In patients with obesity but without diabetes, treatment with survodutide results in substantial reductions in body weight compared with placebo, according to the phase III SYNCHRONIZE-1 trial.
SYNCHRONIZE-1 included 725 adult participants (mean age was 47.1 years, 40.6 percent male) with a BMI of ≥30 or ≥27 kg/m2 plus at least one obesity-related complication (excluding diabetes). These participants were randomly assigned to receive survodutide administered subcutaneously once weekly at a dose adjusted up to 3.6 mg (n=241) or 6 mg (n=242) or placebo (n=242), in addition to counselling for lifestyle modification.
The two primary endpoints were the percent change in body weight and a reduction in body weight of ≥5 percent from baseline to week 76.
At baseline, the mean BMI overall was 37.9 kg/m2, and the mean body weight was 108.8 kg. Over 76 weeks of treatment, mean body weight decreased by 12.2 percent with survodutide 3.6 mg, by 13 percent with survodutide 6 mg, and by 5.4 percent with placebo. The corresponding percentages of participants who lost at least 5 percent of their body weight were 72.6 percent, 71.9 percent, and 46.3 percent (p<0.001 for all).
As for safety, the most common adverse events were gastrointestinal symptoms, occurring in 80.9 percent of the participants in the 3.6-mg group, 89.7 percent of those in the 6-mg group, and 47.9 percent of those in the placebo group. Most of these events were mild to moderate in severity. There were no deaths reported during the trial.