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Statins

Rosuvastatin for Liver Cirrhosis (LCN RESCU Trial)

Phase 2

Recruiting

Led By Jody Ciolino

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 96 weeks

Summary

This trial tests if a drug can safely and effectively treat cirrhosis.

Who is the study for?

Adults aged 18-75 with compensated cirrhosis due to nonalcoholic steatohepatitis, alcohol-associated liver disease, chronic viral hepatitis, or cryptogenic causes. Participants must have a clinical diagnosis of cirrhosis confirmed by biopsy or other criteria and cannot be on statins or have conditions like uncontrolled diabetes, recent serious cardiovascular events, active substance abuse, certain infections or cancers.

What is being tested?

The trial is testing the safety and effectiveness of rosuvastatin versus a placebo in patients with compensated cirrhosis over two years. It's a phase 2 study where neither the participants nor the researchers know who receives the actual medication (double-blind).

What are the potential side effects?

Potential side effects of rosuvastatin may include muscle pain or weakness (myositis), increased risk for liver injury, digestive issues such as constipation or nausea, headache, feeling dizzy or weak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change in liver stiffness

Secondary study objectives

All-cause mortality

Change in Child-Turcotte-Pugh score

Change in Enhanced Liver Fibrosis test

+15 more

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630

genital fungal infection

100%

80%

60%

40%

20%

Study treatment Arm

Adverse Events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry) rosuvastatin by mouth once daily, followed by a period of 96 weeks rosuvastatin 20 mg daily (10 mg daily for participants of East-Asian ancestry).

Group II: PlaceboPlacebo Group1 Intervention

Open-label lead-in period of 4 weeks on 20 mg (10 mg for participants of East ancestry) rosuvastatin by mouth once daily, followed by a period of 96 weeks placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rosuvastatin

2019

Completed Phase 4

~3150

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