DD-01 Advanced Drug Monograph

Medication Report: DD-01

Name: DD-01 Name (English): DD-01

Developer: D&D Pharmatech Mechanism of Action: Dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors. Modality: Peptide/Protein Route of Administration: Injection Half-life: 7-8 days (in obese/overweight patients with T2D and MASLD)

Current Development Phase: Phase 2 Highest Development Phases:

• Phase II: Metabolic dysfunction-associated steatohepatitis (MASH) / Nonalcoholic steatohepatitis (NASH), Obesity
• Phase I: Type 2 Diabetes Mellitus, Metabolic dysfunction-associated steatotic liver disease (MASLD)

Indication:

• Metabolic dysfunction-associated steatohepatitis (MASH) / Nonalcoholic steatohepatitis (NASH)
• Obesity
• Type 2 Diabetes Mellitus
• Metabolic dysfunction-associated steatotic liver disease (MASLD)

Clinical Trial Status: Active, not recruiting (Phase 2 trial in MASH)

Description: DD-01 is a proprietary, once-weekly dual agonist of GLP-1 and glucagon receptors. It is liver-targeted and has shown in studies to rapidly reduce hepatic steatosis, improve glycemic control, and reduce body weight. Unlike some other treatments for MASH, DD-01 does not require lengthy titration to reach therapeutic levels.

Key Findings from Studies:

• In a Phase 1 study, DD-01 was well-tolerated in overweight/obese patients with Type 2 diabetes and MASLD.
• Following 4 weeks of treatment (40 mg and 80 mg doses), it resulted in a mean relative reduction of >50% liver fat content by MRI-PDFF.
• Improvements were observed in HbA1c, liver enzymes (AST/ALT), serum lipids, and modest weight loss.
• Preclinical studies in obese mice and monkeys showed DD-01 to be more effective than diet or GLP-1 treatment alone in reducing liver fat and weight.

Regulatory Status: FDA Fast Track designation for the treatment of adults with MASH.

Latest News:

• Patient enrollment completed for a 48-week Phase 2 trial evaluating the effectiveness of DD-01 in the treatment of MASH (February 2025).
• Initiation of dosing in a Phase 2 trial in overweight/obese subjects with MASLD/MASH (August 2024).
• FDA granted Fast Track designation for the treatment of NASH/MASH (April 2024).

Note: Top-line 12-week efficacy and safety results from the Phase 2 MASH trial are expected in late Q2 2025.