Obesity and metabolic disease new drug corporations D&D Pharmatech said on the 27th that in the United States it met all key histological endpoints in phase 2 of its investigational new drug candidate for metabolic dysfunction–associated steatohepatitis (MASH), "Zabopegdutide (DD01)."
It simultaneously demonstrated improvement in liver fibrosis and resolution of MASH, and on the news, expectations for technology transfer grew, sending the company's stock to the intraday upper limit.
D&D Pharmatech is participating in the European Association for the Study of the Liver Congress 2026 (EASL Congress 2026), held in Barcelona, Spain, from today through the 30th, and disclosed the 48-week liver biopsy results from the DD01 phase 2 trial.
DD01 is a dual-acting drug that simultaneously targets the glucagon-like peptide-1 (GLP-1) and glucagon receptors.
MASH is a disease previously called nonalcoholic steatohepatitis (NASH). The condition occurs when toxic lipid molecules accumulate in the liver and, over time, cause inflammation and tissue damage. Twenty percent of patients develop cirrhosis, and in severe cases it can lead to liver cancer.
The company said the trial achieved statistical significance across the histological endpoints considered central to developing MASH treatments.
The trial was conducted at 12 sites in the United States in a randomized, double-blind, placebo-controlled design. Sixty-seven overweight or obese patients with a body mass index (BMI) of at least 25 kg/㎡ participated. Among patients with biopsy-confirmed MASH and liver fibrosis (F1–F3) who completed both baseline and week-48 biopsies, efficacy was analyzed in 35 people (19 on placebo, 16 on DD01).
As a result, first, on the "liver fibrosis improvement" endpoint that the U.S. Food and Drug Administration (FDA) regards as critical in approving MASH therapies, half (50%) of patients treated with DD01 showed improvement. The improvement rate in the placebo group was 15.8%. Put simply, about one in two patients on DD01 saw an improvement in liver scarring (fibrosis).
Another key endpoint, "MASH resolution," was also clear. In 62.5% of the DD01 group, liver inflammation and fat accumulation improved, resulting in MASH resolution. By contrast, only 5.3% in the placebo group showed the same effect. The company said, "Both endpoints delivered statistically meaningful results."
Notably, the proportion of patients who achieved both MASH resolution and a reduction in liver scarring (fibrosis improvement) reached 37.5% in the DD01 group, far higher than in the placebo group (5.3%). The company said this means it not only lowered fatty liver metrics but improved both the disease itself and liver damage.
As obesity drug classes expand into the MASH field, D&D Pharmatech is being credited with demonstrating differentiation through biopsy-based data.
The company said that even with only a two-week dose-escalation period, DD01 showed a treatment discontinuation rate similar to other GLP-1 class therapies that gradually escalate doses over more than 20 weeks.
Improvements were also confirmed in noninvasive markers. The company said the improvements seen at week 12 in MRI-PDFF, which measures liver fat content, and MRE, which assesses liver stiffness, were maintained through week 48. Safety also appeared favorable. The most common adverse events were gastrointestinal symptoms, and most were mild or moderate.
The results are also heightening expectations for global technology transfer. Currently, the only MASH therapy approved by the U.S. FDA is "Rezdiffra," approved in 2024 from Madrigal Pharmaceuticals. With the market in its early stage, competition among major drugmakers to secure pipelines is fierce.
In fact, GSK plc acquired Boston Pharmaceuticals for about $2 billion, and Switzerland's Roche acquired 89bio in a $3.5 billion deal. Novo Nordisk committed $5.2 billion to acquire Akero Therapeutics.
D&D Pharmatech has signed a consulting agreement with major U.S. investment banks (IB) and is in discussions with global pharmaceutical companies for technology transfer and strategic partnering. The company said, "These clinical results will accelerate global discussions."
Mazen Noureddin, who led the trial, said, "It is very encouraging that in less than a year at least a one-stage improvement in liver fibrosis was confirmed in half of the patients," adding, "Given the strong safety profile, it has the potential to become a next-generation treatment option for metabolic liver disease."
Chief Executive Lee Seul-gi of D&D Pharmatech said, "Despite a relatively limited number of patients, we confirmed differentiated histological improvements," and added, "Based on these data, we will actively accelerate global partnering discussions."