GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

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

A Phase II, Randomized, Double Blind, Parallel Group,46 Weeks Dose-finding Study of BI 456906 Administered Once Weekly Subcutaneously Compared With Placebo in Patients With Obesity or Overweight

Lead sponsor

Boehringer Ingelheim

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

387

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Body weight, % 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 IDNCT04667377

Org study ID1404-0036

Secondary ID2020-002479-37

Timeline

Milestones

Study first posted2020-12-14actual

Study start2021-03-08actual

Primary completion2022-09-15actual

Study completion2022-10-07actual

Last update posted2023-11-02actual

Results first posted2023-11-02actual

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adult ≥ 18 years and < 75 years of age at screening

•Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

•Obesity or Overweight defined as BMI ≥27 kg/m2 at screening

•A minimum absolute body weight of 70 kg for females and 80 kg for males at screening

•Male or female participants. Women of childbearing potential (WOCBP)1 must be willing and able to use two forms of effective contraception where at least one form is highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.

•Patients must have undergone at least one previous unsuccessful nonsurgical weight-loss attempt per investigator's judgement

Exclusion criteria

•Body weight change of over +/- 5% or more in the past 12 weeks prior to randomization. There must be documentation of weight in the past 12 weeks before randomization.

•Obesity induced by an endocrinologic disorder (i.e. Cushing Syndrome, hypogonadism, growh hormone deficiency. However, well controlled hypothyroidism, polycystic ovarian disease are still allowed)

•A HbA1c ≥ 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus

•Exposure to Glucagon like peptide-1 receptor agonist (GLP-1Ra) based therapies within three months prior to screening

•Any suicidal behaviour in the past 2 years, any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (CSSRS) within 3 months before screening, or during screening period

•History of major depressive disorder within 2 years before randomization

•Major depressive symptoms (defined as a screening Patient Health Questionnaire-9 [PHQ-9] score ≥15) at screening and/or during screening period

•Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders at screening

•Chronic or relevant acute infections (including but not limited to respiratory tract infections, urinary tract infection, bladder infection, enterocolitis, abscess, tuberculosis, meningitis, influenza, Epstein-Barr virus, HIV/AIDS, and hepatitis B or C, and severe acute respiratory syndrome coronavirus type 19 (SARS CoV-2) (as confirmed by Polychain reaction (PCR) test)), within 2 weeks from screening or during screening.

•Further exclusion criteria apply

Endpoints (16)

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

Cardiometabolic biomarkers

Weight & body composition

12 endpoints

Primary/registry result

Percentage Change in Body Weight From Baseline to Week 46

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

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Percentage change	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	-6.19	—
2.4 mg BI 456906 - Planned Maintenance Treatment	-12.51	—
3.6 mg BI 456906 - Planned Maintenance Treatment	-13.22	—
4.8 mg BI 456906 - Planned Maintenance Treatment	-14.94	—
Placebo	-2.82	—

p<0.0001MCP-Mod - Linear model fit

p<0.0001MCP-Mod - Exponential model fit

p<0.0001MCP-Mod - Emax1 model fit

p<0.0001MCP-Mod - Emax2 model fit

p<0.0001MCP-Mod - Sigmoid Emax model fit

Difference of adjusted means-3.3795% CI-6.33 – -0.41p0.0257Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-9.6995% CI-12.57 – -6.81p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-10.4095% CI-13.32 – -7.49p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-12.1295% CI-15.00 – -9.24p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Primary/protocol endpoint

Percentage Change in Body Weight From Baseline to Week 46

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

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

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

Time frame:At baseline and at Week 46.

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	60.7	—
2.4 mg BI 456906 - Planned Maintenance Treatment	81.0	—
3.6 mg BI 456906 - Planned Maintenance Treatment	82.0	—
4.8 mg BI 456906 - Planned Maintenance Treatment	82.8	—
Placebo	25.9	—

Odds Ratio (OR)3.2895% CI1.57 – 6.84p0.0015Regression, Logistic

Odds Ratio (OR)8.8395% CI4.00 – 19.46p<.0001Regression, Logistic

Odds Ratio (OR)7.4895% CI3.41 – 16.41p<.0001Regression, Logistic

Odds Ratio (OR)10.7795% CI4.77 – 24.31p<.0001Regression, Logistic

Secondary/registry result

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

Time frame:At baseline and at Week 46.

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	33.9	—
2.4 mg BI 456906 - Planned Maintenance Treatment	65.5	—
3.6 mg BI 456906 - Planned Maintenance Treatment	65.6	—
4.8 mg BI 456906 - Planned Maintenance Treatment	68.8	—
Placebo	11.1	—

Odds Ratio (OR)3.2295% CI1.29 – 8.02p0.0120Regression, Logistic

Odds Ratio (OR)10.6295% CI4.36 – 25.86p<.0001Regression, Logistic

Odds Ratio (OR)9.7895% CI4.02 – 23.79p<.0001Regression, Logistic

Odds Ratio (OR)14.5095% CI5.91 – 35.55p<.0001Regression, Logistic

Secondary/registry result

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

Time frame:At baseline and at Week 46.

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of particpants	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	12.5	—
2.4 mg BI 456906 - Planned Maintenance Treatment	37.9	—
3.6 mg BI 456906 - Planned Maintenance Treatment	45.9	—
4.8 mg BI 456906 - Planned Maintenance Treatment	54.7	—
Placebo	5.6	—

Odds Ratio (OR)2.1395% CI0.56 – 8.02p0.2654Regression, Logistic

Odds Ratio (OR)9.4795% CI2.89 – 30.95p0.0002Regression, Logistic

Odds Ratio (OR)11.7995% CI3.62 – 38.36p<.0001Regression, Logistic

Odds Ratio (OR)21.0295% CI6.47 – 68.28p<.0001Regression, Logistic

Secondary/registry result

Absolute Change in Body Weight From Baseline to Week 46

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilogram (kg)	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	-7.21	—
2.4 mg BI 456906 - Planned Maintenance Treatment	-14.75	—
3.6 mg BI 456906 - Planned Maintenance Treatment	-15.64	—
4.8 mg BI 456906 - Planned Maintenance Treatment	-18.47	—
Placebo	-2.68	—

Difference of adjusted means-4.5395% CI-7.44 – -1.61p0.0025Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-12.0795% CI-14.94 – -9.19p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-12.9695% CI-15.85 – -10.07p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-15.7895% CI-18.67 – -12.90p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Secondary/registry result

Absolute Change in Waist Circumference From Baseline to Week 46

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

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centimeter (cm)	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	-8.32	—
2.4 mg BI 456906 - Planned Maintenance Treatment	-14.99	—
3.6 mg BI 456906 - Planned Maintenance Treatment	-14.96	—
4.8 mg BI 456906 - Planned Maintenance Treatment	-16.01	—
Placebo	-3.96	—

Difference of adjusted means-4.3695% CI-7.74 – -0.98p0.0116Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-11.0395% CI-14.39 – -7.66p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-11.0095% CI-14.33 – -7.67p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-12.0595% CI-15.39 – -8.71p<.0001Mixed Models Analysis

No formal hypotheses were tested.

Secondary/protocol endpoint

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

Time frame:At baseline and at Week 46.

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:At baseline and at Week 46.

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:At baseline and at Week 46.

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute Change in Body Weight From Baseline to Week 46

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute Change in Waist Circumference From Baseline to Week 46

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

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/registry result

Absolute Change in Systolic Blood Pressure From Baseline to Week 46

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), Millimeter of mercury (mmHg)	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	-6.19	—
2.4 mg BI 456906 - Planned Maintenance Treatment	-8.08	—
3.6 mg BI 456906 - Planned Maintenance Treatment	-8.66	—
4.8 mg BI 456906 - Planned Maintenance Treatment	-8.62	—
Placebo	-2.46	—

Difference of adjusted means-3.7395% CI-7.82 – 0.35p0.0733Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-5.6295% CI-9.71 – 1.53p<.0072Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-6.2095% CI-10.23 – -2.17p0.0027Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-6.1695% CI-10.25 – -2.06p0.0033Mixed Models Analysis

No formal hypotheses were tested.

Secondary/registry result

Absolute Change in Diastolic Blood Pressure From Baseline to Week 46

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), Millimeter of mercury (mmHg)	95% CI
0.6 mg BI 456906 - Planned Maintenance Treatment (Maintenance Dose Assigned at Randomisation)	-3.31	—
2.4 mg BI 456906 - Planned Maintenance Treatment	-4.36	—
3.6 mg BI 456906 - Planned Maintenance Treatment	-4.31	—
4.8 mg BI 456906 - Planned Maintenance Treatment	-4.80	—
Placebo	-1.87	—

Difference of adjusted means-1.4495% CI-3.92 – 1.05p0.2569Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-2.4995% CI-4.97 – -0.00p0.0495Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-2.4495% CI-4.90 – 0.01p0.0506Mixed Models Analysis

No formal hypotheses were tested.

Difference of adjusted means-2.9395% CI-5.40 – -0.46p0.0202Mixed Models Analysis

No formal hypotheses were tested.

Secondary/protocol endpoint

Absolute Change in Systolic Blood Pressure From Baseline to Week 46

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Absolute Change in Diastolic Blood Pressure From Baseline to Week 46

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Publications (2)

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

Subgroup analysis by sex and baseline BMI in people with a BMI ≥27 kg/m(2) in the phase 2 trial of survodutide, a glucagon/GLP-1 receptor dual agonist.
Diabetes, obesity & metabolism2025 Apr (month)PMID39821928doi:10.1111/dom.16167via clinicaltrials gov reference derived + pubmed nct search
Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.
The lancet. Diabetes & endocrinology2024 Mar (month)PMID38330987doi:10.1016/S2213-8587(23)00356-Xvia 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.