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Bile acid pill may shield against statin blood sugar side effect

NCT ID NCT06684106

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study tests whether ursodeoxycholic acid (UDCA), a drug used for bile duct problems, can stop statins from raising blood sugar. 128 adults with high cholesterol but normal blood sugar will take either UDCA or a placebo alongside atorvastatin for 6 months. Researchers will track changes in blood sugar and safety.

What this could mean

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

Active substance
Ursodeoxycholic acid (UDCA)
What this could lead to
If it works, this could offer a way to prevent statin-related blood sugar increases, making statins safer for long-term use.
What could go wrong
This is a small, early-stage trial. The effect may be modest or not appear at all, and UDCA may cause its own side effects.

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

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-75 years old. * LDL-C≥3.4mmol/l (130 mg/dL). * Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol). * Voluntarily sign informed consent. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Cardiology, First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    RECRUITING

    Xi'an, China

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