This is a study of LY3437943 in participants who have obesity or are overweight. The main purpose is to learn more about how LY3437943 affects body weight loss. The study will last about 18 months and may include up to 18 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
338
Mean Percent Change From Baseline in Body Weight
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 24
Mean Percent Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 48
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kilograms per square meter (kg/m2), ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Time frame: Week 24
Percentage of Participants Who Achieve ≥ 5% Body Weight Reduction
Percentage of participants who achieve ≥ 5% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Time frame: Week 48
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
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Scottsdale, Arizona, United States
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Anaheim, California, United States
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Fresno, California, United States
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Huntington Park, California, United States
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Los Angeles, California, United States
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Santa Ana, California, United States
Coastal Metabolic Research Centre
Ventura, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
...and 18 more locations
Time frame: Week 24
Percentage of Participants Who Achieve ≥ 10% Body Weight Reduction
Percentage of participants who achieve ≥ 10% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Time frame: Week 48
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Time frame: Week 24
Percentage of Participants Who Achieve ≥ 15% Body Weight Reduction
Percentage of participants who achieve ≥ 15% body weight reduction in LY3437943 relative to placebo. Estimated percentage was determined by logistic regression model with an intercept term, treatment group, baseline BMI stratum \[\<36 kg/m2, ≥36 kg/m2\] and sex \[female, male\] as fixed effects, and baseline body weight as a covariate.
Time frame: Week 48
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 24
Mean Change From Baseline in Body Weight
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 48
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 24
Mean Change From Baseline in BMI
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 48
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 24
Mean Change From Baseline in Waist Circumference
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment\*Time + Baseline BMI (\< 36kg/m2 vs. \>=36 kg/m2)\*Time + Sex (Female vs. Male)\*Time + Baseline\*Time.
Time frame: Baseline, Week 48