A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Diet and Exercise

Phase 2 Completed 113 enrolled HighTide Biopharma Pty Ltd Shenzhen HighTide Biopharmaceutical Ltd. · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone.

Timeline

Start: 2022-03-31
Primary completion: 2023-01-17
Completion: 2023-01-17

Outcome

Met primary endpoint

paper The primary end point was achieved with significant dose-dependent reductions PMID 40029660 ↗

Publications

Ji L, Ma J, Ma Y, Cheng Z, Gan S, Yuan G, Liu D, Li S, Liu Y, Xue X, Bai J, Wang K, Cai H, Li S, Liu K, Yu M, Liu L. Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e2462185. doi: 10.1001/jamanetworkopen.2024.62185.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	berberine ursodeoxycholate	Small molecule	500 mg	Oral
Subject	berberine ursodeoxycholate	Small molecule	1000 mg	Oral