DelfaGLP-1 Atlas

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Active not recruitingPhase 3

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

A Phase 3, Randomised, Double-blind, Parallel-group, Event-driven, Cardiovascular Safety Study With BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity With Established Cardiovascular Disease (CVD) or Chronic Kidney Disease, and/or at Least Two Weight-related Complications or Risk Factors for CVD

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

540

Recruiting sites

—

Enrollment

5,531

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•Established CVD

Primary endpoint

•5-point MACE (Cardiovascular death, Non-fatal stroke, Non-fatal MI, Coronary revascularization)

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 IDNCT06077864
Org study ID1404-0040
Secondary ID2022-502442-27-00CTIS
Secondary IDU1111-1289-0174WHO registry

Timeline

Milestones

Study first posted2023-10-11actual
Study start2023-11-20actual
Primary completion2026-05-08actual
Last update posted2026-05-29actual
Study completion2026-06-22estimated

Assets

Investigational agents

Survodutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years.

2. Body mass index (BMI) ≥27 kg/m2 at screening with established cardiovascular disease (CVD) and/or at least 2 weight-related complications or risk factors for CVD OR BMI ≥30 kg/m2 at screening with established CVD or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

Further inclusion criteria apply.

Exclusion criteria

1. Previous treatment with glucagon-like peptide-1 receptor (GLP-1R) agonists within 3 months before screening.

2. Type 1 diabetes.

3. Less than 3 months between the last dose of GLP-1R agonists and GLP-1R agonist/insulin/glucose-dependent insulinotropic polypeptide (GIP) combinations and screening.

4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).

Further exclusion criteria apply.

Endpoints (28)

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

Cardiovascular outcomes
13
Weight & body composition
5
Glycemic / diabetes
3
Heart failure
3
MASH / liver
2
Cardiometabolic biomarkers
2

Cardiovascular outcomes

13 endpoints
Primary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate non-inferiority)

Time frame:up to Week 114

5-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI, Coronary revascularization, Heart-failure hospitalization

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3-point major adverse cardiac event (3P-MACE)) (to demonstrate non-inferiority)

Time frame:up to Week 114

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, ischaemia related coronary revascularisation, or HFE (to demonstrate superiority)

Time frame:up to Week 114

5-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI, Coronary revascularization, Heart-failure hospitalization

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or ischaemia related coronary revascularisation (4-point major adverse cardiac event (4P-MACE))

Time frame:up to Week 114

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI, Coronary revascularization

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, non-fatal MI, or HFE (3P-MACE+ HFE)

Time frame:up to Week 114

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI, Heart-failure hospitalization

Secondary/protocol endpoint

Time to first occurrence of any of the adjudicated components of the composite endpoint consisting of: CV death, non-fatal stroke, or non-fatal MI (3P-MACE)

Time frame:up to Week 114

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal stroke, Non-fatal MI

Secondary/protocol endpoint

Time to first occurrence of adjudicated CV death or adjudicated HFE

Time frame:up to Week 114

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization

Secondary/protocol endpoint

Time to first occurrence of adjudicated CV death or adjudicated HHF

Time frame:up to Week 114

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Heart-failure hospitalization

Secondary/protocol endpoint

Time to adjudicated CV death

Time frame:up to Week 114

Cardiovascular death

time to event, event

Secondary/protocol endpoint

Time to all-cause mortality

Time frame:up to Week 114

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

Time to first occurrence of adjudicated non-fatal MI

Time frame:up to Week 114

Non-fatal MI

time to event, event

SNOMED 22298006

Secondary/protocol endpoint

Time to first occurrence of adjudicated non-fatal stroke

Time frame:up to Week 114

Non-fatal stroke

time to event, event

SNOMED 230690007

Secondary/protocol endpoint

Time to first occurrence of adjudicated ischaemia related coronary revascularisation

Time frame:up to Week 114

Coronary revascularization

time to event, event

SNOMED 415070008

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Absolute change in waist circumference (cm) from baseline to Week 72

Time frame:Baseline and at Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage change in body weight from baseline to Week 72

Time frame:Baseline and at Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥5% from baseline to Week 72

Time frame:Baseline and at Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥10% from baseline to Week 72

Time frame:Baseline and at Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥15% from baseline to Week 72

Time frame:Baseline and at Week 72

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Absolute change in glycosylated haemoglobin A1c (HbA1c) (mmol/mol) from baseline to Week 72 in trial participants with type 2 diabetes mellitus (T2DM)

Time frame:Baseline and at Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change in HbA1c (%) from baseline to Week 72 in trial participants with T2DM

Time frame:Baseline and at Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time to onset of T2DM in trial participants without T2DM at baseline

Time frame:up to Week 114

Time to T2DM onset

time to event, event

MASH / liver

2 endpoints
Secondary/protocol endpoint

Absolute change in aspartate aminotransferase (AST) (U/L) from baseline to Week 72

Time frame:Baseline and at Week 72

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Absolute change in alanine aminotransferase (ALT) (U/L) from baseline to Week 72

Time frame:Baseline and at Week 72

ALT, change

change from baseline, improvement

LOINC 1742-6

Heart failure

3 endpoints
Secondary/protocol endpoint

Absolute change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Week 72 in trial participants with HF at baseline

Time frame:At Baseline and at Week 72

change from baseline, improvement

Secondary/protocol endpoint

Time to first occurrence of adjudicated HFE

Time frame:up to Week 114

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

A composite of death, number of adjudicated HFEs, time to first adjudicated HFE and change from baseline in KCCQ-TSS at 72 weeks assessed by the win ratio in trial participants with HF at baseline

Time frame:At baseline and at 72 Weeks

Heart-failure composite

composite event, event

componentsAll-cause death, Heart-failure hospitalization, KCCQ total score

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 72

Time frame:Baseline and at Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Absolute change in diastolic blood pressure (DBP) (mmHg) from baseline to Week 72

Time frame:Baseline and at Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.