Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial.
Summary
In a 12-week, phase 2 double-blind RCT (n=113), HTD1801 reduced HbA1c dose-dependently versus placebo (−0.4% and −0.7% for 500 mg and 1000 mg b.i.d.) and improved fasting glucose, lipids, and liver injury markers (at 1000 mg). The regimen was well tolerated with high completion rates.
Key Findings
- Dose-dependent HbA1c reductions at 12 weeks vs placebo: −0.4% (500 mg) and −0.7% (1000 mg).
- FPG improved in both HTD1801 groups; lipid and liver injury markers improved in the 1000 mg group.
- Safety and tolerability were favorable with a 97.3% completion rate and mostly mild adverse events.
Clinical Implications
HTD1801 may become an oral option for patients with T2D needing concurrent improvements in glycemia, liver injury markers, and lipids pending phase 3 confirmation.
Why It Matters
First-in-class gut–liver anti-inflammatory modulator demonstrating glycemic and extra-glycemic benefits in T2D, aligning with the need for therapies addressing cardiometabolic comorbidities.
Limitations
- Short duration (12 weeks) and modest sample size; conducted in a single country
- Not powered for hard cardiometabolic outcomes; longer-term safety/efficacy pending
Future Directions
Phase 3 trials to confirm durability and breadth of benefits, define target populations, and assess effects on NASH/MASH-related endpoints and cardiovascular risk.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- II - Phase 2 double-blind randomized controlled trial
- Study Design
- OTHER