Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Absolute Change in HbA1c From Baseline to 16 WeeksPrimary· At baseline and at Week 17 (16 weeks after treatment start).
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.
Group
Value
95% CI
Placebo
-0.23
± 0.81
BI 456906 0.3 mg
-0.91
± 0.71
BI 456906 0.9 mg
-1.37
± 0.93
BI 456906 1.8 mg
-1.79
± 0.92
BI 456906 2.7 mg
-1.67
± 0.78
BI 456906 1.2 Twice Weekly (2.4) mg
-1.68
± 0.90
BI 456906 1.8 Twice Weekly (3.6) mg
-1.79
± 0.76
Semaglutide
-1.50
± 0.84
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 WeeksSecondary· 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.
Group
Value
95% CI
Placebo
-1.20
± 3.52
BI 456906 0.3 mg
-1.86
± 2.91
BI 456906 0.9 mg
-4.43
± 3.92
BI 456906 1.8 mg
-6.63
± 5.13
BI 456906 2.7 mg
-6.68
± 4.05
BI 456906 1.2 Twice Weekly (2.4) mg
-7.16
± 6.06
BI 456906 1.8 Twice Weekly (3.6) mg
-8.95
± 5.33
Semaglutide
-5.40
± 4.33
The Absolute Change in Body Weight From Baseline to 16 WeeksSecondary· 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.
Group
Value
95% CI
Placebo
-1.28
± 3.05
BI 456906 0.3 mg
-1.90
± 3.12
BI 456906 0.9 mg
-4.41
± 4.07
BI 456906 1.8 mg
-6.31
± 4.53
BI 456906 2.7 mg
-6.88
± 4.41
BI 456906 1.2 Twice Weekly (2.4) mg
-6.75
± 6.10
BI 456906 1.8 Twice Weekly (3.6) mg
-8.88
± 4.93
Semaglutide
-5.18
± 4.52
The Absolute Change in Waist Circumference From Baseline to 16 WeeksSecondary· 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.
Group
Value
95% CI
Placebo
-1.95
± 9.08
BI 456906 0.3 mg
-2.73
± 10.49
BI 456906 0.9 mg
-1.80
± 10.55
BI 456906 1.8 mg
-3.63
± 10.94
BI 456906 2.7 mg
-7.47
± 12.24
BI 456906 1.2 Twice Weekly (2.4) mg
-4.61
± 9.73
BI 456906 1.8 Twice Weekly (3.6) mg
-12.89
± 25.50
Semaglutide
-3.63
± 5.05
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 WeeksSecondary· 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.
Group
Value
95% CI
Placebo
6.8
BI 456906 0.3 mg
8.0
BI 456906 0.9 mg
38.0
BI 456906 1.8 mg
42.3
BI 456906 2.7 mg
46.0
BI 456906 1.2 Twice Weekly (2.4) mg
56.9
BI 456906 1.8 Twice Weekly (3.6) mg
57.1
Semaglutide
38.0
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 WeeksSecondary· 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.
Group
Value
95% CI
Placebo
0.0
BI 456906 0.3 mg
2.0
BI 456906 0.9 mg
6.0
BI 456906 1.8 mg
13.5
BI 456906 2.7 mg
16.0
BI 456906 1.2 Twice Weekly (2.4) mg
25.5
BI 456906 1.8 Twice Weekly (3.6) mg
34.7
Semaglutide
16.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is open to adults with type 2 diabetes who take metformin but still have too high blood sugar. The purpose of the study is to find the best dose of BI 456906 that reduces blood sugar. The study also looks at whether BI 456906 helps the participants lose weight.
Participants are in the study for about 23 weeks. During this time, most participants visit the study site about 13 times. Some participants visit the study site about 20 times. At the start of the study, the participants are put into 7 groups. The participants in groups 1 to 6 get injections under the skin once or twice every week. Some participants get different doses of BI 456906 and other participants get placebo. Placebo injections look like the BI 456906 injections, but contain no medicine. Participants in group 7 get semaglutide injections every week. Semaglutide is another medicine for adults with type 2 diabetes.
During the study, the doctors regularly take blood samples from the participants and measure their body weight. The changes in blood sugar levels and body weight are compared between the groups. The doctors also check the general health of the participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05202353 — A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity
· Phase 1
· recruiting
NCT06352411 — A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
· Phase 1
· completed
NCT06352424 — A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain A
· Phase 1
· completed
NCT06200467 — A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesit
· Phase 1
· completed
NCT05896384 — A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contr
· Phase 1
· completed
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· recruiting
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 29 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04153929.