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T2DM (Type 2 Diabetes Mellitus)Phase 3SYMPHONY-1NCT06350890

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

A Phase 3 study testing HTD1801 in people with T2DM (Type 2 Diabetes Mellitus), run by Shenzhen HighTide Biopharmaceutical Ltd. at 56 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 diet and exercise alone. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
HTD1801
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
408 participants
Where
56 sitesChina
Study dates
5 Nov 2023to 4 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been diagnosed with Type 2 diabetes mellitus
  • Have followed dietary and exercise interventions for at least 8 weeks prior to screening
  • If used any glucose-lowering drugs within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening
  • Have HbA1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization)
  • Have fasting plasma glucose ≤13.9 mmol/L (screening and pre-randomization)
  • Have a body mass index ≥19.0 kg/m^2 to ≤35.0 kg/m^2

Who cannot join

  • Have type 1 diabetes
  • Have had any acute diabetic complications within 12 months prior to screening
  • Have had any Grade 3 hypoglycemic event within 12 months prior to screening
  • Have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot
  • Have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening
  • Have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening
  • Have used any hypoglycemic drug during the 4-week run-in period prior to randomization
  • Have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

China56 sites

  • Baotou City Central Hospital

    Baotou, Inner Mongolia

  • Beijing Pinggu Hospital

    Beijing, Beijing Municipality

  • Fuwai Hospital, CAMS & PUMC

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • The First People's Hospital of Changde City

    Changde, Hunan

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality

  • The Third People's Hospital of Datong

    Datong, Shanxi

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • Handan First Hospital

    Handan, Hebei

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Hengshui People's Hospital (Harrison International Peace Hospital)

    Hengshui, Hebei

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia

  • Huai'an First People's Hospital

    Huai'an, Jiangsu

  • Huangshi Central Hospital

    Huangshi, Hubei

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong

  • Huzhou Central Hospital

    Huzhou, Zhejiang

  • Jinan Central Hospital

    Jinan, Shandong

  • Jingzhou Central Hospital

    Jingzhou, Hubei

  • The First People's Hospital of Kashi

    Kashgar, Xinjiang

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • Hebei Petro China Central Hospital

    Langfang, Hebei

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

  • The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)

    Luoyang, Henan

  • The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)

    Luoyang, Henan

  • Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • Nanjing First Hospital

    Nanjing, Jiangsu

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu

  • Sir Run Run Shaw Hospital Nanjing Medical University

    Nanjing, Jiangsu

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan

  • Panjin Liaohe Oilfield Gem Flower Hospital

    Panjin, Liaoning

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • The First Hospital of Qiqihar

    Qiqihar, Heilongjiang

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang

  • Shanghai East Hospital of Tongji University

    Shanghai, Shanghai Municipality

  • The Sixth People's Hospital of Shenyang

    Shenyang, Liaoning

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality

  • Tonghua Central Hospital

    Tonghua, Jilin

  • The Central Hospital of Wuhan

    Wuhan, Hubei

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi

  • Qinghai Provincial People's Hospital

    Xining, Qinghai

  • Xuancheng People's Hospital

    Xuancheng, Anhui

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Yueyang People's Hospital

    Yueyang, Hunan

  • Yuncheng Central Hospital

    Yuncheng, Shanxi

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

  • Zhumadian Central Hospital

    Zhumadian, Henan

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of HTD1801 in Patients With Type 2 Diabetes Mellitus Who Have Poor Glycemic Control After Dietary and Exercise Interventions

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.

Read the detailed description

This Phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of HTD1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. To ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. Following this period, patient eligibility will be reassessed. Eligible patients will then be randomized 2:1 to receive HTD1801 1000 mg twice daily (BID) or placebo for 24 weeks.

Patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive HTD1801 1000 mg BID for an additional 28 weeks.

Being tested
HTD1801, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTD1801Drug

    Also called berberine ursodeoxycholate

    HTD1801 1000 mg administered orally BID as four capsules

  • PlaceboDrug

    Matching placebo administered orally BID as four capsules

Study groups in NCT06350890
Study groupRoleWhat they receive
HTD1801ExperimentalAdministered orally twice daily (BID)
Receives: Drug: HTD1801
PlaceboPlacebo comparatorAdministered orally BID
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint: Mean Change in HbA1c

    Mean change in HbA1c from baseline to Week 24

    Measured: 24 Weeks

Secondary outcomes (6)

  1. Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose

    Mean change in fasting plasma glucose from baseline to Week 24

    Measured: 24 Weeks

  2. DB Phase: Mean Change in 2-Hour Postprandial Glucose

    Mean change in 2-hour postprandial glucose from baseline to Week 24

    Measured: 24 Weeks

  3. DB Phase: Proportion of patients achieving HbA1c <7.0%

    Proportion of patients achieving HbA1c target values of <7.0% at Week 24

    Measured: 24 Weeks

  4. DB Phase: Proportion of patients achieving HbA1c <6.5%

    Proportion of patients achieving HbA1c target values of <6.5% at Week 24

    Measured: 24 Weeks

  5. DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR)

    Mean change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from baseline to Week 24

    Measured: 24 Weeks

  6. DB Phase: Mean Change in Low-Density Lipoprotein Cholesterol (LDL-C)

    Mean change in LDL-C from baseline to Week 24

    Measured: 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2024
  2. Study start5 Nov 2023
  3. Primary completion12 Dec 2024
  4. Study completion4 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350890
Sponsor's protocol ID
HTD1801.PCT105
Acronym
SYMPHONY-1
Status last verified
Jul 2026
First submitted
27 Mar 2024
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HTD1801 in people with T2DM (Type 2 Diabetes Mellitus), run by Shenzhen HighTide Biopharmaceutical Ltd. at 56 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint: Mean Change in HbA1c (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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