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Trial · NCT02290106

Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

NCT02290106, Not applicable, Completed, Massachusetts General Hospital; results first posted 2019-07-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects of Pitavastatin on Insulin Sensitivity and Liver Fat. Trials, record NCT02290106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02290106

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects of Pitavastatin on Insulin Sensitivity and Liver Fat
NCT number
NCT02290106
Status
Completed
Phases
Not applicable
Enrollment
50 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
Obesity, Fatty Liver, Nonalcoholic
Interventions
pitavastatin, PLACEBO
First posted
2014-11-13
Last updated
2019-07-02
Results first posted
2019-07-02

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryInsulin-stimulated Glucose Uptake6 monthsinsulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp
PrimaryLiver Fat6 monthsliver fat content as measured by 1H-magnetic resonance spectroscopy
SecondaryAlanine Aminotransferase (ALT)6 monthsalanine aminotransferase at the 6 month timepoint
SecondaryAspartate Aminotransferase (AST)6 monthsaspartate aminotransferase at 6 month timepoint
SecondaryHepatic Insulin Sensitivity6 monthshepatic insulin sensitivity assessed by glucose infusion rate corrected for fluctuations in serum glucose ("M") during low-dose insulin clamp
SecondaryHemoglobin A1c (HbA1c)6 months
SecondaryQuantitative Insulin Sensitivity Check Index (QUICKI)6 monthsquantitative insulin sensitivity check index (QUICKI) at 6 months. Measure = 1/((log(glucose in mg/dL) + log(insulin in uU/mL))

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYInsulin-stimulated Glucose Uptake6 monthsAll patients with results for baseline and final. In addition to 3 participants who did not finish the study, 2 participants were unable to undergo clamp.mg/kg/minuteMEAN
PRIMARYLiver Fat6 months
All participants with baseline and final data were analyzed. In addition to patients who discontinued from the study, some patients were unable to have MRI scan due to inability to fit in the scanner or unanticipated claustrophobia.
% liver fat (hepatic fat fraction)MEAN
SECONDARYAlanine Aminotransferase (ALT)6 monthsall patients with available data at baseline and finalU/LMEAN
SECONDARYAspartate Aminotransferase (AST)6 monthsall patients with available data at baseline and finalU/LMEAN
SECONDARYHepatic Insulin Sensitivity6 monthsall patients with available data at baseline and final (note, in addition to 3 patients who discontinued, some patients were unable to undergo clamp procedure)mg/kg/minuteMEAN
SECONDARYHemoglobin A1c (HbA1c)6 months% (hemoglobin A1c)MEAN
SECONDARYQuantitative Insulin Sensitivity Check Index (QUICKI)6 monthsQUICKI indexMEAN

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Insulin-stimulated Glucose UptakePitavastatin5.9Standard Deviation 2.1mg/kg/minute
Insulin-stimulated Glucose UptakePlacebo5.9Standard Deviation 1.6mg/kg/minute
Liver FatPitavastatin17Standard Deviation 11% liver fat (hepatic fat fraction)
Liver FatPlacebo14Standard Deviation 10% liver fat (hepatic fat fraction)
Alanine Aminotransferase (ALT)Pitavastatin37Standard Deviation 38U/L
Alanine Aminotransferase (ALT)Placebo27Standard Deviation 17U/L
Aspartate Aminotransferase (AST)Pitavastatin31Standard Deviation 23U/L
Aspartate Aminotransferase (AST)Placebo26Standard Deviation 12U/L
Hepatic Insulin SensitivityPitavastatin1.5Standard Deviation 1.0mg/kg/minute
Hepatic Insulin SensitivityPlacebo1.6Standard Deviation 0.7mg/kg/minute

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPitavastatin25
Overall StudySTARTEDPlacebo25
Overall StudyCOMPLETEDPitavastatin24
Overall StudyCOMPLETEDPlacebo23
Overall StudyNOT COMPLETEDPitavastatin1
Overall StudyNOT COMPLETEDPlacebo2

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDiarrhea or Loose StoolsGastrointestinal disordersPitavastatin325
otherDiarrhea or Loose StoolsGastrointestinal disordersPlacebo725
otherAny Gastrointestinal SymptomsGastrointestinal disordersPitavastatin525
otherAny Gastrointestinal SymptomsGastrointestinal disordersPlacebo825
otherAny Musculoskeletal SymptomsMusculoskeletal and connective tissue disordersPitavastatin425
otherAny Musculoskeletal SymptomsMusculoskeletal and connective tissue disordersPlacebo625
otherMuscle CrampsMusculoskeletal and connective tissue disordersPitavastatin425
otherMuscle CrampsMusculoskeletal and connective tissue disordersPlacebo425
otherFatigueGeneral disordersPitavastatin225
otherFatigueGeneral disordersPlacebo525

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPitavastatin025
Total, all-cause mortalityPlacebo025
Total, other adverse eventsPitavastatin1625
Total, other adverse eventsPlacebo2525
Total, serious adverse eventsPitavastatin225
Total, serious adverse eventsPlacebo125

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30239757DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Pitavastatin vs Placebo: deaths from any causeTrial comparisons
Pitavastatin vs Placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02290106

GET https://conductscience.org/api/trials/v1/NCT02290106/registered