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A phase 3 trial finds that HTD1801 — a combo of berberine and ursodeoxycholate rooted in traditional Chinese medicine — significantly cut A1c levels when added to metformin in T2D patients. The drug also improved LDL cholesterol and oxidative stress markers, with no severe hypoglycemia reported. Researchers say it could be a cost-effective, multi-targeted option for the roughly one-third of patients who don't respond adequately to metformin alone.
A centuries-old remedy gets a modern clinical trial — and delivers.
HTD1801, an oral combination of berberine (a plant compound used in Chinese medicine for over 1,000 years) and ursodeoxycholate (a bile acid approved for liver disease), significantly reduced A1c levels in type 2 diabetes (T2D) patients whose blood sugar remained poorly controlled on metformin alone. Published in NEJM Evidence, the phase 3 SYMPHONY-2 trial adds to a growing body of evidence that this traditional-medicine-derived drug could fill a meaningful gap in diabetes care.
In the 24-week trial, patients on HTD1801 saw a 0.5% greater A1c reduction than those on placebo. Over a 52-week open-label extension, patients on HTD1801 throughout achieved a mean A1c drop of 1.1% from baseline. Beyond glycemia, the drug also trimmed LDL cholesterol and improved liver stress markers — addressing the broader cardiometabolic picture of T2D.
By the numbers:
Why it matters: About one-third of T2D patients don't achieve adequate control on metformin alone, and existing add-on therapies can be expensive. HTD1801 could offer a more affordable, multi-targeted alternative — though experts caution that independent studies in more diverse populations are still needed before broader adoption.
