The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
751
Administered SC
Administered SC
Percent Change From Baseline in Body Weight
Percent change from baseline in body weight was reported. Least Squares (LS) mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 72
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of participants who achieved ≥10% body weight reduction (observed values) was reported.
Time frame: Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of participants who achieved ≥15% body weight reduction (observed values) was reported.
Time frame: Week 72
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Percentage of participants who achieved ≥20% body weight reduction (observed values) was reported.
Time frame: Week 72
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Percentage of participants who achieved ≥25% body weight reduction (observed values) was reported.
Time frame: Week 72
Change From Baseline in Waist Circumference in Centimeter
Change from baseline in waist circumference in centimeter was reported. LS mean was determined using ANCOVA model with Baseline + Baseline BMI Group 1 + Sex + Pre diabetes status at randomization + Treatment (Type III sum of squares) as variables.
Time frame: Baseline, Week 72
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
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Percentage of participants who achieved ≥30% body weight reduction (observed values) was reported.
Time frame: Week 72
Change From Baseline in Body Mass Index (BMI)
Change from baseline in BMI was reported. LS mean was determined using Mixed Model Repeated Measures (MMRM) model using Baseline + Sex + Pre diabetes status at randomization + Treatment + Time + Treatment\*Time(Type III sum of squares) as variables.
Time frame: Baseline, Week 72
Percent Change From Baseline in Body Weight Comparing 15 mg Tirzepatide and 2.4 mg Semaglutide
Percent change from baseline in body weight comparing 15mg of Tirzepatide and 2.4 mg Semaglutide was reported. The treatment effect for tirzepatide versus semaglutide for percent change in body weight was also evaluated assuming that participants had stayed on treatment and reached the highest dose of treatment. LS mean was determined by MMRM model using Baseline + Sex + Pre diabetes status at randomization + Baseline BMI Group 1 + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 72