D&D Pharmatech, a GLP-1 drug developer, said Friday it has completed week 12 dosing of all patients in its U.S. phase 2 clinical trial of DD01, a drug for metabolic-associated steatohepatitis (MASH).

The company is analyzing key data, including the primary endpoint, MRI-PDFF, and will release the results by June.

DD01 is D&D Pharmatech's proprietary long-acting dual-agonist pipeline that simultaneously targets the GLP-1 and glucagon receptors. In a phase 1 study in the U.S., DD01 was dosed for four weeks in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), accompanying obesity and type 2 diabetes, and demonstrated an average reduction in liver fat of 52.2 percent in the high dose group.

Based on these results, the phase 2 study was designed as a randomized, double-blind, placebo-controlled study in 67 overweight/obese patients with a BMI ≥25 kg/m² with MASLD/MASH at 12 clinical sites in the U.S.

The primary endpoint will be assessed using MRI-PDFF at week 12 of the 48-week treatment period to determine the proportion of patients with at least a 30 percent reduction in liver fat, and at week 48, tissue biopsies will be taken to confirm resolution of MASH and improvement in fibrosis, providing key data for FDA approval.

D&D Pharmatech completed patient recruitment in the trial in January. Results from the primary endpoint are expected in mid-June, subject to completion of week 12 dosing for all patients.

"The clinical trial to date has confirmed a superior safety profile compared to competing drugs, and the recently obtained blinded data on fatty liver reduction showed a high proportion of patients with significant liver fat reduction, raising expectations for the results to be announced in June," said Lee Seul-ki, CEO of D&D Pharmatech.