Berberine Ursodeoxycholate Shows Promise in Type 2 Diabetes Treatment: JAMA

Key Findings

• The participants' mean age was 54.3 years and 63.7% were male.

• The mean HbA1c at baseline was 8.2%, BMI was 25.5, and FPG was 160.7 mg/dL.

• At week 12, HbA1c decrease was significant in both groups of HTD1801:

• 500 mg group: -0.4% (95% CI, -0.79% to -0.03%; p=0.04)

• 1000 mg group: -0.7% (95% CI, -1.10% to -0.35%; p<0.001)

FPG improved:

• 500 mg group: -13.0 mg/dL

• 1000 mg group: -18.4 mg/dL

• Lipid profiles and liver injury markers also improved in the 1000 mg group.

• HTD1801 was tolerable, as 97.3% of participants completed the study.

• There were mild adverse effects in 52.2% of subjects, but nobody stopped treatment due to side effects.

• There was a serious adverse event (retinal hemorrhage) in a single patient receiving 500 mg, but this was considered to be unrelated to the treatment.

This phase 2 trial showed that HTD1801 significantly reduces HbA1c and FPG levels, as well as liver and cardiometabolic markers, in T2D patients. The drug was well tolerated, with no significant safety issues. These results indicate that HTD1801 may provide a novel oral treatment for diabetes management beyond glycemic control. More studies are required to validate these advantages in larger populations.

Reference:

Ji L, Ma J, Ma Y, et al. Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(3):e2462185. doi:10.1001/jamanetworkopen.2024.62185