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Trial · NCT04095104

Outcomes28

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEnrollment Rate6 monthspercentage of participantsNUMBER
PRIMARYDropout Rate24 monthspercentage who withdrew among enrolledNUMBER
PRIMARYNumber of Participants Adherent to Study Drugs12 weeksThe one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYFrequency of Adverse Events24 monthsThe one participant randomized to the placebo group who withdrew before taking a single dose of study medication was not included in this outcome.unique adverse events per participantMEAN
SECONDARYPercent BMI ChangeBaseline and 12 weekspercent changeMEAN
SECONDARYPercent Weight ChangeBaseline and 12 weekspercent changeMEAN
SECONDARYChange in BMI Percent of the 95th%IleBaseline and 12 weeks
For 1 member of the active group and 2 members of the placebo group, it was not appropriate to calculate a % above the 95th%ile either because BMI was \<95th%ile or they were \>19 completed years at the time point.
percentile changeMEAN
SECONDARYChange in Heart RateBaseline and 12 weeksbeats per minuteMEAN
SECONDARYChange in Systolic Blood PressureBaseline and 12 weeksmmHgMEAN
SECONDARYChange in Diastolic Blood PressureBaseline and 12 weeksmmHgMEAN
SECONDARYChange in Total Cholesterol (mg/dL)Baseline and 12 weeksmg/dLMEAN
SECONDARYChange in Triglycerides (mg/dL)Baseline and 12 weeksmg/dLMEAN
SECONDARYChange in LDL Cholesterol (mg/dL)Baseline and 12 weeksmg/dLMEAN
SECONDARYChange in HDL Cholesterol (mg/dL)Baseline and 12 weeksmg/dLMEAN
SECONDARYChange in Alanine Aminotransferase (ALT) (U/L)Baseline and 12 weeksU/LMEAN
SECONDARYChange in Hemoglobin A1c (HbA1c) (%)Baseline and 12 weeksPercentage of glycated hemoglobinMEAN
SECONDARYChange in % Fat MassBaseline and 12 weekspercentage of fat massMEAN
SECONDARYChange in Resting Metabolic Rate (RMR)Baseline and 12 weekskilocalories per dayMEAN
SECONDARYChange in Daily Kilocalorie IntakeBaseline and 12 weekskilocaloriesMEAN
SECONDARYChange in HungerBaseline and 12 weeksVAS hunger ratings were missing from 1 participant in each the active and placebo groupsunits on a scaleMEAN

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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