Abstract 4365838: Survodutide for the Treatment of Obesity: Baseline characteristics of the SYNCHRONIZE Cardiovascular Outcomes Trial
Bibliographic record
Abstract
Background: Dual agonism of glucagon and glucagon-like peptide-1 (GLP-1) receptors is effective in reducing body weight and fat mass, but its cardiovascular (CV) effects are unknown. Aims: The primary objective of the SYNCHRONIZE-CV outcomes trial (CVOT) is to test non-inferiority of survodutide compared with placebo for time-to-first occurrence of any of the adjudicated components of the primary composite endpoint of 5-point major adverse CV events, defined as CV death, non-fatal stroke, non-fatal myocardial infarction, ischemia-related coronary revascularization, or heart failure events. Methods: We describe the baseline characteristics of participants in the SYNCHRONIZE-CVOT, a phase 3, randomized, double-blind, parallel-group, event-driven, CV safety study of survodutide, a dual glucagon and GLP-1 receptor agonist, compared with placebo in adults with a body mass index ≥27 kg/m 2 and established CV or chronic kidney disease (CKD), and/or at least 2 obesity-related complications or risk factors for CV disease (CVD). Participants were randomized 1:1:1 to once-weekly subcutaneous injections of survodutide (up-titrated to 3.6 or 6.0 mg) or placebo, in addition to standard lifestyle-based care. Results: Overall, 5,508 participants were randomized to and treated with survodutide or placebo across 524 sites in 34 countries (mean age 61 years, 40% women, mean body mass index 37 kg/m 2 , mean estimated glomerular filtration rate 77 mL/min/1.73m 2 ; Table ). At baseline, common CV risk factors included hypertension (88%), dyslipidemia (82%) and type 2 diabetes (53%). Established CVD included coronary artery disease (53%), prior myocardial infarction (35%), prior stroke (16%) and heart failure (11%); and 17% of participants had CKD. SYNCHRONIZE-CVOT enrolled a pre-specified subgroup of individuals with prevalent heart failure. Among these 601 participants with heart failure (NYHA II-III at screening), median NT-proBNP was 424 pg/ml and mean Kansas City Cardiomyopathy Questionnaire Total Symptom Score was 71. At baseline, more than half of participants with heart failure were treated with SGLT2 inhibitors and 66% with loop diuretics. Conclusions: SYNCHRONIZE-CVOT enrolled people who were overweight or obese across a broad spectrum of CVD and CKD risk categories. SYNCHRONIZE-CVOT is the first randomized, placebo-controlled, phase 3 trial that will determine the CV safety of survodutide in people with overweight/obesity and increased CV risk.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".