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HighTide Biopharma Pty Ltd

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Clinical Trials

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

Phase 3

Active, not recruiting

Conditions: T2DM (Type 2 Diabetes Mellitus)

Interventions: Drug: HTD1801
Drug: Dapagliflozin

First Posted Date: 2024-05-16

Last Posted Date: 2025-01-14

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 418

Registration Number: NCT06415773

Locations: 🇨🇳
Beijing Pinggu Hospital, Beijing, China
🇨🇳
Peking University People's Hospital, Beijing, China
🇨🇳
Binzhou Medical University Hospital, Binzhou, China

and more 51 locations

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

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: HTD1801
Drug: Placebo

First Posted Date: 2024-05-13

Last Posted Date: 2024-05-13

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 113

Registration Number: NCT06411275

Locations: 🇨🇳
Liaocheng People's Hospital, Liaocheng, China
🇨🇳
Affiliated Hospital of Jiangsu University, Zhenjiang, China
🇨🇳
The First People's Hospital of Changde City, Changde, China

and more 11 locations

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

Phase 3

Active, not recruiting

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: HTD1801
Drug: Placebo

First Posted Date: 2024-04-09

Last Posted Date: 2024-07-01

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 551

Registration Number: NCT06353347

Locations: 🇨🇳
Beijing Pinggu Hospital, Beijing, China
🇨🇳
The Second Norman Bethune Hospital of Jilin University, Changchun, China
🇨🇳
Hunan Provincial People's Hospital, Changsha, China

and more 61 locations

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

Phase 3

Active, not recruiting

Conditions: T2DM (Type 2 Diabetes Mellitus)

Interventions: Drug: Placebo
Drug: HTD1801

First Posted Date: 2024-04-08

Last Posted Date: 2024-07-01

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 408

Registration Number: NCT06350890

Locations: 🇨🇳
Chongqing University Three Gorges Hospital, Chongqing, Chongqing, China
🇨🇳
Cangzhou Central Hospital, Cangzhou, Hebei, China
🇨🇳
Beijing Pinggu Hospital, Beijing, Beijing, China

and more 53 locations

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

Phase 2

Active, not recruiting

Conditions: Nonalcoholic Steatohepatitis (NASH)
Type 2 Diabetes

Interventions: Drug: HTD1801
Drug: Placebo

First Posted Date: 2022-11-21

Last Posted Date: 2025-01-27

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 218

Registration Number: NCT05623189

Locations: 🇺🇸
Catalina Research Institute, Montclair, California, United States
🇵🇷
FDI Clinical Research, San Juan, Puerto Rico
🇺🇸
The Institute for Liver Health (Arizona Liver Health), Chandler, Arizona, United States

and more 42 locations

Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis

Phase 2

Completed

Conditions: Primary Biliary Cholangitis
Primary Biliary Cirrhosis
Cholestasis
Biliary Tract Diseases
Bile Duct Stricture
Cholangitis

Interventions: Drug: HTD1801 (BUDCA)

First Posted Date: 2020-10-27

Last Posted Date: 2024-04-24

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 24

Registration Number: NCT04604652

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Northshore University Hospital, Manhasset, New York, United States
🇺🇸
Liver Institute Northwest, Seattle, Washington, United States

and more 9 locations

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

Phase 2

Withdrawn

Conditions: Primary Sclerosing Cholangitis
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adolescent

Interventions: Drug: HTD1801
Drug: Ursodeoxycholic Acid

First Posted Date: 2018-09-19

Last Posted Date: 2021-02-15

Lead Sponsor: HighTide Biopharma Pty Ltd

Registration Number: NCT03678480

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

Phase 2

Completed

Conditions: NAFLD
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Digestive System Diseases
Fatty Liver, Nonalcoholic
Type 2 Diabetes Mellitus (T2DM)

Interventions: Drug: Placebo
Drug: HTD1801

First Posted Date: 2018-09-04

Last Posted Date: 2021-12-29

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 101

Registration Number: NCT03656744

Locations: 🇺🇸
Excel Medical Clinical Trials, Boca Raton, Florida, United States
🇺🇸
Harborview Medical Center, Seattle, Washington, United States
🇺🇸
Gastro One, Germantown, Tennessee, United States

and more 12 locations

A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia

Phase 1

Completed

Conditions: Hypercholesterolemia

Interventions: Drug: HTD1801 Tablets, 500 mg
Drug: HTD1801 Tablets, 1000 mg
Drug: HTD1801 Tablets, 2000 mg
Drug: Placebo to match 500 mg HTD1801
Drug: Placebo to match 1000 mg HTD1801
Drug: Placebo to match 2000 mg HTD1801

First Posted Date: 2017-12-21

Last Posted Date: 2023-03-03

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 50

Registration Number: NCT03381287

Locations: 🇦🇺
Q-Pharm Pty Ltd., Herston, Queensland, Australia
🇦🇺
CMAX Clinical Research Pty Ltd, Adelaide, South Australia, Australia
🇦🇺
Linear Clinical Research, Nedlands, Western Australia, Australia

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

Phase 2

Completed

Conditions: Primary Sclerosing Cholangitis (PSC)

Interventions: Drug: Placebo
Drug: HTD1801

First Posted Date: 2017-11-07

Last Posted Date: 2022-04-06

Lead Sponsor: HighTide Biopharma Pty Ltd

Target Recruit Count: 59

Registration Number: NCT03333928

Locations: 🇨🇦
Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, Ontario, Canada
🇺🇸
Mercy Medical Center, Baltimore, Maryland, United States
🇺🇸
University of Miami, Miami, Florida, United States

and more 21 locations

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