Trial Outcomes & Findings for Investigation of the Gut Microbiome and Statin Response (NCT NCT04098003)
NCT ID: NCT04098003
Last Updated: 2026-07-09
Results Overview
Change in relative abundance (8 weeks - baseline) = The percentage of total sequenced microbial reads assigned to a bacterial taxon (based on log 10 transformed values) at baseline were subtracted from the percentage of total sequenced microbial reads assigned to a taxon at 8 weeks. Negative values signify that the % of reads belonging to a particular species is decreasing.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
8 weeks
Results posted on
2026-07-09
Participant Flow
Screening visit occurred prior to randomization to cohorts. 45 participants signed consent to participate and went on to be randomized/complete all study visits.
Participant milestones
| Measure |
Rosuvastatin
rosuvastatin 20 mg daily for eight weeks
Rosuvastatin: rosuvastatin 20 mg daily or placebo for eight weeks
|
Placebo
placebo daily for eight weeks
Placebo: Matched placebo control
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
13
|
|
Overall Study
COMPLETED
|
32
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of the Gut Microbiome and Statin Response
Baseline characteristics by cohort
| Measure |
Rosuvastatin
n=32 Participants
rosuvastatin 20 mg daily for eight weeks
Rosuvastatin: rosuvastatin 20 mg daily or placebo for eight weeks
|
Placebo
n=13 Participants
placebo daily for eight weeks
Placebo: Matched placebo control
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=20 Participants
|
21 years
n=20 Participants
|
25 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
31 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
41 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 8 weeksChange in relative abundance (8 weeks - baseline) = The percentage of total sequenced microbial reads assigned to a bacterial taxon (based on log 10 transformed values) at baseline were subtracted from the percentage of total sequenced microbial reads assigned to a taxon at 8 weeks. Negative values signify that the % of reads belonging to a particular species is decreasing.
Outcome measures
| Measure |
Rosuvastatin
n=32 Participants
rosuvastatin 20 mg daily for eight weeks
Rosuvastatin: rosuvastatin 20 mg daily or placebo for eight weeks
|
Placebo
n=13 Participants
placebo daily for eight weeks
Placebo: Matched placebo control
|
|---|---|---|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides dorei
|
0.014 relative abundance difference (%)
Standard Error 0.070
|
-0.203 relative abundance difference (%)
Standard Error 0.116
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides fragilis
|
-0.046 relative abundance difference (%)
Standard Error 0.049
|
-0.063 relative abundance difference (%)
Standard Error 0.089
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides ovatus
|
-0.043 relative abundance difference (%)
Standard Error 0.060
|
-0.160 relative abundance difference (%)
Standard Error 0.113
|
|
Change in Bacterial Abundance
Firmicutes Lachnospiraceae
|
0.026 relative abundance difference (%)
Standard Error 0.035
|
0.026 relative abundance difference (%)
Standard Error 0.050
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides uniformis
|
-0.016 relative abundance difference (%)
Standard Error 0.062
|
0.027 relative abundance difference (%)
Standard Error 0.071
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides vulgatus
|
-0.0260 relative abundance difference (%)
Standard Error 0.072
|
-0.158 relative abundance difference (%)
Standard Error 0.142
|
|
Change in Bacterial Abundance
Firmicutes Lachnospiraceae bacterium GAM79
|
0.0187 relative abundance difference (%)
Standard Error 0.049
|
-0.008 relative abundance difference (%)
Standard Error 0.064
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroides
|
-0.014 relative abundance difference (%)
Standard Error 0.047
|
-0.087 relative abundance difference (%)
Standard Error 0.074
|
|
Change in Bacterial Abundance
Actinobacteria Bifidobacterium adolescentis
|
0.009 relative abundance difference (%)
Standard Error 0.129
|
-0.051 relative abundance difference (%)
Standard Error 0.091
|
|
Change in Bacterial Abundance
Actinobacteria Bifidobacterium longum
|
0.114 relative abundance difference (%)
Standard Error 0.073
|
0.094 relative abundance difference (%)
Standard Error 0.091
|
|
Change in Bacterial Abundance
Actinobacteria Collinsella aerofaciens
|
0.075 relative abundance difference (%)
Standard Error 0.046
|
0.050 relative abundance difference (%)
Standard Error 0.068
|
|
Change in Bacterial Abundance
Bacteroidetes Bacteroidales
|
-0.034 relative abundance difference (%)
Standard Error 0.046
|
-0.117 relative abundance difference (%)
Standard Error 0.077
|
|
Change in Bacterial Abundance
Firmicutes Anaerobutyricum hallii
|
0.060 relative abundance difference (%)
Standard Error 0.037
|
0.065 relative abundance difference (%)
Standard Error 0.040
|
|
Change in Bacterial Abundance
Firmicutes Anaerostipes hadrus
|
0.013 relative abundance difference (%)
Standard Error 0.046
|
0.003 relative abundance difference (%)
Standard Error 0.050
|
|
Change in Bacterial Abundance
Firmicutes Blautia [Ruminococcus] gnavus
|
-0.025 relative abundance difference (%)
Standard Error 0.051
|
0.064 relative abundance difference (%)
Standard Error 0.049
|
|
Change in Bacterial Abundance
Firmicutes Blautia sp. SC05B48
|
0.0018 relative abundance difference (%)
Standard Error 0.070
|
0.060 relative abundance difference (%)
Standard Error 0.048
|
|
Change in Bacterial Abundance
Firmicutes Clostridiales
|
0.0089 relative abundance difference (%)
Standard Error 0.028
|
0.047 relative abundance difference (%)
Standard Error 0.038
|
|
Change in Bacterial Abundance
Firmicutes Faecalibacterium prausnitzii
|
-0.032 relative abundance difference (%)
Standard Error 0.041
|
-0.098 relative abundance difference (%)
Standard Error 0.102
|
|
Change in Bacterial Abundance
Firmicutes Roseburia intestinalis
|
0.012 relative abundance difference (%)
Standard Error 0.063
|
-0.040 relative abundance difference (%)
Standard Error 0.085
|
|
Change in Bacterial Abundance
Firmicutes Ruminococcus bicirculans
|
0.101 relative abundance difference (%)
Standard Error 0.101
|
0.042 relative abundance difference (%)
Standard Error 0.155
|
SECONDARY outcome
Timeframe: 8 weeksPercent change in plasma low-density lipoprotein cholesterol values from baseline to 8 weeks
Outcome measures
| Measure |
Rosuvastatin
n=32 Participants
rosuvastatin 20 mg daily for eight weeks
Rosuvastatin: rosuvastatin 20 mg daily or placebo for eight weeks
|
Placebo
n=13 Participants
placebo daily for eight weeks
Placebo: Matched placebo control
|
|---|---|---|
|
Change in LDL-C (mg/dl)
|
-38.8 % change from baseline
Interval -46.1 to -31.5
|
6.3 % change from baseline
Interval -3.2 to 15.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksconcentration of bile acids (nM)
Outcome measures
Outcome data not reported
Adverse Events
Rosuvastatin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rosuvastatin
n=32 participants at risk
rosuvastatin 20 mg daily for eight weeks
Rosuvastatin: rosuvastatin 20 mg daily or placebo for eight weeks
|
Placebo
n=13 participants at risk
placebo daily for eight weeks
Placebo: Matched placebo control
|
|---|---|---|
|
Infections and infestations
Covid 19
|
6.2%
2/32 • Number of events 5 • AE info collected from time of enrollment until end of participation (approximately 4 months)
Study period overlapped with the start of the covid-19 pandemic in 2020. Many reported adverse events were related to covid infections.
|
15.4%
2/13 • Number of events 4 • AE info collected from time of enrollment until end of participation (approximately 4 months)
Study period overlapped with the start of the covid-19 pandemic in 2020. Many reported adverse events were related to covid infections.
|
Additional Information
Dr. Sony Tuteja, PharmD, Research Assistant Professor of Medicine
University of Pennsylvania, Perelman School of Medicine
Phone: 215-615-8785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place