A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight

Percentage Change in Body Weight From Baseline to Week 46

Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Percentage change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures, an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. That is, a hypothetical strategy was used for intercurrent event (ICE) "COVID-19 pandemic-related early treatment discontinuation", a treatment policy strategy for ICE "non-pandemic-related early treatment discontinuation".

Weight Loss of ≥ 5% of Baseline Weight at Week 46

Time frame · At baseline and at Week 46.

Weight loss of greater than or equal to 5 percent (≥5%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥5% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.

Weight Loss of ≥ 10% of Baseline Weight at Week 46

Time frame · At baseline and at Week 46.

Weight loss of greater than or equal to 10 percent (≥10%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥10% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.

Weight Loss of ≥ 15% of Baseline Weight at Week 46

Time frame · At baseline and at Week 46.

Weight loss of greater than or equal to 15 percent (≥15%) of baseline weight at Week 46 (yes/no), reported as percentage of participants who achieved a weight loss of ≥15% of baseline weight at Week 46. For analysis, all available post-baseline body weight measurements (on- and off-treatment) were used, except those for participants who discontinued treatment early due to COVID-19. For these participants only on-treatment values were used. Percentages were rounded to one decimal place.

Absolute Change in Body Weight From Baseline to Week 46

Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Absolute change in body weight from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline body weight as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.

Absolute Change in Waist Circumference From Baseline to Week 46

Time frame · Baseline, Week 6, 12, 18, 24, 32, 40, and 46.

Absolute change in waist circumference from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline waist circumference as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit (Week 6, 12, 18, 24, 32, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.

Absolute Change in Systolic Blood Pressure From Baseline to Week 46

Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Absolute change in systolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline systolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.

Absolute Change in Diastolic Blood Pressure From Baseline to Week 46

Time frame · Baseline, Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46.

Absolute change in diastolic blood pressure from baseline to Week 46 was modeled using a mixed model for repeated measures (MMRM) with fixed effects for baseline diastolic blood pressure as a continuous linear covariate, and treatment, gender, visit, treatment by visit interaction and baseline by visit interaction as factors, using visit Week 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, and 46) as repeated measures and an unstructured covariance matrix to model within subject measurements, adjusted mean (standard error) at Week 46 is reported. MMRM analysis was performed on the FAS, using planned maintenance treatment (dose assigned at randomisation) and including only on-treatment data, regardless of whether early treatment discontinuation was COVID-19 related.