GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

A Phase II, Randomized, Parallel Group, Dose-finding Study of Subcutaneously Administered BI 456906 for 16 Weeks, Compared With Placebo and Open-label Semaglutide in Patients With Type 2 Diabetes Mellitus.

Lead sponsor

Boehringer Ingelheim

Assets

Semaglutide / Survodutide

Listed sites

Recruiting sites

—

Enrollment

413

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-50•HbA1c 7-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04153929

Org study ID1404-0002

Secondary ID2019-002390-60

Timeline

Milestones

Study first posted2019-11-06actual

Study start2020-04-30actual

Primary completion2021-10-08actual

Study completion2021-11-04actual

Last update posted2022-11-29actual

Results first posted2022-11-29actual

Assets

Investigational agents

Semaglutide Survodutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

•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.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Weight & body composition

10 endpoints

Secondary/registry result

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

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

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percentage of body weight change	95% CI
Placebo	-1.20	—
BI 456906 0.3 mg	-1.86	—
BI 456906 0.9 mg	-4.43	—
BI 456906 1.8 mg	-6.63	—
BI 456906 2.7 mg	-6.68	—
BI 456906 1.2 Twice Weekly (2.4) mg	-7.16	—
BI 456906 1.8 Twice Weekly (3.6) mg	-8.95	—
Semaglutide	-5.40	—

p<0.0001MCP-Mod linear model fit

p<0.0001MCP-Mod exponential model fit

p<0.0001MCP-Mod Emax 1 model fit

p<0.0001MCP-Mod Emax 2 model fit

p<0.0001MCP-Mod Sigmoid Emax model fit

Difference of adjusted means-1.1195% CI-2.90 – 0.68p0.2228Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-3.7995% CI-5.56 – -2.01p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-5.6195% CI-7.41 – -3.81p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-6.2595% CI-8.12 – -4.38p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-6.2595% CI-8.02 – -4.47p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-7.6895% CI-9.52 – -5.83p<0.0001Mixed Model for Repeated Measures (MMRM)

Secondary/registry result

The Absolute Change in Body Weight From Baseline to 16 Weeks

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram (kg)	95% CI
Placebo	-1.28	—
BI 456906 0.3 mg	-1.90	—
BI 456906 0.9 mg	-4.41	—
BI 456906 1.8 mg	-6.31	—
BI 456906 2.7 mg	-6.88	—
BI 456906 1.2 Twice Weekly (2.4) mg	-6.75	—
BI 456906 1.8 Twice Weekly (3.6) mg	-8.88	—
Semaglutide	-5.18	—

Difference of adjusted means-0.6695% CI-2.34 – 1.03p0.4439Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-3.2895% CI-4.95 – -1.61p0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-4.9395% CI-6.62 – -3.23p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-5.7695% CI-7.53 – -4.00p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-5.4495% CI-7.11 – -3.77p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-7.0595% CI-8.79 – -5.31p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-3.8595% CI-5.52 – -2.18p<0.0001Mixed Model Repeated Measures (MMRM)

Secondary/registry result

The Absolute Change in Waist Circumference From Baseline to 16 Weeks

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

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeter	95% CI
Placebo	-1.95	—
BI 456906 0.3 mg	-2.73	—
BI 456906 0.9 mg	-1.80	—
BI 456906 1.8 mg	-3.63	—
BI 456906 2.7 mg	-7.47	—
BI 456906 1.2 Twice Weekly (2.4) mg	-4.61	—
BI 456906 1.8 Twice Weekly (3.6) mg	-12.89	—
Semaglutide	-3.63	—

Difference of adjusted means-0.6295% CI-4.82 – 3.57p0.7708Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means0.6895% CI-3.44 – 4.79p0.7462Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-3.3295% CI-7.62 – 0.98p0.1302Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-4.6195% CI-9.03 – -0.18p0.0414Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-2.5595% CI-6.71 – 1.60p0.2273Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-8.4095% CI-12.81 – -3.98p0.0002Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-2.7295% CI-6.86 – 1.42p0.1967Mixed Model Repeated Measures (MMRM)

Secondary/registry result

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

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

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	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	—

Odds Ratio (OR)1.2295% CI0.28 – 5.20

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)7.9295% CI2.43 – 25.74

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)17.6895% CI5.21 – 60.03

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)25.8795% CI7.31 – 91.55

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)21.7595% CI6.57 – 72.04

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)35.0095% CI9.84 – 124.47

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Odds Ratio (OR)8.2295% CI2.52 – 26.79

Method: Logistic regression model for body weight loss with treatment as fixed effect.

Secondary/registry result

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

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

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of patients	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	—

Odds Ratio (OR)3.6795% CI0.14 – 95.73

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)7.9795% CI0.39 – 163.56

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)25.1795% CI1.35 – 471.09

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)33.0195% CI1.78 – 613.51

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)42.4495% CI2.37 – 761.44

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)84.5395% CI4.71 – 999

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Odds Ratio (OR)22.4495% CI1.22 – 413.33

Method: Logistic regression model using Firth's bias-reducing penalized maximum likelihood estimation for body weight loss with treatment as fixed effect.

Secondary/protocol endpoint

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

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

The Absolute Change in Body Weight From Baseline to 16 Weeks

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

The Absolute Change in Waist Circumference From Baseline to 16 Weeks

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

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

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Absolute Change in HbA1c From Baseline to 16 Weeks

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage (%) of HbA1c	95% CI
Placebo	-0.23	—
BI 456906 0.3 mg	-0.91	—
BI 456906 0.9 mg	-1.37	—
BI 456906 1.8 mg	-1.79	—
BI 456906 2.7 mg	-1.67	—
BI 456906 1.2 Twice Weekly (2.4) mg	-1.68	—
BI 456906 1.8 Twice Weekly (3.6) mg	-1.79	—
Semaglutide	-1.50	—

p<0.0001MCP-Mod linear model fit

p<0.0001MCP-Mod Exponential model fit

p<0.0001MCP-Mod Emax 1 model fit

p<0.0001MCP-Mod Emax 2 model fit

p<0.0001MCP-Mod Sigmoid Emax model fit

Difference of adjusted means-0.7695% CI-1.06 – -0.46p<0.0001Mixed Model for Repeated Measures

Difference of adjusted means-1.3195% CI-1.60 – -1.01p<0.0001Mixed Model for Repeated Measures

Difference of adjusted means-1.5695% CI-1.87 – -1.26p<0.0001Mixed Model for Repeated Measures

Difference of adjusted means-1.4195% CI-1.72 – -1.10p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-1.4995% CI-1.78 – -1.19p<0.0001Mixed Model for Repeated Measures (MMRM)

Difference of adjusted means-1.5395% CI-1.84 – -1.22p<0.0001Mixed Model for Repeated Measures (MMRM)

Primary/protocol endpoint

Absolute Change in HbA1c From Baseline to 16 Weeks

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Dose-response effects on HbA(1c) and bodyweight reduction of survodutide, a dual glucagon/GLP-1 receptor agonist, compared with placebo and open-label semaglutide in people with type 2 diabetes: a randomised clinical trial.
Diabetologia2024 Mar (month)PMID38095657doi:10.1007/s00125-023-06053-9via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.