← Trials/Trial dossier/NCT06066528
SYNCHRONIZE™-2
CompletedPhase 3A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also 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 and Type 2 Diabetes Mellitus
Lead sponsor
Asset
Survodutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
143
Recruiting sites
—
Enrollment
755
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≥27•HbA1c ≥6.5%
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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/m^2 at screening.
3. Diagnosed with Type 2 diabetes mellitus (T2DM) (defined as Glycosylated haemoglobin A1c (HbA1c) ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening.
4. HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening.
5. Currently treated for T2DM with either diet and exercise alone or stable treatment (for at least 3 months prior to screening) per treatment guidelines.
6. 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. Treatment with any medication for indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il).
4. Known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction).
5. History of either chronic or acute pancreatitis or elevation of serum lipase or amylase >2x upper limit of normal (ULN)) as measured by the central laboratory at screening.
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
Further exclusion criteria apply.
Endpoints (24)
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
8 endpointsPercentage change in body weight from baseline to Week 76
Time frame:Baseline and at Week 76
Body weight, % change
percent change from baseline, improvement
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
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
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
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
Absolute change from baseline to Week 76 in body weight (kg)
Time frame:Baseline and at Week 76
Body weight, absolute change (kg)
change from baseline, improvement
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
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
Glycemic / diabetes
4 endpointsAbsolute 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
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
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
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
2 endpointsAbsolute 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
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
Cardiometabolic biomarkers
8 endpointsAbsolute 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
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
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
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
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
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
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
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 endpointsAbsolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)
Time frame:Baseline and at Week 76
change from baseline, improvement
Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score
Time frame:Baseline and at Week 76
PGI, change
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
- Diabetes, obesity & metabolism2026 Feb (month)PMID41216778doi:10.1111/dom.70263via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.