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

NCT06353347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2025-11-26

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

HTD1801

HTD1801 1000 mg administered orally BID as four capsules

DRUG

Placebo

Matching placebo administered orally BID as four capsules

Sponsors & Collaborators

  • Shenzhen HighTide Biopharmaceutical Ltd.

    collaborator UNKNOWN

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Kui Liu, MD · Shenzhen HighTide Biopharmaceutical Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2024-12-12
Completion
2025-07-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353347 on ClinicalTrials.gov