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New treatment option for Hyperlipidemia
Official title Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
ClinicalTrials.gov ID: NCT06684106
What this study is testing
What is Ursodeoxycholic acid (UDCA) 500 mg?
Ursodeoxycholic acid (UDCA) 500 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hyperlipidemia.
Also referred to as Ursodeoxycholic Acid, UDCA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Age 18-75 years old.
- LDL-C≥3.4mmol/l (130 mg/dL).
- Glycosylated hemoglobin ≤ 6.0% (42 mmol/mol).
- Voluntarily sign informed consent.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
- Scheduled for surgery within 6 months
- Pregnant, breastfeeding, or trying to become pregnant during the study or within 6 months of study completion
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
- Xi'an, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China; Xi'an, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.