Long-Acting GLP-1/Glucagon Receptor Agonist Fast Tracked for MASH

The Food and Drug Administration (FDA) has granted Fast Track designation to DD01 for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH).

DD01 is a long-acting dual agonist of glucagon-like peptide-1 (GLP-1) and glucagon receptors. The designation was based on data from a randomized, double-blind, placebo-controlled phase 1 study (ClinicalTrials.gov Identifier: NCT04812262) that evaluated the efficacy and safety of DD01 in obese/overweight patients with type 2 diabetes and metabolic dysfunction-associated fatty liver disease. 

Study participants (n=50) were assigned to receive subcutaneous doses of DD01 (up to 80mg) or placebo once weekly for 4 weeks. Findings showed treatment with DD01 reduced hepatic steatosis by more than 50% and up to 100% of patients achieved at least 30% liver fat reduction based on MRI-proton density fat fraction. Improvements in glucose control and weight loss were also noted at higher DD01 doses.

“We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, PhD, CEO of D&D. “MASH has a significant unmet need. Multiple clinical trials have recently proven that efficiently reducing excessive liver fat content leads to ameliorating MASH and liver scarring. DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming phase 2.”