NCT06684106

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance

Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance: A Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Hyperlipidemia
• Ursodeoxycholic Acid
• Statin Therapy
• Glucose Intolerance

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic acid (UDCA) 500 mg	UDCA together with statin in eligible participants
DRUG	Placebo	placebo together with statin in ASCVD patients

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-11-11
• Completion: 2027-06-01
• First posted: 2024-11-12
• Last updated: 2025-09-19

Locations

2 sites across 1 country: China