SYNCHRONIZE™-1

CompletedPhase 3

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

A Phase 3, Randomised, Double-blind, Parallel-group, 76-week, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Participants With Overweight or Obesity Without Type 2 Diabetes

Lead sponsor

Boehringer Ingelheim

Asset

Survodutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

118

Recruiting sites

—

Enrollment

726

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

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 IDNCT06066515

Org study ID1404-0038

Secondary ID2022-502529-17-00CTIS

Secondary IDU1111-1288-9400WHO registry

Timeline

Milestones

Study first posted2023-10-04actual

Study start2023-11-25actual

Primary completion2025-12-02actual

Study completion2026-02-20actual

Last update posted2026-03-12actual

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) ≥30 kg/m^2 at screening, OR BMI ≥27 kg/m^2 with the presence of at least one of the obesity-related complications (treated or untreated) e.g,:

–Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, systolic blood pressure (SBP) values of ≥140 millimetre of mercury (mmHg) and/or diastolic blood pressure (DBP) values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure)

–Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or low-density lipoprotein (LDL) cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or high-density lipoprotein (HDL) cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol 50 mg/dL (<1.3 mmol/L) for women)

–Obstructive sleep apnoea

–Others.

3. History of at least one self-reported unsuccessful dietary effort to lose body weight.

Further inclusion criteria apply.

Exclusion criteria

1. Body weight change (self-reported) of >5% within 3 months before screening.

2. Treatment with any medication for the indication obesity within 3 months before screening.

3. Glycosylated haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening.

4. History of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) or treatment with glucose lowering agent started within 3 months before the screening up to and including the randomisation visit.

5. Heart failure (HF) with New York Heart Association (NYHA) functional class IV.

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

7. History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening.

8. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).

Further exclusion criteria apply.

Endpoints (33)

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

Glycemic / diabetes

MASH / liver

Patient-reported / QoL

Weight & body composition

16 endpoints

Primary/protocol endpoint

Percentage change in body weight from baseline to Week 76

Time frame:Baseline and at Week 76

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76

Time frame:Baseline and at Week 76

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76

Time frame:Baseline and at Week 76

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76

Time frame:Baseline and at Week 76

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76

Time frame:Baseline and at Week 76

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in body weight (kg)

Time frame:Baseline and Week 76

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in waist circumference (cm)

Time frame:Baseline and at Week 76

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)

Time frame:Baseline and at Week 76

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in total fat volume (L)

Time frame:Baseline and at Week 76

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in lean body volume (L)

Time frame:Baseline and at Week 76

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in visceral fat volume (L)

Time frame:Baseline and at Week 76

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in subcutaneous fat volume (L)

Time frame:Baseline and at Week 76.

Subcutaneous fat, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 76 in total fat volume (%)

Time frame:Baseline and at Week 76

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 76 in lean body volume (%)

Time frame:Baseline and at Week 76

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 76 in visceral fat volume (%)

Time frame:Baseline and at Week 76

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change from baseline to Week 76 in subcutaneous fat volume (%)

Time frame:Baseline and at Week 76.

Subcutaneous fat, change

percent change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)

Time frame:Baseline and at Week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in HbA1c (mmol/mol)

Time frame:Baseline and at Week 76

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)

Time frame:Baseline and at Week 76

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)

Time frame:Baseline and at Week 76

change from baseline, improvement

MASH / liver

3 endpoints

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)

Time frame:Baseline and at Week 76

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)

Time frame:Baseline and at Week 76

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

Relative change from baseline to Week 76 in liver fat content (%)

Time frame:Baseline and at Week 76

Liver fat content, change

percent change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)

Time frame:Baseline and at Week 76

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)

Time frame:Baseline and at Week 76

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in total cholesterol (mg/dL)

Time frame:Baseline and at Week 76

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)

Time frame:Baseline and at Week 76

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)

Time frame:Baseline and at Week 76

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)

Time frame:Baseline and at Week 76

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in triglycerides (mg/dL)

Time frame:Baseline and at Week 76

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in free fatty acids (mg/dL)

Time frame:Baseline and at Week 76

Free fatty acids, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of the Eating Behaviour patient reported outcome (PRO)

Time frame:Baseline and at Week 76

change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline to Week 76 in Eating Behaviour PRO total score

Time frame:Baseline and at Week 76

change from baseline, improvement

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

Survodutide for treatment of obesity: Baseline characteristics of participants in a randomized, double-blind, placebo-controlled, phase 3 trial (SYNCHRONIZE™-1).
Diabetes, obesity & metabolism2026 Jan (month)PMID41187967doi:10.1111/dom.70196via clinicaltrials gov reference derived + pubmed nct search
Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE™-1 and -2).
Obesity (Silver Spring, Md.)2025 Jan (month)PMID39495965doi:10.1002/oby.24184via 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 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.