D&D Pharmaceuticals, a South Korean clinical-stage biopharmaceutical company focused on developing medicines for metabolic, fibrotic, and neurodegenerative diseases, has recently published new data from its ongoing Phase II (NCT06410924) clinical trial of zabopegdutide (previously known as DD-01) for the treatment of F1–F3 metabolic dysfunction-associated steatohepatitis (MASH) and metabolic dysfunction-associated steatotic liver disease (MASLD) patients. The 12-week findings published on 22 July 2026, in the Lancet Gastroenterology & Hepatology were consistent with the 48-week data published in May (D&D, press release, 27 May 2026), and highlighted that zabopegdutide acts rapidly in treating MASH. Zabopegdutide is a pegylated dual receptor agonist targeting glucagon-like peptide-1 (GLP-1) and glucagon (GCG), a mechanism of action known to have effective metabolic efficacy in MASH and other metabolic conditions such as type 2 diabetes (T2D), with the recently published results bolstering the incretin agonism as an effective MASH treatment.
D&D Pharmaceuticals previously published its Phase II 48-week data in a press release. The trial enrolled a total of 67 patients in the US spanning F1–F3 MASH, 33 of whom were in the drug-treated group, and 34 of whom were assigned to the placebo group. The data showed that the drug was able to achieve MASH resolution in 62.5% of patients compared to 5.3% of patients in the placebo group, with around 50% of patients achieving a one-stage or greater fibrosis improvement with no worsening of MASH, compared to 15.8% of the placebo group. The recently published 12-week data reported that 30% of the patients experienced liver fat reductions compared to 12% in placebo—reinforcing the findings shared earlier this year and highlighting that the drug acts rapidly on the liver, independent of its weight-loss effect, making it a highly promising asset for both MASLD and MASH.
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Novo Nordisk currently leads the incretin agonist market in MASH with Wegovy (semaglutide), being the only incretin agonist in the 7MM approved specifically for this indication, having first launched in the US market in 2025. This gives Wegovy the first-to-market advantage, reinforced with extensive data from clinical trials in MASH and multiple other indications such as T2D. The competitive landscape is set to intensify further as several other incretin agonists advance through development for MASH, where according to GlobalData’s Drugs Database, there are currently five other incretin agonists being developed in the 7MM already in Phase III, with major players such as Eli Lilly with two of its assets (Mounjaro [tirzepatide] and retatrutide), as well as Boehringer Ingelheim’s survodutide, all expected to launch in the MASH market by 2035. Despite this crowding, the large number of drugs in development underscores the scale of the demand for these therapies. Many of these therapies are expected to see wide use, particularly in earlier-stage MASH (F1–F2). According to key opinion leaders (KOLs) previously interviewed by GlobalData, these agents may also be used in combination with other mechanisms in the pipeline, such as FGF21 mimetics and PPAR agonists. Based on KOL feedback, the latter classes tend to be more effective for fibrosis than for MASH resolution and are therefore likely to play a larger role in more advanced disease.
Taken together, the 12-week and 48-week datasets position zabopegdutide as one of the more compelling MASH assets in development, with its dual GLP-1/GCG mechanism delivering a rapid hepatic benefit that appears to act independently of weight loss, a distinction that could prove clinically meaningful to physicians as they aim to differentiate from the upcoming therapies in the pipeline. Still, D&D Pharmaceuticals will face steep competition from upcoming pipeline agents. zabopegdutide’s competitiveness and market positioning will entirely depend on a larger pivotal trial where longer-term durable response can be demonstrated in order to properly assess how it will perform and differentiate itself from the other incretin agonists already ahead in the race to market across the different stages of MASH (F1–F3).
