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CompletedNCT04153929Updated Nov 29, 2022Results posted

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

A Phase 2 interventional study of BI 456906 and Placebo in Diabetes Mellitus, Type 2, sponsored by Boehringer Ingelheim. Completed at 80 sites in 14 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
413
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 413 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed and dated written informed consent in accordance with International conference on harmonization - Good clinical practice (ICH GCP) and local legislation.
  • Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
  • Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent.
  • Glycosylated hemoglobin A1c (HbA1c) 7.0%-10.0% (both inclusive) at screening.
  • Treatment with a stable dose of metformin ≥ 1000mg/day for at least 3 months prior to screening.
  • Body mass index (BMI) 25 kg/m2-50 kg/m2 (both inclusive) at screening.
  • Women of childbearing potential must be ready and able to use highly effective methods of birth control.

Exclusion criteria

Exclusion criteria:

  • Patients with type 1 diabetes.
  • Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening, or any previous exposure to BI 456906.
  • Any additional oral anti-hyperglycemic medication beyond metformin within 3 months prior to screening.
  • Use of insulin for glycemic control within 12 months prior to screening.
  • Resting Heart Rate >100 bpm or blood pressure ≥160/95 mmHg at screening.
  • A marked baseline prolongation of QT/QTc (Fridericia) interval or any other clinically significant Electrocardiogram (ECG) finding at screening.
  • Body weight change of +/- 5% or more in the past 3 months or on anti-obesity therapies at any time during the 6 months prior to screening.

  • Continuous oral pharmacotherapy to treat any clinical condition during the Trial. Following medications are allowed:

    • metformin, anti-hypertensives (any medication known to cause heart block or bradycardia such as beta-blockers, verapamil and diltiazem are excluded unless used to treat heart rate control or hypertension),
    • Hormone replacement therapy including thyroid hormone, lipid lowering, proton pump inhibitors, H2 blockers for Gastric esophageal reflux disease (GERD), analgesics,
    • sleep medications
    • antihistamines
    • selective Alpha receptor blocker for benign prostatic hyperplasia Patients must be on a stable dose for at least 3 months Prior to Screening
  • Any suicidal behavior in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-suicide severity rating scale (C-SSRS) in the past 3 months at screening.
  • Chronic or relevant acute infections.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • Further exclusion criteria apply.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
413 participants (actual)

Study arms

  • Experimental
    BI 456906 0.3 mg

    Drug: BI 456906

  • Experimental
    BI 456906 0.9 mg

    Drug: BI 456906

  • Experimental
    BI 456906 1.8 mg

    Drug: BI 456906

  • Experimental
    BI 456906 2.7 mg

    Drug: BI 456906

  • Experimental
    BI 456906 1.2 twice weekly (2.4) mg

    Drug: BI 456906

  • Experimental
    BI 456906 1.8 twice weekly (3.6) mg

    Drug: BI 456906

  • Active comparator
    Semaglutide

    Drug: Semaglutide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBI 456906

    Solution for Injection

  • DrugPlacebo

    Solution for Injection

  • DrugSemaglutide

    Solution for Injection

06

What researchers measure

Primary outcomes

  1. Absolute Change in HbA1c From Baseline to 16 Weeks

    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.

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

Secondary outcomes

  1. Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks

    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.

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

  2. The Absolute Change in Body Weight From Baseline to 16 Weeks

    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.

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

  3. The Absolute Change in Waist Circumference From Baseline to 16 Weeks

    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.

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

  4. Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks

    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.

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

  5. Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks

    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.

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

07

Results

Posted Nov 29, 2022

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.

Participant flow — Overall Study
MilestonePlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
Started6050505250515050
Treated5950505250514950
Completed4941453633453745
Not completed119516176135
Withdrew: Other than listed22010221
Withdrew: Lost to follow-up21011000
Withdrew: Withdrawal by subject31031010
Withdrew: Protocol violation00000012
Withdrew: Adverse event3551115482
Withdrew: Not treated10000010

Outcome measures

PrimaryAbsolute Change in HbA1c From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start).
Reported as:
Mean · percentage (%) of HbA1c
Absolute Change in HbA1c From Baseline to 16 Weeks
percentage (%) of HbA1cPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
Absolute Change in HbA1c From Baseline to 16 Weeks-0.23 ± 0.81-0.91 ± 0.71-1.37 ± 0.93-1.79 ± 0.92-1.67 ± 0.78-1.68 ± 0.90-1.79 ± 0.76-1.50 ± 0.84
Statistical analysis
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod linear model fit · p = <0.0001Model assumption: The maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Exponential model fit · p = <0.0001Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Emax 1 model fit · p = <0.0001Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Emax 2 model fit · p = <0.0001Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Sigmoid Emax model fit · p = <0.0001Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg · Mixed Model for Repeated Measures · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -0.76 · 95% CI -1.06 to -0.46Difference was calculated as BI 456906 0.3 mg - Placebo at Week 17.
  • Placebo vs BI 456906 0.9 mg · Mixed Model for Repeated Measures · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -1.31 · 95% CI -1.60 to -1.01Difference was calculated as BI 456906 0.9 mg - Placebo at Week 17.
  • Placebo vs BI 456906 1.8 mg · Mixed Model for Repeated Measures · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -1.56 · 95% CI -1.87 to -1.26Difference was calculated as BI 456906 1.8 mg - Placebo at Week 17.
  • Placebo vs BI 456906 2.7 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -1.41 · 95% CI -1.72 to -1.10Difference was calculated as BI 456906 2.7 mg - Placebo at Week 17.
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -1.49 · 95% CI -1.78 to -1.19Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -1.53 · 95% CI -1.84 to -1.22Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
SecondaryKey Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start ).
Reported as:
Mean · percentage of body weight change
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks
percentage of body weight changePlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
Key Secondary Endpoint: The Relative Change in Body Weight From Baseline to 16 Weeks-1.20 ± 3.52-1.86 ± 2.91-4.43 ± 3.92-6.63 ± 5.13-6.68 ± 4.05-7.16 ± 6.06-8.95 ± 5.33-5.40 ± 4.33
Statistical analysis
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod linear model fit · p = <0.0001Model assumption: The maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod exponential model fit · p = <0.0001Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Emax 1 model fit · p = <0.0001Model assumption: 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Emax 2 model fit · p = <0.0001Model assumption: 70% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg vs BI 456906 0.9 mg vs BI 456906 1.8 mg vs BI 456906 2.7 mg vs BI 456906 1.2 Twice Weekly (2.4) mg vs BI 456906 1.8 Twice Weekly (3.6) mg · MCP-Mod Sigmoid Emax model fit · p = <0.0001Model assumption: 50% of the maximum effect is achieved at 1.8 mg and 90% of the maximum effect is achieved at 3.6 mg dose.
  • Placebo vs BI 456906 0.3 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.2228 (P-value is considered nominal.) · Difference of adjusted means: -1.11 · 95% CI -2.90 to 0.68Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 0.9 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -3.79 · 95% CI -5.56 to -2.01Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -5.61 · 95% CI -7.41 to -3.81Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 2.7 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -6.25 · 95% CI -8.12 to -4.38Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -6.25 · 95% CI -8.02 to -4.47Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -7.68 · 95% CI -9.52 to -5.83Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
SecondaryThe Absolute Change in Body Weight From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start).
Reported as:
Mean · kilogram (kg)
The Absolute Change in Body Weight From Baseline to 16 Weeks
kilogram (kg)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
The Absolute Change in Body Weight From Baseline to 16 Weeks-1.28 ± 3.05-1.90 ± 3.12-4.41 ± 4.07-6.31 ± 4.53-6.88 ± 4.41-6.75 ± 6.10-8.88 ± 4.93-5.18 ± 4.52
Statistical analysis
  • Placebo vs BI 456906 0.3 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.4439 (P-value is considered nominal.) · Difference of adjusted means: -0.66 · 95% CI -2.34 to 1.03Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 0.9 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.0001 (P-value is considered nominal.) · Difference of adjusted means: -3.28 · 95% CI -4.95 to -1.61Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal) · Difference of adjusted means: -4.93 · 95% CI -6.62 to -3.23Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 2.7 mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -5.76 · 95% CI -7.53 to -4.00Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -5.44 · 95% CI -7.11 to -3.77Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Mixed Model for Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -7.05 · 95% CI -8.79 to -5.31Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
  • Placebo vs Semaglutide · Mixed Model Repeated Measures (MMRM) · p = <0.0001 (P-value is considered nominal.) · Difference of adjusted means: -3.85 · 95% CI -5.52 to -2.18Difference was calculated as "Semaglutide" - "Placebo" at Week 17.
SecondaryThe Absolute Change in Waist Circumference From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start).
Reported as:
Mean · centimeter
The Absolute Change in Waist Circumference From Baseline to 16 Weeks
centimeterPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
The Absolute Change in Waist Circumference From Baseline to 16 Weeks-1.95 ± 9.08-2.73 ± 10.49-1.80 ± 10.55-3.63 ± 10.94-7.47 ± 12.24-4.61 ± 9.73-12.89 ± 25.50-3.63 ± 5.05
Statistical analysis
  • Placebo vs BI 456906 0.3 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.7708 (P-value is considered nominal.) · Difference of adjusted means: -0.62 · 95% CI -4.82 to 3.57Difference was calculated as "BI 456906 0.3 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 0.9 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.7462 (P-value is considered nominal.) · Difference of adjusted means: 0.68 · 95% CI -3.44 to 4.79Difference was calculated as "BI 456906 0.9 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.1302 (P-value is considered nominal.) · Difference of adjusted means: -3.32 · 95% CI -7.62 to 0.98Difference was calculated as "BI 456906 1.8 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 2.7 mg · Mixed Model for Repeated Measures (MMRM) · p = 0.0414 (P-value is considered nominal.) · Difference of adjusted means: -4.61 · 95% CI -9.03 to -0.18Difference was calculated as "BI 456906 2.7 mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Mixed Model for Repeated Measures (MMRM) · p = 0.2273 (P-value is considered nominal.) · Difference of adjusted means: -2.55 · 95% CI -6.71 to 1.60Difference was calculated as "BI 456906 1.2 twice weekly (2.4) mg" - "Placebo" at Week 17.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Mixed Model for Repeated Measures (MMRM) · p = 0.0002 (P-value is considered nominal.) · Difference of adjusted means: -8.40 · 95% CI -12.81 to -3.98Difference was calculated as "BI 456906 1.8 twice weekly (3.6) mg" - "Placebo" at Week 17.
  • Placebo vs Semaglutide · Mixed Model Repeated Measures (MMRM) · p = 0.1967 (P-value is considered nominal.) · Difference of adjusted means: -2.72 · 95% CI -6.86 to 1.42Difference was calculated as "Semaglutide" - "Placebo" at Week 17.
SecondaryPercentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start).
Reported as:
Number · percentage of patients
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks
percentage of patientsPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
Percentage of Patients With 5 % or Greater Body Weight Loss From Baseline to 16 Weeks6.88.038.042.346.056.957.138.0
Statistical analysis
  • Placebo vs BI 456906 0.3 mg · Odds ratio (or): 1.22 · 95% CI 0.28 to 5.20Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 0.9 mg · Odds ratio (or): 7.92 · 95% CI 2.43 to 25.74Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 1.8 mg · Odds ratio (or): 17.68 · 95% CI 5.21 to 60.03Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 2.7 mg · Odds ratio (or): 25.87 · 95% CI 7.31 to 91.55Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Odds ratio (or): 21.75 · 95% CI 6.57 to 72.04Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Odds ratio (or): 35.00 · 95% CI 9.84 to 124.47Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs Semaglutide · Odds ratio (or): 8.22 · 95% CI 2.52 to 26.79Odds Ratio was calculated as Semaglutide / Placebo.
SecondaryPercentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks

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.

Time frame:
At baseline and at Week 17 (16 weeks after treatment start).
Reported as:
Number · percentage of patients
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks
percentage of patientsPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
Percentage of Patients With 10% or Greater Body Weight Loss From Baseline to 16 Weeks0.02.06.013.516.025.534.716.0
Statistical analysis
  • Placebo vs BI 456906 0.3 mg · Odds ratio (or): 3.67 · 95% CI 0.14 to 95.73Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 0.9 mg · Odds ratio (or): 7.97 · 95% CI 0.39 to 163.56Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 1.8 mg · Odds ratio (or): 25.17 · 95% CI 1.35 to 471.09Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 2.7 mg · Odds ratio (or): 33.01 · 95% CI 1.78 to 613.51
  • Placebo vs BI 456906 1.2 Twice Weekly (2.4) mg · Odds ratio (or): 42.44 · 95% CI 2.37 to 761.44Odds Ratio was calculated as BI 456906 / Placebo.
  • Placebo vs BI 456906 1.8 Twice Weekly (3.6) mg · Odds ratio (or): 84.53 · 95% CI 4.71 to 999Odds Ratio was calculated as BI 456906 / Placebo. The upper limit is bigger than 999.
  • Placebo vs Semaglutide · Odds ratio (or): 22.44 · 95% CI 1.22 to 413.33Odds Ratio was calculated as Semaglutide / Placebo.

Adverse events

Collected over From first intake of any trial drug until last intake of any trial drug (planned: 16 weeks) + residual effect period (BI 456906: 28 days, Semaglutide: 35 days), up to 159 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/59 (0%)3/59 (5.1%)18/59 (30.5%)
BI 456906 0.3 mg0/50 (0%)1/50 (2%)27/50 (54%)
BI 456906 0.9 mg0/50 (0%)4/50 (8%)30/50 (60%)
BI 456906 1.8 mg0/52 (0%)3/52 (5.8%)40/52 (76.9%)
BI 456906 2.7 mg0/50 (0%)2/50 (4%)33/50 (66%)
BI 456906 1.2 Twice Weekly (2.4) mg0/51 (0%)1/51 (2%)33/51 (64.7%)
BI 456906 1.8 Twice Weekly (3.6) mg0/49 (0%)0/49 (0%)37/49 (75.5%)
Semaglutide0/50 (0%)0/50 (0%)20/50 (40%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
CellulitisInfections and infestations0/590/502/500/520/500/510/490/50
Abdominal painGastrointestinal disorders0/591/500/500/520/500/510/490/50
DiarrhoeaGastrointestinal disorders0/590/500/500/521/500/510/490/50
Irritable bowel syndromeGastrointestinal disorders0/590/501/500/520/500/510/490/50
Mouth ulcerationGastrointestinal disorders0/590/501/500/520/500/510/490/50
VomitingGastrointestinal disorders0/591/500/500/520/500/510/490/50
Autoimmune disorderImmune system disorders0/590/501/500/520/500/510/490/50
ViraemiaInfections and infestations0/590/500/500/521/500/510/490/50
Pharyngeal ulcerationRespiratory, thoracic and mediastinal disorders0/590/501/500/520/500/510/490/50
ArthralgiaMusculoskeletal and connective tissue disorders0/590/500/500/520/501/510/490/50
Most frequent other events
Showing 10 of 22
Most frequent other events
EventPlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutide
NauseaGastrointestinal disorders5/5910/5014/5025/5223/5014/5123/496/50
Decreased appetiteMetabolism and nutrition disorders2/596/507/506/5211/509/5115/493/50
VomitingGastrointestinal disorders3/597/509/5012/5213/506/5111/492/50
DiarrhoeaGastrointestinal disorders7/5912/508/509/527/508/5111/495/50
ConstipationGastrointestinal disorders0/593/502/507/527/508/515/493/50
DyspepsiaGastrointestinal disorders0/594/503/505/524/504/517/491/50
Abdominal distensionGastrointestinal disorders2/593/501/501/526/502/514/491/50
Weight decreasedInvestigations0/590/501/502/520/506/514/491/50
FatigueGeneral disorders0/593/501/503/522/504/515/491/50
HeadacheNervous system disorders4/594/505/504/521/503/515/490/50

Baseline characteristics

Treated set (TS): TS included all patients who were randomized and received at least one dose of study drug.

Age, Continuous
Age, Continuous(Years)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutideTotal
Mean57.5 ± 10.556.1 ± 10.258.2 ± 9.655.3 ± 10.359.6 ± 8.558.3 ± 8.857.7 ± 9.455.8 ± 10.557.3 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutideTotal
Female2824222517242216178
Male3126282733272734233
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutideTotal
Hispanic or Latino1511812121091491
Not Hispanic or Latino4439424038414036320
Unknown or Not Reported000000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutideTotal
American Indian or Alaska Native010000102
Asian8458453542
Native Hawaiian or Other Pacific Islander100000001
Black or African American3312243220
White4742444243414243344
More than one race000000000
Unknown or Not Reported000011002
Glycosylated hemoglobin A1c (HbA1c) measured in percentage units [%]
Glycosylated hemoglobin A1c (HbA1c) measured in percentage units [%](percentage of HbA1c)PlaceboBI 456906 0.3 mgBI 456906 0.9 mgBI 456906 1.8 mgBI 456906 2.7 mgBI 456906 1.2 Twice Weekly (2.4) mgBI 456906 1.8 Twice Weekly (3.6) mgSemaglutideTotal
Mean8.15 ± 0.858.09 ± 0.767.89 ± 0.808.14 ± 0.868.18 ± 0.978.11 ± 0.947.97 ± 0.718.03 ± 0.828.07 ± 0.84
08

Study locations

80 sites
  • National Research Institute
    Huntington Park, California 90255, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • Valley Clinical Trials, Inc.
    Northridge, California 91325, United States
  • Indago Research and Health Center
    Hialeah, Florida 33012, United States
  • Meridien Research
    Lakeland, Florida 33803, United States
  • San Marcus Research Clinic, Inc.
    Miami, Florida 33014, United States
  • Renstar Medical Research
    Ocala, Florida 34470, United States
  • Sensible Healthcare, LLC
    Ocoee, Florida 34761, United States
  • Meridien Research
    Saint Petersburg, Florida 33709, United States
  • In-Quest Medical Research, LLC
    Suwanee, Georgia 30024, United States
  • Solaris Clinical Research
    Meridian, Idaho 83646, United States
  • DuPage Medical Group, Ltd
    Lombard, Illinois 60148, United States
  • Iowa Diabetes and Endocrinology Research Center
    West Des Moines, Iowa 50265, United States
  • ActivMed Practices & Research
    Methuen, Massachusetts 01844, United States
  • StudyMetrix Research, LLC
    Saint Peters, Missouri 63303, United States
  • Mercury Street Medical
    Butte, Montana 59701, United States
  • Palm Research Center
    Las Vegas, Nevada 89148, United States
  • The University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • PMG Research of Hickory, LLC
    Hickory, North Carolina 28602, United States
  • Lucas Research, Inc.
    Morehead City, North Carolina 28557, United States
  • PMG Research of Raleigh, LLC
    Raleigh, North Carolina 27609, United States
  • PMG Research of Piedmont Healthcare
    Statesville, North Carolina 28625, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • PMG Research of Winston-Salem
    Winston-Salem, North Carolina 27103, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Lillestol Research, LLC
    Fargo, North Dakota 58104, United States
  • Heritage Valley Medical Group
    Beaver, Pennsylvania 15009, United States
  • PMG Research of Knoxville
    Knoxville, Tennessee 37938, United States
  • Dallas Diabetes and Endocrine Center
    Dallas, Texas 75230, United States
  • Clinical Trials of Texas, LLC
    San Antonio, Texas 78229, United States
  • Javara Research
    Sugar Land, Texas 77478, United States
  • Boden Institute of Obesity, Nutrition, Exercies and Eating Disorders
    Camperdown, New South Wales 2006, Australia
  • Hunter Diabetes Centre
    Merewether, New South Wales 2291, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Monash University
    Box Hill, Victoria 3128, Australia
  • Austin Health
    Heidelberg, Victoria 3081, Australia
  • Baker Heart and Diabetes Institute
    Melbourne, Victoria 3004, Australia
  • AKH - Medical University of Vienna
    Vienna, 1090, Austria
  • KH Rudolfstiftung, 1. Med. Abt., Wien
    Wien, 1030, Austria
  • Cook Street Medical Clinic
    Victoria, British Columbia V8V 4A1, Canada
  • LMC Clinical Research Inc. (Brampton)
    Brampton, Ontario L6S 0C6, Canada
  • LMC Clinical Research Inc. (Thornhill)
    Concord, Ontario L4K 4M2, Canada
  • The Wharton Medical Clinic Clinical Trials Inc.
    Hamilton, Ontario L8L 5G8, Canada
  • Devonshire Clinical Research Inc.
    Woodstock, Ontario N4S 5P5, Canada
  • Manna Research (Quebec)
    Levis, Quebec G6W 0M5, Canada
  • Centre Medical Acadie
    Montreal, Quebec H4N 2W2, Canada
  • Manna Research (Montreal)
    Pointe-Claire, Quebec H9R 4S3, Canada
  • Edumed s.r.o
    Broumov, 55001, Czechia
  • General Faculty Hospital, Prague
    Prague 2, 128 08, Czechia
  • Studienzentrum Aschaffenburg
    Aschaffenburg, 63739, Germany
  • InnoDiab Forschung GmbH
    Essen, 45136, Germany
  • Institut für Diabetesforschung Münster GmbH
    Münster, 48145, Germany
  • DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured
    Balatonfured, 8230, Hungary
  • Bajcsy-Zsilinszky Hospital and Clinic
    Budapest, 1106, Hungary
  • University Debrecen Hospital
    Debrecen, 4032, Hungary
  • The Catholic University of Korea, Bucheon St.Mary's Hospital
    Bucheon, 14647, Korea, Republic of
  • Dongguk University Ilsan Hospital
    Goyang, 10326, Korea, Republic of
  • Kangdong Sacred Heart Hospital
    Seoul, 134701, Korea, Republic of
  • Optimal Clinical Trials
    Auckland, 1010, New Zealand
  • P3 Research
    Newtown Wellington NZ, 6021, New Zealand
  • P3 Research Kapiti
    Paraparaumu, 5032, New Zealand
  • P3 Research
    Tauranga, 3110, New Zealand
  • In-Vivo Sp. Z o.o.
    Bydgoszcz, 85-048, Poland
  • Vita Longa Sp. z o.o.
    Katowice, 40-748, Poland
  • Pratia SA
    Skorzewo, 60-185, Poland
  • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun
    Torun, 87-100, Poland
  • NBR Polska
    Warsaw, 00-465, Poland
  • GCM Medical Group, PSC
    San Juan, 00917, Puerto Rico
  • Hospital A Coruña
    A Coruña, 15006, Spain
  • C.A.P. Sardenya
    Barcelona, 08025, Spain
  • Hospital Virgen de la Victoria
    Malaga, 29010, Spain
  • Hospital Clínico de Valencia
    Valencia, 46010, Spain
  • Chang-Hua Christian Hospital
    Changhua, 500, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital
    Kaohsiung, 83301, Taiwan
  • Chung Shan Medical University Hospital
    Taichung, 40201, Taiwan
  • Waterloo Medical Centre
    Blackpool, FY4 3AD, United Kingdom
  • Burbage Surgery
    Burbage, Hinkley, LE10 2SE, United Kingdom
  • White Horse Medical Practice
    Faringdon, SN7 7YU, United Kingdom
  • Clifton Medical Centre, Rotherham
    Rotherham, S65 1DA, United Kingdom
  • Moorgreen Hospital
    Southampton, SO30 3JB, United Kingdom
09

References and documents

Related links

Study documents

  • Study protocol · Sep 28, 2020
  • Statistical analysis plan · Nov 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04153929
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Nov 6, 2019
Start date
Apr 30, 2020
Primary completion
Oct 8, 2021
Completion
Nov 4, 2021
Results posted
Nov 29, 2022
Last update
Nov 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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