NCT06350890 (SYMPHONY-1) is a Phase 3 clinical trial of HTD1801 in T2DM (Type 2 Diabetes Mellitus), sponsored by HighTide Biopharma Pty Ltd.

Who is sponsoring NCT06350890?

NCT06350890 is sponsored by HighTide Biopharma Pty Ltd.

What drugs are being tested in NCT06350890?

Interventions in NCT06350890: HTD1801, Placebo.

What condition does NCT06350890 study?

NCT06350890 studies T2DM (Type 2 Diabetes Mellitus).

Is NCT06350890 still recruiting?

NCT06350890 is currently completed. Last updated 29 December 2025.

Last reviewed 2025-12-29 · How we verify

NCT06350890: SYMPHONY-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 29 December 2025

What this trial tests

Phase 3 trial testing HTD1801 in T2DM (Type 2 Diabetes Mellitus) in 408 participants. Completed in 4 August 2025.

Timeline

5 November 2023

Primary endpoint
12 December 2024

4 August 2025

Quick facts

Lead sponsor	HighTide Biopharma Pty Ltd
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	408
Start date	5 November 2023
Primary completion	12 December 2024
Estimated completion	4 August 2025
Sites	56 locations across China

Drugs / interventions tested

HTD1801 — full drug profile →
Placebo

Conditions studied

T2DM (Type 2 Diabetes Mellitus) — all drugs for T2DM (Type 2 Diabetes Mellitus) →

Sponsor

HighTide Biopharma Pty Ltd — full company profile →

Who can join

Adults 18 to 75, any sex, with T2DM (Type 2 Diabetes Mellitus). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 diet and exercise alone.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Bile Acids and Type 2 Diabetes: Roles in Glucose Homeostasis and Therapeutic Opportunities.
Lin Y, Hu C, Wang S, Lin H. · · 2025 · cited 2× · PMID 40559425 · DOI 10.3390/metabo15060401

Verify or expand the search:

Other trials of HTD1801

Trials testing the same drug.

NCT07496177 — A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chro · Phase 2 · not yet recruiting
NCT06415773 — Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Contr · Phase 3 · completed
NCT06353347 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled Wit · Phase 3 · completed
NCT05623189 — HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes · Phase 2 · completed
NCT06411275 — A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Di · Phase 2 · completed

Other recruiting trials for T2DM (Type 2 Diabetes Mellitus)

Currently open trials in the same condition.

NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · recruiting
NCT07005362 — Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D · recruiting
NCT07244003 — Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control · Phase 4 · recruiting
NCT07172997 — Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers · active not recruiting
NCT06094491 — Virtual Diabetes Group Visits Across Health Systems · Phase 2 · active not recruiting

Other HighTide Biopharma Pty Ltd trials

Trials by the same sponsor.

NCT06415773 — Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Contr · Phase 3 · completed
NCT06353347 — Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled Wit · Phase 3 · completed
NCT05623189 — HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes · Phase 2 · completed
NCT06411275 — A Phase 2 Study of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Di · Phase 2 · completed
NCT04604652 — Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06350890 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HighTide Biopharma Pty Ltd
Last refreshed: 29 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06350890.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing