A randomised, double-blind, placebo-controlled phase 2 trial evaluated once-weekly subcutaneous DD01 40 mg (a liver-targeted GLP-1/glucagon dual agonist) vs. placebo over 12 weeks in 67 adults (BMI ≥25 kg/m²) with MASLD or biopsy-confirmed MASH, with a primary endpoint of ≥30% relative reduction in liver fat by MRI-PDFF.
At week 12, 76% (25/33) of DD01 recipients achieved ≥30% liver fat reduction vs. 12% (4/34) on placebo (adjusted OR 28.8 [95% CI 7.2–115.2]; adjusted RR 6.3 [95% CI 2.5–15.9]; p<0.0001). Nausea (55% vs. 18%), vomiting (30% vs. 12%), and diarrhoea (27% vs. 18%) were the most common adverse events. Two serious adverse events (abdominal pain, acute cholecystitis) occurred in the DD01 group; no deaths.
- Short 12-week window limits conclusions on histologic endpoints (fibrosis, MASH resolution) and durability. - Small sample (n=67) reduces power to detect rare safety signals. - Study population was 85% White, limiting generalisability.
DD01 produced rapid, large reductions in liver fat at 12 weeks, but this is an interim analysis of an ongoing 48-week trial — histologic and long-term outcomes are not yet available. Clinicians should await full trial results before considering DD01 alongside established MASLD/MASH therapies.
