HTD1801

DRUG10 trials

Conditions

AdolescentBile Duct DiseasesBiliary Tract DiseasesCKDCholangitisCholangitis, SclerosingDigestive System DiseasesFatty Liver, Nonalcoholic

Phase 1

A Study of HTD1801 in Healthy Subjects

CompletedNCT03099603

HighTide Therapeutics (Hong Kong) LimitedPrimary Sclerosing Cholangitis

Start: 2017-03-24End: 2017-10-03Updated: 2026-08-11

Phase 2

A POC and Dose-Ranging Study of HTD1801 in PSC Patients

CompletedNCT03333928

HighTide Therapeutics (Hong Kong) LimitedPrimary Sclerosing Cholangitis (PSC)

Start: 2018-02-09End: 2020-08-14Updated: 2026-08-25

A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

CompletedNCT03656744

HighTide Therapeutics (Hong Kong) LimitedDigestive System Diseases, Fatty Liver, Nonalcoholic, NAFLD +3

Start: 2018-11-26End: 2020-03-09Updated: 2026-08-25

A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

WithdrawnNCT03678480

HighTide Therapeutics (Hong Kong) LimitedAdolescent, Bile Duct Diseases, Biliary Tract Diseases +4

Start: 2021-03-01End: 2021-11-04Updated: 2026-08-12

HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes

CompletedNCT05623189

HighTide Therapeutics (Hong Kong) LimitedNonalcoholic Steatohepatitis (NASH), Type 2 Diabetes

Start: 2022-12-27End: 2025-03-31Updated: 2026-08-12

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

CompletedNCT06411275

Shenzhen HighTide Biopharmaceutical Ltd.Type 2 Diabetes Mellitus

Start: 2022-03-31End: 2023-01-17Updated: 2026-08-03

A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.

RecruitingNCT07496177

Institute of Medicinal Biotechnology, Chinese Academy of Medical SciencesCKD, T2DM

Start: 2026-07-09End: 2027-06-30Target: 75Updated: 2026-07-15

Phase 3

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes

CompletedNCT06350890

Shenzhen HighTide Biopharmaceutical Ltd.T2DM (Type 2 Diabetes Mellitus)

Start: 2023-11-05End: 2025-08-04Updated: 2026-08-03

Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

CompletedNCT06353347

Shenzhen HighTide Biopharmaceutical Ltd.Type 2 Diabetes Mellitus

Start: 2023-11-13End: 2025-07-30Updated: 2026-08-11

Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

CompletedNCT06415773

Shenzhen HighTide Biopharmaceutical Ltd.T2DM (Type 2 Diabetes Mellitus)

Start: 2024-06-04End: 2025-07-25Updated: 2026-08-03

Related Papers

HTD1801 in Combination with Metformin for Type 2 Diabetes.

2026-06-07

2001-LB: Symphony 1—A Randomized, Placebo-Controlled Phase 3 Study of Berberine Ursodeoxycholate as Monotherapy in Patients with Type 2 Diabetes

Diabetes2025-06-13

Berberine Ursodeoxycholate for the Treatment of Type 2 Diabetes

JAMA Network Open2025-03-0317 citations

A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes.

2021-09-1775 citations