New diabetes drug HTD1801 put to the test in 551-Person trial

NCT ID NCT06353347

Completed Disease control Sponsor: Shenzhen HighTide Biopharmaceutical Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This Phase 3 trial tested whether HTD1801 (berberine ursodeoxycholate) can help people with type 2 diabetes who aren't well controlled on metformin alone. Over 500 participants received either the drug or a placebo for 24 weeks. The main goal was to see if the drug lowered blood sugar levels (HbA1c) more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: berberine ursodeoxycholate (HTD1801)
What this could lead to: If it works, this could offer a new oral option to help people with type 2 diabetes better control their blood sugar when metformin alone isn't enough.
What could go wrong: This is a completed Phase 3 trial, but results are not yet public. The drug may not prove significantly better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TYPE 2 DIABETES MELLITUS

Contacts and locations

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, China
Anhui Provincial Hospital

Hefei, China
Baogang Hospital of Inner Mongolia

Baotou, China
Beijing Friendship Hospital, Capital Medical University

Beijing, China
Beijing Luhe Hospital Capital Medical University

Beijing, China
Beijing Pinggu Hospital

Beijing, China
Chongqing University Three Gorges Hospital

Chongqing, China
Handan First Hospital

Handan, China
Hebei Petro China Center Hospital

Langfang, China
Hengshui People's Hospital (Harrison International Peace Hospital)

Hengshui, China
Heze Municipal Hospital

Heze, China
Huai'an First People's Hospital

Huai'an, China
Huangshi Central Hospital

Huangshi, China
Huizhou Municipal Central Hospital

Huizhou, China
Hunan Provincial People's Hospital

Changsha, China
Huzhou Central Hospital

Huzhou, China
Jinan Central Hospital

Jinan, China
Jingzhou Central Hospital

Jingzhou, China
Jinzhou Central Hospital

Jinzhou, China
Liaocheng People's Hospital

Liaocheng, China
Nanfang Hospital, Southern Medical University

Guangzhou, China
Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School

Nanjing, China
Nanjing First Hospital

Nanjing, China
Nanjing Jiangning Hospital

Nanjing, China
Panjin Liaohe Oilfield Gem Flower Hospital

Panjin, China
Peking Union Medical College Hospital

Beijing, China
Peking University People's Hospital

Beijing, China
People's Hospital of Tianjin

Tianjin, China
Shanghai East Hospital of Tongji University

Shanghai, China
Shanghai Pudong New Area People's Hospital

Shanghai, China
Shengjing Hospital of China Medical University

Shenyang, China
Shenzhen People's Hospital

Shenzhen, China
Siping City Central People's Hospital

Siping, China
Sir Run Run Hospital Nanjing Medical University

Nanjing, China
Taihe Hospital

Shiyan, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China
The Central Hospital of Wuhan

Wuhan, China
The First Affiliated Hospital of Henan University of Science and Technology (Jinghua)

Luoyang, China
The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan)

Luoyang, China
The First Affiliated Hospital of Nanyang Medical College

Nanyang, China
The First Affiliated Hospital of Suzhou University

Suzhou, China
The First Hospital of Qiqihar

Qiqihar, China
The First People's Hospital of Changde City

Changde, China
The First People's Hospital of Kashgar

Kashgar, China
The First People's Hospital of Nanning

Nanning, China
The First People's Hospital of Xiangtan City

Xiangtan, China
The First People's Hospital of Zunyi

Zunyi, China
The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China
The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China
The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China
The Second Hospital of Anhui Medical University

Hefei, China
The Second Norman Bethune Hospital of Jilin University

Changchun, China
The Sixth People's Hospital of Shenyang

Shenyang, China
The Third People's Hospital of Datong

Datong, China
The Third Xiangya Hospital of Central South University

Changsha, China
The University of Hong Kong - Shenzhen Hospital

Shenzhen, China
Tonghua Central Hospital

Tonghua, China
Yanan University Affiliated Hospital

Yanan, China
Yijishan Hospital of Wannan Medical College

Wuhu, China
Yueyang People's Hospital

Yueyang, China
Yuncheng Central Hospital

Yuncheng, China
Zhumadian Central Hospital

Zhumadian, China
Zhuzhou Central Hospital

Zhuzhou, China
Zibo Central Hospital

Zibo, China

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