847-P: Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters across the Type 2 Diabetes Mellitus Disease Spectrum

Introduction: HTD1801 is a gut-liver anti-inflammatory metabolic modulator shown to improve key glycemic and cardiometabolic parameters. The aim of this study was to evaluate the effectiveness of HTD1801 across the T2DM disease spectrum.

Method: In a Ph2 study of treatment-naïve patients with T2DM 113 patients were randomized 1:1:1 to placebo (n=38), HTD1801 500 mg BID (n=37), and 1000 mg BID (n=38) for 12 weeks. Key inclusion criteria included T2DM (WHO criteria), HbA1c 7%-10.5% and FPG <13.9 mmol/L. The primary endpoint was change from baseline (BL) in HbA1c at Week 12. For this analysis, patients were assigned to high/low risk groups by BL HbA1c above/below 8.5%.

Result: At BL, 35% of patients had HbA1c ≥8.5%. BL characteristics were balanced between treatment groups and subgroups. Patients with elevated HbA1c had elevated glycemic and cardiometabolic parameters at BL. Treatment with HTD1801 for 12 weeks resulted in a dose dependent reduction across both subgroups (Table). Improvements with 1000 mg BID were significant vs placebo at Week 12. HTD1801 patients with higher HbA1c had more substantial reductions across all parameters compared to patients with lower HbA1c.

Conclusion: Regardless of BL disease severity, HTD1801 treatment resulted in significant improvements in key glycemic and cardiometabolic parameters. HTD1801 continues to be evaluated for T2DM in Ph3 studies.

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