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Trial · NCT05934110

Registered outcomes35

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

ListOutcomeTime frameDescription
SecondaryAbsolute change from baseline in fasting high-density lipoprotein (HDL)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting low-density lipoprotein (LDL)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting triglycerides (TGs)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting Apolipoprotein A1 (ApoA1)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting Apolipoprotein B (ApoB)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting high sensitivity C-reacting protein (hs-CRP)Baseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in fasting albuminBaseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in homeostatic model assessment (HOMA) indexBaseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in Visceral adiposity index (VAI)Baseline and week 26Efficacy endpoints VAI Males = (WC/(39.38+(1.88\*BMI)))\*(TG/1.03)\*(1.31/HDL) VAI Females = (WC/(36.58+(1.89\*BMI)))\*(TG/0.81)\*(1.52/HDL)
SecondaryAbsolute change from baseline in Fatty liver index (FLI)Baseline and week 26Efficacy endpoints. Measured as FLI = 100\*e to the power of y /(1+e to the power of y) y= 0.953\*ln(TG)+0,139\*BMI+0.718\*ln(GGT)+0.053\*WC-15.3745
SecondaryAbsolute change from baseline in systolic and diastolic blood pressureBaseline and week 26Efficacy endpoints
SecondaryAbsolute change from baseline in heart rateBaseline and week 26Efficacy endpoints
SecondaryTolerability, assessed by conventional adverse event (AE) reporting (with special focus on oily spotting and fecal incontinence)IMP administration until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)Safety \& tolerability endpoints
SecondaryNumber of withdrawals from study (total and gastrointestinal [GI] related)Visit 1 until the end-of-study visit. Assessed at all nine visits (both outpatient and telephone visits)Safety \& tolerability endpoints
SecondaryAbsolute change from baseline in fasting liver enzymesBaseline and week 26Safety \& tolerability endpoints (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and gamma-glutamyl transferase)

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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