A Phase 3 trial evaluated HTD1801, a gut–liver anti-inflammatory metabolic modulator, in patients with type 2 diabetes inadequately controlled on metformin. The study presented results at the European Association for the Study of Diabetes 2025 Annual Meeting. 

Participants received either HTD1801 1000 mg twice daily or placebo for 24 weeks. At the end of the study, HTD1801 reduced HbA1c by an LS mean of −1.21%, compared with −0.68% in the placebo group, and 33% of patients achieved HbA1c below 7%, versus 11% with placebo. Improvements in blood sugar were accompanied by reductions in fasting and postprandial glucose, lipids, and inflammatory markers, suggesting broader cardiometabolic benefits.

The safety profile of HTD1801 was favorable, with adverse events reported in 75% of patients versus 68% with placebo and serious events occurring in 4% versus 6%. Only five cases of hypoglycemia were noted.
These findings highlight HTD1801 as a promising treatment option for type 2 diabetes patients who do not achieve glycemic targets with metformin alone, offering both glucose-lowering and metabolic benefits.