased by 50.5% after adjusting for the placebo group. The company noted that these AI-driven evaluations reinforced the objectivity and reliability of the clinical data.
Non-invasive diagnostics (NIT) also exhibited positive trends. Magnetic resonance elastography (MRE), along with liver fibrosis blood markers ELF score and PRO-C3, showed consistent improvements, while liver injury enzymes ALT and AST decreased significantly compared to the placebo group. Reductions in body weight, visceral adipose tissue (VAT), and glycated hemoglobin (HbA1c) levels were also observed. The company stated these findings confirm the drug's potential as a comprehensive therapeutic agent addressing not only liver fibrosis but also broader metabolic disorders.
Regarding safety, patients underwent a two-week dose-escalation phase, and treatment-emergent adverse events were predominantly mild to moderate, such as nausea and vomiting. Researchers evaluated these efficacy and safety profiles as robust clinical and academic foundations for advancing into late-stage clinical development.
The presentation was led by Professor Mazen Noureddin, principal investigator (PI) of the Zabopegdutide Phase 2 clinical trial, following his presentation last year. Professor Noureddin focused on the histological therapeutic efficacy confirmed via liver biopsies after 48 weeks of administration, building upon the 12-week fatty liver improvement data.
AASLD, alongside the European Association for the Study of the Liver (EASL), is a premier global conference where liver disease specialists and biopharmaceutical companies share cutting-edge clinical research. Following its selection as an LBA at AASLD 2025 to present 12-week results including primary endpoints, D&D Pharmatech achieved a consecutive two-year presentation milestone this year with research abstracts featuring 48-week liver biopsy data.
On-site at the conference, D&D Pharmatech held in-person meetings with multinational pharmaceutical companies, continuing discussions with existing global big pharma and corporate partners. The company expects the disclosure of the final 48-week histological efficacy and safety results to accelerate ongoing global out-licensing negotiations.
"It is highly meaningful to present the clinical data for Zabopegdutide to the global community for the second consecutive year through an oral presentation at the world's most prestigious AASLD conference," said D&D Pharmatech CEO Lee Seul-ki. "As global partners currently in discussions have also evaluated the therapeutic potential of Zabopegdutide very positively, we will focus our capabilities on successfully finalizing licensing agreements based on these results."/>
