HighTide Therapeutics Presents Analyses of a Phase 2 T2DM Study at the ADA Scientific Sessions, Highlighting Glycemic and Cardiometabolic Benefits of Berberine Ursodeoxycholate (HTD1801)
Based on the successful Phase 2 study, two Phase 3 studies (NCT06350890, NCT06353347) are currently ongoing to further evaluate the efficacy and safety of HTD1801 (as monotherapy and as add-on to metformin) in patients with T2DM and inadequate control. "We look forward to the results of our pivotal T2DM program which we expect to announce in the first half of 2025," said Dr.
"Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters Across the T2DM Disease Spectrum" (Abstract 847-P, Poster Presented
About the Abstract:
In a Phase 2, placebo-controlled, double-blind study in patients with T2DM, treatment with HTD1801 for 12 weeks resulted in significant dose-dependent improvements in key glycemic parameters. The objective of this post-hoc analysis was to evaluate the effectiveness of HTD1801 in patients with T2DM across the disease spectrum based on baseline HbA1c, with a particular emphasis on glycemic and lipid metabolism markers, along with indicators of liver injury. These data show that regardless of baseline disease severity, HTD1801 treatment resulted in significant improvements across these key parameters. The magnitude of improvement was greater in those with more severe disease. HTD1801 may offer a unique therapeutic approach for individuals with T2DM and other comorbidities (i.e. MASH and dyslipidemia), as managing these conditions effectively is crucial in controlling T2DM and reducing its associated complications.
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