[Edaily Reporter NA EUN-KYUNG ] D&D Pharmatech Inc.(347850)announced on the 21st that it has received the Clinical Study Report (CSR) for the U.S. Phase 2 clinical trial of Jabo Pegduotide. A CSR is the final official document that summarizes the design and conduct of a clinical trial, as well as the results of statistical analysis, in accordance with regulatory submission standards. It serves not only as supporting documentation for subsequent clinical trial applications but also as a reference for potential partners to evaluate the reliability of clinical data and the feasibility of development during technology transfer processes.

The efficacy and safety results included in this final results report were confirmed to be consistent with the primary endpoint data released last June and the 48-week biopsy results presented at the European Association for the Study of the Liver (EASL 2026) conference this May. Zabopegduotide TIDE not only met the primary endpoint evaluating hepatic fat reduction at Week 12 but also demonstrated resolution of MASH and improvement in liver fibrosis in the 48-week biopsy analysis.

The Phase 2 clinical trial was conducted as a randomized, double-blind, placebo-controlled study at 12 centers in the United States, involving 67 patients with metabolic and metabolic syndrome-associated liver disease (MASLD) and MASH who were overweight or obese. The primary endpoint was the “proportion of patients achieving a ≥30% reduction in intrahepatic fat at Week 12,” as measured by magnetic resonance imaging-based quantitative assessment of hepatic fat (MRI-PDFF).

The results showed that 75.8% of patients in the zabopegduotide group achieved a reduction in hepatic fat of 30% or more at Week 12, demonstrating statistical significance compared to the 11.8% in the placebo group (p<0.0001). The mean reduction in hepatic fat was 62.3% in the treatment group and 8.3% in the placebo group.

The company subsequently extended the clinical trial to Week 48 to evaluate histological changes via liver biopsy. The analysis included 35 patients out of 52 who had been diagnosed with MASH and F1–F3 liver fibrosis and who had completed both the baseline and Week 48 liver biopsies while fully adhering to the clinical trial protocol. Of these, 16 were in the 40 mg zabopegduotide treatment group and 19 were in the placebo group.

In the zabopegduotide TIDE group, 50.0% of patients achieved “fibrosis improvement without MASH progression,” which was 34.2 percentage points higher than the 15.8% observed in the placebo group (p=0.0323). The rate of “MASH resolution without fibrosis progression” was 62.5% in the treatment group and 5.3% in the placebo group (p=0.0003). The rate of “MASH resolution and fibrosis improvement”—which met both criteria simultaneously—also showed statistical significance at 37.5% and 5.3%, respectively (p=0.0192).

Improvements were also sustained through Week 48 based on non-invasive measures. Reductions in hepatic fat and improvements in liver stiffness were confirmed via magnetic resonance-based quantitative liver fat assessment and magnetic resonance elastography (MRE), respectively. Metabolic markers, including body weight, blood glucose, and blood lipids, also improved.

In the safety evaluation, the adverse events reported over the 48-week period were mostly mild or moderate transient gastrointestinal symptoms. A 2-week dose-escalation period was applied for Zabo Pegduotide. The company explained that, compared to some GLP-1 receptor agonists that employ dose-escalation periods of up to 20 weeks or more to reduce gastrointestinal adverse events, it observed a similar or lower treatment discontinuation rate even within this shorter timeframe.

Based on this final results report, D&D Pharmatech Inc. plans to continue its ongoing negotiations for the global technology transfer and strategic partnerships regarding Zabo Pegduotide.

Lee Seul-ki, CEO of D&D Pharmatech Inc., stated, “Securing the final results report confirms ZaboPegDutide’s efficacy in treating MASH through an official document, thereby strengthening the reliability and objectivity of the clinical results,” adding, “Based on the validated Phase 2 final data, we will be able to further accelerate the ongoing global technology transfer and strategic partnering negotiations.”