Trial Outcomes & Findings for A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes. (NCT NCT04153929)

Last Updated: 2022-11-29

Results Overview

Absolute change in glycosylated hemoglobin A1c (HbA1c) from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17. Absolute change from baseline in HbA1c to 16 weeks after treatment start was calculated by subtracting the baseline HbA1c value from the HbA1c value at Week 17.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

413 participants

Primary outcome timeframe

At baseline and at Week 17 (16 weeks after treatment start).

Results posted on

2022-11-29

Participant Flow

This was a randomized, multicenter placebo and active comparator controlled, double-blind within dose groups, parallel-group, 16-week trial in patients with type 2 diabetes mellitus (T2DM). An open-label arm (semaglutide) was included as benchmark to compare response curves and support assumptions for Phase III design.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Placebo This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Study STARTED	60	50	50	52	50	51	50	50
Overall Study Treated	59	50	50	52	50	51	49	50
Overall Study COMPLETED	49	41	45	36	33	45	37	45
Overall Study NOT COMPLETED	11	9	5	16	17	6	13	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Overall Study Other than listed	2	2	0	1	0	2	2	1
Overall Study Lost to Follow-up	2	1	0	1	1	0	0	0
Overall Study Withdrawal by Subject	3	1	0	3	1	0	1	0
Overall Study Protocol Violation	0	0	0	0	0	0	1	2
Overall Study Adverse Event	3	5	5	11	15	4	8	2
Overall Study Not treated	1	0	0	0	0	0	1	0

Baseline Characteristics

A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=59 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=52 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=51 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=49 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.	Total n=411 Participants Total of all reporting groups
Glycosylated hemoglobin A1c (HbA1c) measured in percentage units [%]	8.15 percentage of HbA1c STANDARD_DEVIATION 0.85 • n=5 Participants	8.09 percentage of HbA1c STANDARD_DEVIATION 0.76 • n=7 Participants	7.89 percentage of HbA1c STANDARD_DEVIATION 0.80 • n=5 Participants	8.14 percentage of HbA1c STANDARD_DEVIATION 0.86 • n=4 Participants	8.18 percentage of HbA1c STANDARD_DEVIATION 0.97 • n=21 Participants	8.11 percentage of HbA1c STANDARD_DEVIATION 0.94 • n=10 Participants	7.97 percentage of HbA1c STANDARD_DEVIATION 0.71 • n=115 Participants	8.03 percentage of HbA1c STANDARD_DEVIATION 0.82 • n=6 Participants	8.07 percentage of HbA1c STANDARD_DEVIATION 0.84 • n=6 Participants
Age, Continuous	57.5 Years STANDARD_DEVIATION 10.5 • n=5 Participants	56.1 Years STANDARD_DEVIATION 10.2 • n=7 Participants	58.2 Years STANDARD_DEVIATION 9.6 • n=5 Participants	55.3 Years STANDARD_DEVIATION 10.3 • n=4 Participants	59.6 Years STANDARD_DEVIATION 8.5 • n=21 Participants	58.3 Years STANDARD_DEVIATION 8.8 • n=10 Participants	57.7 Years STANDARD_DEVIATION 9.4 • n=115 Participants	55.8 Years STANDARD_DEVIATION 10.5 • n=6 Participants	57.3 Years STANDARD_DEVIATION 9.8 • n=6 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	25 Participants n=4 Participants	17 Participants n=21 Participants	24 Participants n=10 Participants	22 Participants n=115 Participants	16 Participants n=6 Participants	178 Participants n=6 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	26 Participants n=7 Participants	28 Participants n=5 Participants	27 Participants n=4 Participants	33 Participants n=21 Participants	27 Participants n=10 Participants	27 Participants n=115 Participants	34 Participants n=6 Participants	233 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	12 Participants n=21 Participants	10 Participants n=10 Participants	9 Participants n=115 Participants	14 Participants n=6 Participants	91 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants	39 Participants n=7 Participants	42 Participants n=5 Participants	40 Participants n=4 Participants	38 Participants n=21 Participants	41 Participants n=10 Participants	40 Participants n=115 Participants	36 Participants n=6 Participants	320 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=10 Participants	3 Participants n=115 Participants	5 Participants n=6 Participants	42 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=6 Participants	20 Participants n=6 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	42 Participants n=7 Participants	44 Participants n=5 Participants	42 Participants n=4 Participants	43 Participants n=21 Participants	41 Participants n=10 Participants	42 Participants n=115 Participants	43 Participants n=6 Participants	344 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants

PRIMARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start).

Population: Full Analysis Set (FAS): This patient set included all patients who were randomized and received at least one dose of study drug and who had analysable data for at least one efficacy endpoint. Only patients with non-missing results are reported.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=41 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=46 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=36 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=33 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=44 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=36 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=45 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Absolute Change in HbA1c From Baseline to 16 Weeks	-0.23 percentage (%) of HbA1c Standard Deviation 0.81	-0.91 percentage (%) of HbA1c Standard Deviation 0.71	-1.37 percentage (%) of HbA1c Standard Deviation 0.93	-1.79 percentage (%) of HbA1c Standard Deviation 0.92	-1.67 percentage (%) of HbA1c Standard Deviation 0.78	-1.68 percentage (%) of HbA1c Standard Deviation 0.90	-1.79 percentage (%) of HbA1c Standard Deviation 0.76	-1.50 percentage (%) of HbA1c Standard Deviation 0.84

SECONDARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start ).

The relative change in body weight from baseline to 16 weeks after treatment start is presented. The measurements for this outcome were performed at baseline and at Week 17. The relative change in body weight from baseline to 16 weeks after treatment start was calculated as (body weight at Week 17 - body weight at baseline/body weight at baseline) \* 100.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=41 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=46 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=36 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=33 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=44 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=37 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=45 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks	-1.20 percentage of body weight change Standard Deviation 3.52	-1.86 percentage of body weight change Standard Deviation 2.91	-4.43 percentage of body weight change Standard Deviation 3.92	-6.63 percentage of body weight change Standard Deviation 5.13	-6.68 percentage of body weight change Standard Deviation 4.05	-7.16 percentage of body weight change Standard Deviation 6.06	-8.95 percentage of body weight change Standard Deviation 5.33	-5.40 percentage of body weight change Standard Deviation 4.33

SECONDARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start).

The absolute change in body weight from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17. The absolute change in body weight from baseline to 16 weeks after treatment start was calculated as: body weight at Week 17- body weight at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=41 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=46 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=36 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=33 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=44 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=37 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=45 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
The Absolute Change in Body Weight From Baseline to 16 Weeks	-1.28 kilogram (kg) Standard Deviation 3.05	-1.90 kilogram (kg) Standard Deviation 3.12	-4.41 kilogram (kg) Standard Deviation 4.07	-6.31 kilogram (kg) Standard Deviation 4.53	-6.88 kilogram (kg) Standard Deviation 4.41	-6.75 kilogram (kg) Standard Deviation 6.10	-8.88 kilogram (kg) Standard Deviation 4.93	-5.18 kilogram (kg) Standard Deviation 4.52

SECONDARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start).

The absolute change in waist circumference from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17. The absolute change in waist circumference from baseline to 16 weeks after treatment start was calculated as: waist circumference at Week 17- waist circumference at baseline.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=43 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=47 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=39 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=35 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=45 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=36 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=46 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
The Absolute Change in Waist Circumference From Baseline to 16 Weeks	-1.95 centimeter Standard Deviation 9.08	-2.73 centimeter Standard Deviation 10.49	-1.80 centimeter Standard Deviation 10.55	-3.63 centimeter Standard Deviation 10.94	-7.47 centimeter Standard Deviation 12.24	-4.61 centimeter Standard Deviation 9.73	-12.89 centimeter Standard Deviation 25.50	-3.63 centimeter Standard Deviation 5.05

SECONDARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start).

The percentage of patients with 5 percent (%) or greater body weight loss from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=52 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=51 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=49 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks	6.8 percentage of patients	8.0 percentage of patients	38.0 percentage of patients	42.3 percentage of patients	46.0 percentage of patients	56.9 percentage of patients	57.1 percentage of patients	38.0 percentage of patients

SECONDARY outcome

Timeframe: At baseline and at Week 17 (16 weeks after treatment start).

The percentage of patients with 10 % or greater body weight loss from baseline to 16 weeks after treatment start is presented. Measurements for this outcome were performed at baseline and at Week 17.

Outcome measures

Outcome measures
Measure	Placebo n=59 Participants This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=52 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=51 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=49 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=50 Participants Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks	0.0 percentage of patients	2.0 percentage of patients	6.0 percentage of patients	13.5 percentage of patients	16.0 percentage of patients	25.5 percentage of patients	34.7 percentage of patients	16.0 percentage of patients

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

BI 456906 0.3 mg

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

BI 456906 0.9 mg

Serious events: 4 serious events

Other events: 30 other events

Deaths: 0 deaths

BI 456906 1.8 mg

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

BI 456906 2.7 mg

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

BI 456906 1.2 Twice Weekly (2.4) mg

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

BI 456906 1.8 Twice Weekly (3.6) mg

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Semaglutide

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=59 participants at risk This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=52 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=51 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=49 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Gastrointestinal disorders Abdominal pain	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Immune system disorders Autoimmune disorder	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Infections and infestations Viraemia	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Nervous system disorders IIIrd nerve paralysis	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Nervous system disorders Paraparesis	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Vascular disorders Hypotension	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo n=59 participants at risk This arm comprises all placebo treated patients, regardless of the dose group in which they were treated. Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered solution for subcutaneous injection of placebo matched to BI 456906 once weekly for 16 weeks or twice weekly for 16 weeks.	BI 456906 0.3 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1-Week 16.	BI 456906 0.9 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2, 0.6 mg on Week 3 and Week 4, 0.9 mg on Week 5-Week 16.	BI 456906 1.8 mg n=52 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1, 0.6 mg on Week 2, 0.9 mg on Week 3, 1.2 mg on Week 4, 1.5 mg on Week 5, and 1.8 mg on Week 6- Week 16.	BI 456906 2.7 mg n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of BI 456906 of 0.6 milligram (mg) on Week 1 and Week 2, 1.2 mg on Week 3 and Week 4, 1.8 mg on Week 5, 2.4 mg on Week 6, 2.7 mg on Week 7- Week 16.	BI 456906 1.2 Twice Weekly (2.4) mg n=51 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 and Week 2 (total weekly dose=0.6 mg), 0.6 mg on Week 3 and Week 4 (total weekly dose=1.2 mg), 0.9 mg on Week 5 and Week 6 (total weekly dose=1.8 mg), 1.2 mg on Week 7- Week 16 (total weekly dose 2.4 mg).	BI 456906 1.8 Twice Weekly (3.6) mg n=49 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered twice weekly subcutaneously a solution for injection of BI 456906 of 0.3 milligram (mg) on Week 1 (total weekly dose=0.6 mg), 0.6 mg on Week 2 (total weekly dose=1.2 mg), 0.9 mg on Week 3 (total weekly dose=1.8 mg), 1.2 mg on Week 4 (total weekly dose 2.4 mg), 1.5 mg on Week 5 and on Week 6 (total weekly dose 3 mg), 1.8 mg on Week 7 -Week 16 (total weekly dose =3.6 mg).	Semaglutide n=50 participants at risk Patients with type 2 diabetes mellitus with insufficient glycaemic control despite diet, exercise and metformin treatment were administered once weekly subcutaneously a solution for injection of Semaglutide of 0.25 milligram (mg) on Week 1-Week 4, 0.5 mg on Week 5-Week 8, 1.0 mg on Week 9-Week 16.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.7% 4/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.1% 2/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	3.4% 2/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	12.0% 6/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.2% 4/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	9.8% 5/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.1% 2/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	13.5% 7/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	14.0% 7/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	15.7% 8/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	10.2% 5/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	11.9% 7/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	24.0% 12/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	16.0% 8/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	17.3% 9/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	14.0% 7/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	15.7% 8/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	22.4% 11/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	10.0% 5/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	9.6% 5/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	14.3% 7/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Eructation	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Flatulence	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.7% 4/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Nausea	8.5% 5/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	20.0% 10/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	28.0% 14/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	48.1% 25/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	46.0% 23/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	27.5% 14/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	46.9% 23/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	12.0% 6/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Vomiting	5.1% 3/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	14.0% 7/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	18.0% 9/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	23.1% 12/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	26.0% 13/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	11.8% 6/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	22.4% 11/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
General disorders Asthenia	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.1% 2/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
General disorders Fatigue	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	10.2% 5/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.1% 3/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Infections and infestations Urinary tract infection	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.7% 4/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Investigations Lipase increased	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	11.8% 6/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.2% 4/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	3.4% 2/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	12.0% 6/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	14.0% 7/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	11.5% 6/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	22.0% 11/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	17.6% 9/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	30.6% 15/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	3.4% 2/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.1% 3/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	1.7% 1/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	6.1% 3/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.
Nervous system disorders Headache	6.8% 4/59 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	10.0% 5/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	7.7% 4/52 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	5.9% 3/51 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	10.2% 5/49 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days. Treated set (TS): This patient set included all patients who were randomized and received at least one dose of study drug.

Additional Information

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Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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