Scientific Publications

Symphony 1: A Randomized, Placebo-Controlled Phase 3 Study of Berberine Ursodeoxycholate (HTD1801) as Monotherapy in Patients with Type 2 Diabetes

Linong Ji, Jianhua Ma, Zhifeng Cheng, Dexue Liu, Hanqing Cai, Sihong Wang, Xiaomei Wang, Yujin Ma, Xiaojing Wang, Jie Han, Guoyue Yuan, Yawei Zhang, Fang Yu, Kui Liu, Meng Yu, Liping Liu. Presented at the ADA 85th Scientific Sessions Conference, June 21-23, 2025.

Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes A Randomized Clinical Trial

Linong Ji, Jianhua Ma, Yujin Ma, Zhifeng Cheng, Shenglian Gan, Guoyue Yuan, Dexue Liu, Sheli Li, Yu Liu, Xia Xue, Jie Bai, Kun Wang, Hanqing Cai, Shu Li, Kui Liu, Meng Yu, Liping Liu. JAMA Netw Open. 2025;8(3):e2462185. doi:10.1001/jamanetworkopen.2024.62185

Efficacy of Berberine Ursodeoxycholate (HTD1801) in Chinese and Western Patients with T2DM +/- MASH

Shenglian Gan, Linong Ji, Jianhua Ma, Zhifeng Cheng, Nadege T. Gunn, Guy W. Neff, Kui Liu, Leigh MacConell. Presented at the 60th EASD Annual Meeting, September 9-13, 2024.

Berberine Ursodeoxycholate (HTD1801) Provides a Unique Therapeutic Approach for Patients with Metabolic Diseases and Severe Insulin Resistance

Leigh MacConell, Alexander Liberman, Abigail Flyer, Kui Liu. Presented at the 60th EASD Annual Meeting, September 9-13, 2024.

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Berberine Ursodeoxycholate (HTD1801) Improves Key Glycemic and Cardiometabolic Parameters Across the T2DM Disease Spectrum

Linong Ji, Jianhua Ma, Yujin Ma, Zhifeng Cheng, Shenglian Gan, Guoyue Yuan, Dexue Liu, Sheli Li, Yu Liu, Xia Xue, Jie Bai, Kun Wang, Hanqing Cai, Shu Li, Kui Liu, Meng Yu, Liping Liu. Presented at the ADA 84th Scientific Sessions, June 21-24, 2024.

Efficacy of Berberine Ursodeoxycholate (HTD1801) Compared to Ongoing Use of GLP-1 Receptor Agonists in Patients with MASH and T2DM

Stephen Harrison, Guy Neff, Nadege Gunn, Abigail Flyer, Leigh MacConell. Presented at the EASL International Liver Congress, June 05-08, 2024.

Assessment of MRI Response in Patients with NASH and T2DM Treated with HTD1801 (Berberine Ursodeoxycholate) for 18 Weeks

Nadege Gunn, Stephen A. Harrison, Guy Neff, Abigail Flyer, Alexander Liberman, Leigh MacConell. Presented at The Liver Meeting AASLD, November 10-14, 2023.

HTD1801 Improves Glycemic Control in Patients with Type 2 Diabetes: Double-Blind, Placebo-Controlled, Phase 2 Study

Linong Ji, Jianhua Ma, Yujin Ma, Zhifeng Cheng, Shenglian Gan, Guoyue Yuan, Dexue Liu, Sheli Li, Yu Liu, Xia Xue, Jie Bai, Kun Wang, Hanqing Cai, Shu Li, Liping Liu. Presented at the 59th EASD Annual Meeting, October 2-6, 2023.

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Improvements in Liver Fibroinflammation (as Assessed by Corrected T1 [cT1]) with HTD1801 (Berberine Ursodeoxycholate) Treatment in Patients with Nonalcoholic Steatohepatitis and Type 2 Diabetes Mellitus

Stephen A. Harrison, Nadege Gunn, Guy Neff, Abigail Flyer, Alexander Liberman, Leigh MacConell. Presented at the EASL International Liver Congress, June 21-24, 2023.

A Randomized, Dose-Finding, Proof of Concept Study of Berberine Ursodeoxycholate in Patients with Primary Sclerosing Cholangitis

Kris V. Kowdley, Lisa Forman, Bertus Eksteen, Nadege Gunn, Vinay Sundaram, Charles Landis, Stephen A. Harrison, Cynthia Levy, Alexander Liberman, Adrian M. Di Bisceglie, Gideon M. Hirschfield. Am J Gastro. 2022;117(11):1805-15.

HTD1801 (Berberine Ursodeoxycholate), A Unique Single Molecule with Multiple Beneficial Effects in Metabolic and Liver Diseases

Meng Yu, Ru Bai, Xinxiang Fu, Zhaobin Chen, Weijian Liu, Leigh MacConell. Presented at the EASL International Liver Congress, June 22-26, 2022.

Effects of HTD1801 (Berberine Ursodeoxycholate) on Non-Invasive Fibrosis Markers in Subjects with Presumed NASH and Type 2 Diabetes

Stephen A. Harrison, Nadege Gunn, Guy Neff, Anita Kohli, Leigh MacConell, Rohit Loomba. Presented at The Liver Meeting AASLD, November 12-15, 2021.

A Phase 2, Proof of Concept, Randomized Controlled Trial of Berberine Ursodeoxycholate (BUDCA) in Patients with Presumed Non-Alcoholic Steatohepatitis (NASH) and Type 2 Diabetes

Stephen A. Harrison, Nadege Gunn, Guy W. Neff, Anita Kohli, Liping Liu, Abbey Flyer, Lawrence Goldkind, Adrian M. Di Bisceglie. Nat Commun. 2021;12(1):5503.

Cardiometabolic Effects of HTD1801 (Berberine Ursodeoxycholate) in Subjects with Presumed NASH and Type 2 Diabetes

Guy Neff, Anita Kohli, Nadege Gunn, Abigail Flyer, Leigh MacConell, Stephen Harrison. Presented at the 7th Paris NASH Meeting, September 9-10, 2021.

Pharmacokinetics and Pharmacodynamics of HTD1801 (Berberine Ursodeoxycholate, BUDCA) in Patients with Hyperlipidemia

Adrian Di Bisceglie, Gerald Watts, Philip Lavin, Meng Yu, Ru Bai, Liping Liu. Lipids Health Dis. 2020;19(1):239.

A New Analogue of Islet Neogenesis Associated Protein with Higher Structural and Plasma Stability

Soledad Lynn, Yanis Ricardo Espinosa Silva, Luis Diambra, Andres Norman McCarthy, Liping Liu, Ru Bai, Carolina Lisi Roman, Barbara Maiztegui, Luis Emilio Flores, Juan Jose Gagliardino. J Biomol Struct Dyn. 2021;39(3):766-776.

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