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Trial · NCT06317051

Registered outcomes25

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

ListOutcomeTime frameDescription
PrimaryTo assess the impact of dapagliflozin vs. placebo on weight reduction24 weeksMean reduction change in body weight across treatment arms at 24 weeks, defined as absolute body weight change.
PrimaryTo assess the impact of pitavastatin vs. rosuvastatin/ezetimibe on low-density lipoproteins (LDL) concentration24 weeksMean change in LDL as absolute change from baseline to 24 weeks across treatment arms
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on body mass index (BMI )- weight and height will be combined to report BMI in kg/m^248 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to hip (cm) ratio48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on waist (cm) to height (cm) ratio48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on systolic and diastolic blood pressure (mm Hg)48 weeks
Secondary
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
48 weeks
Secondary
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on fasting glucose (mmol/L)48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on haemoglobin A1C (%)48 weeks
Secondary
To assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on measures of fatty liver disease: Liver Function Tests - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L), FibroScan (kPa)
48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)48 weeks
SecondaryTo assess the impact of dapagliflozin vs. placebo from baseline to 48 weeks on Serious adverse events.48 weeks
Secondary
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on fasting lipids including: Total Cholesterol (mmol/L), LDL (mmol/L), High-Density Lipoproteins (HDL) (mmol/L), Triglycerides (mmol/L)
48 weeks
Secondary
To assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on Atherosclerotic cardiovascular disease risk score (ASCVD) - calculation of a person's10-year risk (%) of having a cardiovascular problem.
48 weeks
SecondaryTo assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on inflammatory biomarkers (tested centrally on stored research samples)48 weeks
SecondaryTo assess the impact of pitavastatin vs. rosuvastatin/ezetimibe from baseline to 48 weeks on serious adverse events48 weeks
OtherChange in body weight from baseline to Week 96Baseline to Week 96Absolute change in body weight, measured in kilograms, from baseline to Week 96.
OtherChange in waist-to-hip and waist-to-height ratios from baseline to Week 96Baseline to Week 96Change in waist-to-hip ratio and waist-to-height ratio from baseline to Week 96.
OtherChange in systolic and diastolic blood pressure from baseline to Week 96Baseline to Week 96Change in resting systolic and diastolic blood pressure, measured in mmHg, from baseline to Week 96.

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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