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HMG-CoA Reductase Inhibitor

Rosuvastatin and Gut Microbiome in Healthy Subjects (INGEST Trial)

Phase 4
Waitlist Available
Led By Sony Tuteja, PharmD, MS
Research Sponsored by Sony Tuteja
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is aged 18 to 65 years. The gut microbiome has been shown to change gradually with time, although there is no cut-off in age when this occurs.
Be older than 18 years old
Must not have
Liver dysfunction (alanine aminotransferase > 2 times the upper limit of normal).
Diabetes mellitus (DM) - Diabetes itself may affect the gut microbiome although this has not been extensively studied. In addition to a prior diagnosis of diabetes mellitus other than that related to pregnancy, a fasting glucose level of greater than 125mg/dL will be used to exclude participation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will study how rosuvastatin affects gut bacteria and cholesterol levels. 100 healthy volunteers will be enrolled over 2 years, with 4 study visits during that time.

Who is the study for?
Healthy volunteers aged 18 to 65, without diabetes, hypothyroidism, cancer history, gut inflammation disorders like IBD or celiac disease. Must not have used antibiotics in the last 6 months or be current smokers. Participants should not have cardiovascular diseases, kidney/liver dysfunction, extreme BMI values (<18.5 or >30), bowel resection surgery (except appendectomy), abnormal bowel frequency, and must agree to use birth control.
What is being tested?
The study is testing how rosuvastatin affects gut bacteria and cholesterol levels in healthy individuals over approximately 16 weeks with four visits. It will also explore how gut bacteria influence the drug's effectiveness at lowering cholesterol.
What are the potential side effects?
Rosuvastatin may cause muscle pain, constipation or diarrhea, nausea, headache; however specific side effects related to changes in gut microbiome due to the drug are currently unknown and part of what this trial aims to discover.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver enzyme levels are higher than normal.
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I have diabetes with a fasting glucose level over 125mg/dL.
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I have a history of inflammatory bowel diseases like IBD or celiac disease.
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I have not had any bowel surgery except for an appendectomy.
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I have been diagnosed with an underactive thyroid.
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I have had diarrhea in the last two weeks.
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I have taken antibiotics in the last 6 months.
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I have had cancer before.
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My kidney function is impaired (creatinine >1.5 mg/dl).
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I have heart issues, high blood pressure, or high cholesterol affecting my gut health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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
Change in bacterial abundance
Secondary study objectives
Change in LDL-C
Other study objectives
Change in fecal bile acid concentrations
Change in serum FGF19 levels

Side effects data

From 2018 Phase 4 trial • 12 Patients • NCT03074630
8%
genital fungal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Adverse Events

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RosuvastatinExperimental Treatment1 Intervention
rosuvastatin 20 mg daily for eight weeks
Group II: PlaceboPlacebo Group1 Intervention
placebo daily for eight weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150

Find a Location

Who is running the clinical trial?

Sony TutejaLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Sony Tuteja, PharmD, MSPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
3 Previous Clinical Trials
985 Total Patients Enrolled

Media Library

Rosuvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098003 — Phase 4
~3 spots leftby Mar 2025
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