D&D Pharmatech’s GLP-1/glucagon dual agonist hits primary endpoint in MASH phase 2 

D&D Pharmatech said Monday that its GLP-1/glucagon dual agonist DD01 met the primary endpoint in a U.S. phase 2 study in patients with metabolic dysfunction-associated steatohepatitis (MASH), a chronic progressive disease marked by fat buildup in the liver, showing a statistically significant reduction in liver fat after 12 weeks of treatment.

According to the company’s regulatory filing, 75.8 percent of patients treated with DD01 saw at least a 30 percent reduction in liver fat as measured by MRI-PDFF, a quantitative imaging biomarker widely used to assess liver fat content, compared to 11.8 percent with placebo (p < 0.0001).

Average liver fat reduction was 62.3 percent with DD01 versus 8.3 percent with placebo. Among patients who completed the full protocol and imaging, the responder rate rose to 85.7 percent, with a mean reduction of 67.3 percent.

Mazen Noureddin, principal investigator and founding director of the Fatty Liver Program at Cedars-Sinai, said the consistent improvement in liver stiffness on MRE “further supports the biological activity of this GLP-1/glucagon mechanism,” which is designed for direct liver action.

The results, he added, suggest DD01 could meet both steatohepatitis resolution and fibrosis improvement endpoints required by the FDA.

The double-blind, placebo-controlled trial enrolled 67 overweight or obese patients (BMI ≥ 25 kg/m²) with MASLD/MASH across 12 sites in the U.S. Participants were randomized to receive weekly subcutaneous injections of DD01 or placebo for 48 weeks. 

The interim analysis is based on 12-week MRI-PDFF data, with secondary endpoints including safety, tolerability, metabolic biomarkers, and liver histology to be assessed through week 48.

DD01’s efficacy appears comparable to Boehringer Ingelheim’s survodutide, another GLP-1/glucagon dual agonist, which showed a 76.9 percent responder rate and 64.3 percent mean fat reduction after 48 weeks in its phase 2 study.

D&D said DD01 reached similar levels after just 12 weeks of dosing.

In addition to the primary endpoint, D&D reported that 72.7 percent of patients on DD01 achieved at least a 50 percent reduction in liver fat, while 57.6 percent reached 70 percent or more. The company said 48.5 percent of patients normalized liver fat content to 5 percent or less by week 12.

Three patients, or 9.1 percent of those on DD01, discontinued due to gastrointestinal side effects. Still, the company noted that DD01 used a rapid two-week dose escalation and “showed a lower discontinuation rate than survodutide,” which took 24 weeks to titrate. That profile, D&D said, points to “not only competitive efficacy but also a superior safety profile.”

The company also reported statistically significant improvements in non-invasive fibrosis markers, body weight, and glycemic control compared to placebo. About 42.4 percent of patients on DD01 lost more than 5 percent of their body weight during the 12-week period.

Final data from the 48-week study, including liver biopsy-based assessments of steatohepatitis resolution and fibrosis improvement, are expected in the first half of 2026. D&D said the full clinical study report is planned for the third quarter of 2026.

D&D Pharmatech CEO Lee Seul-ki said the company will pursue partnerships and licensing opportunities based on the interim results. Detailed data will be shared at an investor briefing and presented at a major U.S. medical congress in the second half of 2025.