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Investigation of the Gut Microbiome and Statin Response

NCT04098003 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-03-03

No results posted yet for this study

Summary

There is evidence that the bacteria that naturally reside in the gut can influence how well we respond to medications. Therefore this study will look at how rosuvastatin, a medication used to lower cholesterol levels, may change the bacteria in the gut. Investigators will also examine how the gut bacteria will affect the ability of rosuvastatin to lower cholesterol levels. There will be 4 study visits over the course of about 16 weeks.The expected duration of the study is 2 years. Investigators plan to enroll 100 healthy volunteers during that time.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Rosuvastatin

rosuvastatin 20 mg daily or placebo for eight weeks

DRUG

Placebo

Matched placebo control

Sponsors & Collaborators

  • Sony Tuteja

    lead OTHER

Principal Investigators

  • Sony Tuteja, PharmD, MS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2025-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098003 on ClinicalTrials.gov