D&D Pharmatech has reached a significant milestone in its clinical development program with the completion of patient enrollment for its Phase 2 trial evaluating DD01, a novel long-acting dual GLP-1/glucagon receptor agonist, in the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The randomized, double-blind, placebo-controlled trial will evaluate DD01's efficacy and safety over 48 weeks in overweight and obese patients with biopsy-confirmed MASH. The study will administer 40 mg of DD01 weekly, with a primary focus on measuring changes in liver fat content via MRI-PDFF at the 12-week mark.
Promising Early Clinical Evidence
DD01 has already shown encouraging results in earlier studies. In a proof-of-concept trial involving overweight/obese patients with Type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD), both 40 mg and 80 mg doses demonstrated remarkable efficacy. After just 4 weeks of treatment, patients experienced:
- Mean relative reduction of >50% in liver fat content
- Decreased HbA1c levels
- Reduced liver AST/ALT levels
- Lower serum lipids
- Modest weight loss
A key advantage of DD01 is its rapid onset of action without requiring the lengthy titration period typically associated with other MASH treatments. This characteristic could potentially offer a significant benefit for both patients and healthcare providers.
Study Design and Endpoints
The Phase 2 trial, identified as DD01-DN-2, incorporates several key endpoints:
- Primary assessment of MRI-PDFF changes at 12 weeks
- MASH resolution evaluation at 48 weeks
- Fibrosis improvement assessment
- Changes in HbA1c levels
- Body weight modifications
"Based on clinical and preclinical studies completed to date, we expect this study to confirm best-in-class potential for DD01 in MASH with long-term treatment," stated Seulki Lee, Ph.D., President and CEO of D&D Pharmatech. He emphasized the drug's three key beneficial effects: "rapid and robust reductions in liver fat, glucose control, and weight loss leading to clinically significant rates of MASH resolution and fibrosis improvement."
Unique Mechanism of Action
DD01's distinctive dual pathway mechanism sets it apart from other treatments. Unlike single-pathway agents, DD01 acts as both a GLP-1 and glucagon receptor agonist, enabling targeted and rapid reductions in liver fat. The drug maintains a substantial half-life of 7-8 days in the target patient population.
The FDA has recognized DD01's potential by granting it Fast Track designation for MASH treatment in adults. Top-line results from the 12-week efficacy and safety assessments are anticipated in late Q2 2025, with the trial being tracked under the identifier NCT06410924.
