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A new investigational drug, berberine ursodeoxycholate (HTD1801), has been found to lower blood sugar, improve cholesterol levels, and enhance liver function in people with type 2 diabetes (T2D).
The findings, published in JAMA Network Open, come from a phase 2 clinical trial conducted by researchers across 14 medical centers in China, including Peking University People’s Hospital.
Type 2 diabetes is a growing global health concern, driven by obesity, sedentary lifestyles, and insulin resistance.
Many patients struggle to keep their blood sugar levels within a healthy range, increasing their risk of heart disease, liver disease, and other metabolic complications.
In China, less than half of T2D patients achieve target blood sugar levels, highlighting the need for new treatment options. HTD1801 is a promising new drug because it:
Lowers blood sugar through its effect on AMP kinase activation (a key metabolic regulator).
Reduces inflammation by inhibiting the NLRP3 inflammasome, which is linked to metabolic diseases.
Improves liver function due to its bile acid component, ursodeoxycholic acid.
The trial included 113 patients with T2D who had HbA1c levels between 7.0% and 10.5% (a measure of long-term blood sugar control).
Participants first completed a four-week placebo run-in period, where they received guidance on diet, blood sugar monitoring, and medication use to establish a stable baseline.
Afterward, they were randomly assigned to receive either:
A placebo,
Low-dose HTD1801 (500 mg twice daily), or
High-dose HTD1801 (1,000 mg twice daily).
Researchers tracked changes in blood sugar, cholesterol, liver function, and inflammation markers over 12 weeks.
Major Results
Improved Blood Sugar Control
HbA1c dropped by 0.4% (low-dose) and 0.7% (high-dose) compared to placebo.
Fasting blood sugar decreased, with the high-dose group seeing an 18.4 mg/dL drop.
More patients reached target blood sugar levels under 7.0% in the HTD1801 groups.
Better Cholesterol and Heart Health Markers
LDL (“bad”) cholesterol and non-HDL cholesterol decreased significantly.
Triglyceride levels dropped, supporting better lipid metabolism.
High-sensitivity C-reactive protein (hs-CRP), a marker of inflammation, also decreased.
Enhanced Liver Function
Liver enzyme levels (ALT and AST) improved, suggesting better liver health.
This is especially important for T2D patients, as they often develop fatty liver disease.
Safety and Side Effects
HTD1801 was generally well tolerated, with 97.3% of participants completing the study. No one stopped treatment due to side effects.
Common mild side effects included:
Slightly higher rates of hyperlipidemia, sinus bradycardia, and proteinuria in the high-dose group.
Mild nausea and diarrhea (infrequent but seen at the higher 1,000 mg dose).
One case of retinal hemorrhage (but not linked to the drug).
Importantly:
No severe hypoglycemia was reported.
No significant weight gain was observed, which is a common issue with some diabetes medications.
What’s Next?
Given these promising results, ongoing phase 3 trials are now testing HTD1801 in larger populations over a longer period. If successful, HTD1801 could become a new oral treatment option for type 2 diabetes, especially for patients struggling with blood sugar, cholesterol, and liver health.
This study highlights HTD1801’s potential advantages over existing diabetes drugs:
Multi-target benefits (glucose, lipids, liver function).
No severe hypoglycemia.
No significant weight gain.
With further research, HTD1801 could offer a new approach to managing type 2 diabetes, helping millions achieve better health with fewer risks.
The research findings can be found in JAMA Network Open.
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