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Trial · NCT02666664

Outcomes30

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants With Treatment-emergent Adverse Events (TEAEs)Up to approximately 52 weeks
Safety Population: all randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group that they received, regardless of their randomized treatment.
percentage of participantsNUMBER
PRIMARYPercentage of Participants With Adjudicated Major Adverse Cardiovascular EventUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Creatine Kinase ElevationsUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Hepatic DisordersUp to approximately 52 weeks
Safety Population. The percentage of unique participants is reported in the Overall hepatic disorder AESIs category; a participant could have been represented in more than one of the individual hepatic disorder AESIs.
percentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: HypoglycemiaUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Metabolic AcidosisUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Muscular DisorderUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Neurocognitive DisorderUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes MellitusUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYPercentage of Participants With the Indicated Event of Special Interest: Renal DisorderUp to approximately 52 weeksSafety Populationpercentage of participantsNUMBER
PRIMARYChange From Baseline to Week 52 in Uric Acid (Urate) LevelBaseline and Week 52Safety Population. Only participants with available data were analyzed.milligrams per deciliter (mg/dL)MEAN
PRIMARYChange From Baseline to Week 52 in Creatinine LevelBaseline and Week 52Safety Population. Only participants with available data were analyzed.mg/dLMEAN
PRIMARYChange From Baseline to Week 52 in Hemoglobin LevelBaseline and Week 52Safety Population. Only participants with available data were analyzed.grams per deciliter (g/dL)MEAN
SECONDARYPercent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)Baseline; Week 12Full Analysis Set: all randomized participantspercent changeLEAST_SQUARES_MEAN
SECONDARYAbsolute Change From Baseline to Week 12 in LDL-CBaseline; Week 12Full Analysis Set. Only participants with available data were analyzed.mg/dLMEAN
OTHER_PRE_SPECIFIEDPercent Change From Baseline to Week 24 in LDL-CBaseline; Week 24Full Analysis Setpercent changeLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDPercent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)Baseline; Week 12Full Analysis Setpercent changeLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDPercent Change From Baseline to Week 12 in Total Cholesterol (TC)Baseline; Week 12Full Analysis Setpercent changeLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDPercent Change From Baseline to Week 12 in Apolipoprotein B (apoB)Baseline; Week 12Full Analysis Set. Only participants with available data were analyzed.percent changeLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDPercent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)Baseline; Week 12Full Analysis Set. Only participants with available data were analyzed.percent changeLEAST_SQUARES_MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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