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Trial · NCT04657016

Registered outcomes22

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

ListOutcomeTime frameDescription
PrimaryPercent Change From Baseline in Body WeightBaseline, 72 Weeks
Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
PrimaryPercentage of Participants With Greater Than or Equal to (≥) 5% Body Weight ReductionWeek 72Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.
SecondaryPercentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program72 Weeks
Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
SecondaryPercentage of Participants Who Achieve ≥10%Body Weight Reduction72 WeeksPercentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
SecondaryPercentage of Participants Who Achieve ≥15% Body Weight Reduction72 WeeksPercentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
SecondaryPercentage of Participants Who Achieve ≥20% Body Weight Reduction72 WeeksPercentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
SecondaryChange From Baseline in Waist CircumferenceBaseline, 72 Weeks
Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Body WeightBaseline, 72 Weeks
Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Body Mass Index (BMI)Baseline, 72 Weeks
Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Systolic Blood Pressure (SBP)Baseline, 72 Weeks
Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Diastolic Blood Pressure (DBP)Baseline, 72 Weeks
Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in Total CholesterolBaseline, 72 Weeks
Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in High Density Lipoprotein (HDL) CholesterolBaseline, 72 Weeks
Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in Low Density Lipoprotein (LDL) CholesterolBaseline, 72 Weeks
Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in Very Low-Density Lipoprotein (VLDL) CholesterolBaseline, 72 Weeks
Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in TriglyceridesBaseline, 72 Weeks
Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in Free Fatty AcidsBaseline, 72 Weeks
Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Fasting GlucoseBaseline, 72 Weeks
Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryChange From Baseline in Hemoglobin A1c (HbA1c)Baseline, 72 Weeks
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
SecondaryPercent Change From Baseline in Fasting InsulinBaseline, 72 Weeks
Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).

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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