Bile acid pill may shield against statin blood sugar side effect
NCT ID NCT06684106
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glucose intolerance are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGXi'an, Shaanxi, 710061, China
-
The First Affiliated Hospital of Xi 'an Jiaotong University
RECRUITINGXi'an, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily pill tame bad cholesterol?
- Smart pillbox aims to keep patients on track
- Can a single dose of an antipsychotic disrupt blood sugar control?
- Can AI help nurses guide At-Risk seniors to better care and lower costs?
- Can a new siRNA injection keep high triglycerides in check for the long haul?
- Could a health coach cut heart attack risk in Food-Insecure communities?