Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes
SYMPHONY-1
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
1 other identifier
interventional
408
1 country
56
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2023
CompletedFirst Submitted
Initial submission to the registry
March 27, 2024
CompletedFirst Posted
Study publicly available on registry
April 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2025
CompletedDecember 29, 2025
December 1, 2025
1.1 years
March 27, 2024
December 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Endpoint: Mean Change in HbA1c
Mean change in HbA1c from baseline to Week 24
24 Weeks
Secondary Outcomes (6)
Double Blind (DB) Phase: Mean Change in Fasting Plasma Glucose
24 Weeks
DB Phase: Mean Change in 2-Hour Postprandial Glucose
24 Weeks
DB Phase: Proportion of patients achieving HbA1c <7.0%
24 Weeks
DB Phase: Proportion of patients achieving HbA1c <6.5%
24 Weeks
DB Phase: Mean Change in Insulin Sensitivity (HOMA-IR)
24 Weeks
- +1 more secondary outcomes
Other Outcomes (6)
Open Label Extension (OLE) Phase: Mean Change in HbA1c
52 weeks
OLE Phase: Mean change in 2-Hour Postprandial Glucose
52 Weeks
OLE Phase: Proportion of patients achieving HbA1c <7.0%
52 Weeks
- +3 more other outcomes
Study Arms (2)
HTD1801
EXPERIMENTALAdministered orally twice daily (BID)
Placebo
PLACEBO COMPARATORAdministered orally BID
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Xuancheng People's Hospital
Xuancheng, Anhui, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Handan First Hospital
Handan, Hebei, China
Hengshui People's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, China
Hebei Petro China Central Hospital
Langfang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology (Jinghua)
Luoyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology (Kaiyuan)
Luoyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Zhumadian Central Hospital
Zhumadian, Henan, China
Huangshi Central Hospital
Huangshi, Hubei, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
The First People's Hospital of Changde City
Changde, Hunan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Yueyang People's Hospital
Yueyang, Hunan, China
Baotou City Central Hospital
Baotou, Inner Mongolia, China
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Sir Run Run Shaw Hospital Nanjing Medical University
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
Panjin Liaohe Oilfield Gem Flower Hospital
Panjin, Liaoning, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Shanghai East Hospital of Tongji University
Shanghai, Shanghai Municipality, China
The Third People's Hospital of Datong
Datong, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
People's Hospital of Tianjin
Tianjin, Tianjin Municipality, China
The First People's Hospital of Kashi
Kashgar, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kui Liu, MD
Shenzhen HighTide Biopharmaceutical Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2024
First Posted
April 8, 2024
Study Start
November 5, 2023
Primary Completion
December 12, 2024
Study Completion
August 4, 2025
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share