HyperlipidemiaURSTARNCT06684106
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
A study testing Ursodeoxycholic acid (UDCA) 500 mg in people with Hyperlipidemia and Ursodeoxycholic Acid, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial summary
The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Ursodeoxycholic Acid, Statin Therapy
- What is being tested?
- Ursodeoxycholic acid (UDCA) 500 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- 25 Nov 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years old.
- LDL-C≥3.4mmol/l (130 mg/dL).
- Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
- Voluntarily sign informed consent.
Who cannot join
- Previous diagnosis of diabetes or prediabetes.
- Past or current use of hypoglycemic drugs.
- Oral administration of statin lipid-lowering drugs within three months before enrollment.
- Combined oral drug quantity ≥3.
- History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease).
- Active liver disease (defined as elevation of alanine aminotransferase (ALT), aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) from any existing known liver infectious, neoplastic, or metabolic pathologic cause or unknown cause at the time of screening), Severe hepatic insufficiency and biliary obstruction.
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- Difficult to control hypertension: defined as systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg despite antihypertensive therapy prior to randomization.
- Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method
- New York Heart Association (NYHA) Class IV heart failure or a known left ventricular ejection fraction < 25%
- A clinically significant and drug- or ablation-resistant arrhythmia within 3 months prior to randomization
- An acute or severe systemic infection, or any of the following diseases: hematological disorders, autoimmune disorders, malignant tumors, psychiatric patients, or other serious or unstable conditions that could impact study health status
- Scheduled for surgery within 6 months
- Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion
- Subjects with alcohol or other drug addiction
- Secondary hypercholesterolemia, such as hypothyroidism or nephrotic syndrome
- A history of allergic reaction to any study drug or its excipients or similar chemical classes of drugs
- A family history of homozygous familial hypercholesterolemia
- Participants currently enrolled in another clinical trial, or who cannot adhere to 6-month follow-up
- Any condition that the investigator considers unsuitable for participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yue Wu, 0086-029-8532-3664, imyuewu@qq.com
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an
Yue Wu, 0086-85323810, imyuewu@qq.com
About this study
Official title: Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are:
- Will UDCA reduce the incidence of glucose intolerance in participants taking oral statins?
- Will the use of UDCA decrease other adverse events in patients taking oral statins?
Participants will:
- Take Atorvastatin combined with UDCA or a placebo daily for 6 months
- Have follow-up visits on day 40, day 110, and day 180 Have their examination indicators recorded.
- Being tested
- Ursodeoxycholic acid (UDCA) 500 mg, Placebo
- Medical subject headings
- Hyperlipidemias, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acid (UDCA) 500 mgDrug
Also called Ursodeoxycholic Acid, UDCA
UDCA together with statin in eligible participants
PlaceboDrug
placebo together with statin in ASCVD patients
| Study group | Role | What they receive |
|---|---|---|
| Ursodeoxycholic acid group | Experimental | Ursodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day. Receives: Drug: Ursodeoxycholic acid (UDCA) 500 mg |
| placebo group | Placebo comparator | This group of participants receive placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
Measured: 6 months after randomization
Secondary outcomes (5)
Concentration of fasting blood glucose
The concentration of fasting blood glucose was measured and serum was extracted for laboratory testing.
Measured: 6 months after randomization
Concentration of fasting islets
The concentration of fasting islets was measured and serum was extracted for laboratory testing. we use the level of physiological parameter to describe the concentration of fasting islets.
Measured: 6 months after randomization
Concentration of blood lipid
The concentration of blood lipid was measured and serum was extracted for laboratory testing.we use the level of physiological parameter to describe the concentration of blood lipid, including "the level of triglycerides","the level of low-density lipoprotein", "the level of high-density lipoprotein", "the level of total cholesterol" ,"the level of Lipoprotein(a)".
Measured: 6 months after randomization
Body composition analysis Fat mass
The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g."Fat mass"
Measured: 6 months after randomization
Body composition analysis Muscle mass
The Body composition analysis was measured by the Inbody. we wue the physiological parameter to describe the body composition. e.g. "Muscle mass".
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start25 Nov 2024
- Primary completion11 Nov 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zuyi Yuan, Professor, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684106
- Sponsor's protocol ID
- XJTU1AF2023LSK-149-01
- Other IDs
- CSCF2022B04
- Acronym
- URSTAR
- Status last verified
- Sep 2025
- First submitted
- 4 Nov 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and ethical restrictions.
Publications
Yu Y, Zheng J, She J, Yuan Z, Wu Y. Effects of ursodeoxycholic acid on statin-induced impaired glucose tolerance: study protocol for a randomized controlled trial. BMJ Open. 2026 Jul 28;16(7):e117417. doi: 10.1136/bmjopen-2026-117417.
PubMed 42521308
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06684106
- Acronym / sponsor ID
- URSTAR / XJTU1AF2023LSK-149-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA. The primary questions it aims to answer are:
- Will UDCA reduce the incidence of glucose intolerance in participants taking oral statins?
- Will the use of UDCA decrease other adverse events in patients taking oral statins?
Participants will:
- Take Atorvastatin combined with UDCA or a placebo daily for 6 months
- Have follow-up visits on day 40, day 110, and day 180 Have their examination indicators recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ursodeoxycholic acid group | Experimental | Drug: Ursodeoxycholic acid (UDCA) 500 mgUrsodeoxycholic acid (UDCA) 500 mg: This group of participants receive UDCA 500mg per day. |
| placebo group | Placebo comparator | Drug: PlaceboThis group of participants receive placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old.
- LDL-C≥3.4mmol/l (130 mg/dL).
- Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
- Voluntarily sign informed consent.
Key exclusion criteria (19 listed)
- Previous diagnosis of diabetes or prediabetes.
- Past or current use of hypoglycemic drugs.
- Oral administration of statin lipid-lowering drugs within three months before enrollment.
- Combined oral drug quantity ≥3.
- History of ASCVD (previous myocardial infarction, ACS, stroke or TIA within 1 year, symptomatic peripheral vascular disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic acid (UDCA) 500 mgAlso: Ursodeoxycholic Acid, UDCAUDCA together with statin in eligible participants | Drug | Ursodeoxycholic acid group |
| Placeboplacebo together with statin in ASCVD patients | Drug | placebo group |
Primary outcome
HbA1c
Time frame: 6 months after randomization
Changes of glycosylated hemoglobin after taking ursodeoxycholic acid for half a year
5 secondary outcomes
Concentration of fasting blood glucose
Time frame: 6 months after randomization
Concentration of fasting islets
Time frame: 6 months after randomization
Concentration of blood lipid
Time frame: 6 months after randomization
Body composition analysis Fat mass
Time frame: 6 months after randomization
Body composition analysis Muscle mass
Time frame: 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 42521308Yu Y, Zheng J, She J, Yuan Z, Wu Y. Effects of ursodeoxycholic acid on statin-induced impaired glucose tolerance: study protocol for a randomized controlled trial. BMJ Open. 2026 Jul 28;16(7):e117417. doi: 10.1136/bmjopen-2026-117417.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuyi Yuan, Professor study chair
First Affiliated Hospital Xi'an Jiaotong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ursodeoxycholic acid (UDCA) 500 mg in people with Hyperlipidemia and Ursodeoxycholic Acid, run by First Affiliated Hospital Xi'an Jiaotong University at 2 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 4 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Yu (0086-85323810, yueyu05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months after randomization). 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 NCT06684106, which also lists 1 linked publication.
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 30 Jun 2026.