A South Korean biotech’s GLP-1 candidate has reduced liver fat in patients with metabolic dysfunction-associated steatohepatitis (MASH), with the added benefit of helping patients lose weight.
D&D Pharmatech tested a once-weekly regimen of its dual GLP-1/glucagon receptor agonist DD01 in 67 overweight or obese patients with MASH. A total of 75.8% of patients who received DD01 saw a more than 30% reduction in liver fat after 12 weeks compared to 11.8% of patients who received placebo, hitting the study’s primary endpoint.
Similar success was seen in the secondary endpoint of reducing liver fat by more than 50%, with 72.7% of the DD01 cohort achieving this compared to 5.9% of the placebo group. When it came to reducing liver fat by more than 70%, a total of 57.6% of DD01 patients were able to reach this endpoint compared to none of the placebo group, the biotech explained in a June 16 release.
The drug also showed “encouraging” weight loss potential, said D&D, which noted that 42.4% of patients who received the therapy saw a greater than 5% reduction in weight, while “placebo-treated subjects had no significant weight loss.”
Gastrointestinal side effects led three patients to discontinue treatment, although D&D said that, in general, these side effects were mild or moderate as well as being “transient and manageable.”
MASH—previously known as nonalcoholic steatohepatitis—has proven an elusive target for pharma, but several drugmakers are starting to find increasing success in the metabolic liver disease, including via GLP-1 routes. Novo Nordisk is awaiting an FDA decision on approving semaglutide, the ingredient in its blockbuster GLP-1 weight loss drug Wegovy, for MASH after it demonstrated improvements in liver fibrosis in a phase 3 trial.
There has also been promising MASH data from other GLP-1 drugs like Eli Lilly’s GIP/GLP-1 co-agonist tirzepatide and Boehringer Ingelheim’s glucagon/GLP-1 agonist survodutide.
D&D’s CEO Seulki Lee, Ph.D., said the results for DD01 this morning were “remarkably positive … after only 12 weeks.”
“The magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH,” Lee added. “Considering the combination of liver and metabolic benefits and the favorable tolerability profile, DD01 has the potential to provide patients and physicians with a MASH treatment that is easy to manage, encourages weight loss and is diabetes friendly.”