- Design
- Phase 3, multinational, randomised, double-blind, placebo-controlled
- Population
- 752 adults with type 2 diabetes and BMI 27 or more
- Primary outcome
- Percent change in body weight, and weight reduction of at least 5%, at week 76
- Effect
- -8.2% (3.6 mg) and -9.8% (6.0 mg) vs -3.9% with placebo; at least 5% loss in 57.6%, 64.5% vs 35.1%
SYNCHRONIZE-2 was a multinational, double-blind, phase 3 trial in 752 adults with type 2 diabetes and a BMI of 27 or more. Mean age was 55.7 years, mean BMI 36.5, and mean baseline HbA1c 7.4%. They received once-weekly survodutide 3.6 mg, 6.0 mg or placebo for 76 weeks.
Under the treatment-regimen estimand, weight fell 8.2% (95% CI -9.2 to -7.2) on 3.6 mg, 9.8% (-10.8 to -8.8) on 6.0 mg and 3.9% (-4.9 to -2.9) on placebo. Weight loss of at least 5% occurred in 57.6%, 64.5% and 35.1%. HbA1c fell by 0.9, 0.8 and 0.2 percentage points.
Gastrointestinal adverse events were most common: 72.8%, 77.7% and 38.6% respectively, generally mild to moderate and transient.
Survodutide is investigational. The result tells you where a glucagon/GLP-1 dual agonist may sit in future, not what to prescribe now.
- Survodutide is investigational and not available for prescribing; the data inform counselling, not current practice.
- Placebo arms lost 3.9% of body weight, which is a reminder of what lifestyle support alone achieved in the trial.
- Expect gastrointestinal effects to be the main tolerability question with this class.
- HbA1c fell 0.8 to 0.9 points from a baseline of 7.4%, a modest glycaemic effect next to the weight effect.
Why it matters
Weight is increasingly the lever for type 2 diabetes control, and this adds another mechanism to the field.
Don't overread it
The trial reports weight and HbA1c, not cardiovascular or kidney outcomes, and was sponsor-funded.
The statistics, in plain English
The confidence intervals for each survodutide dose sit entirely beyond the placebo interval, which fits the P<0.001 reported. The treatment-regimen estimand counts everyone as randomised, whatever they did afterwards, so it tends to give a more conservative estimate than an on-treatment analysis.
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