Once-weekly survodutide reduced body weight significantly more than placebo in adults with obesity without diabetes. At week 76, the mean change in body weight was -12.2% with the 3.6-mg dose, -13.0% with the 6.0-mg dose, and -5.4% with placebo. Gastrointestinal symptoms were the most common adverse events, and no deaths were reported.
Late-phase clinical trial — Randomized, double-blind, multicenter, phase 3 trial. Population: Adults with obesity (BMI ≥30, or ≥27 with an obesity-related complication), without diabetes. Sample size: 725 participants. Follow-up: 76 weeks. Interventions: Survodutide once weekly subcutaneously, dose adjusted up to 3.6 mg; Survodutide once weekly subcutaneously, dose adjusted up to 6.0 mg. Cited by 3 other papers.
Among 725 participants (mean age 47.1 years; 40.6% men; baseline mean BMI 37.9; baseline mean body weight 108.8 kg), the mean change in body weight at week 76 was -12.2% (95% CI, -13.6 to -10.8) in the 3.6-mg group, -13.0% (95% CI, -14.4 to -11.6) in the 6.0-mg group, and -5.4% (95% CI, -6.9 to -4.0) in the placebo group. A weight reduction of at least 5% was achieved by 72.6%, 71.9%, and 46.3% of participants, respectively (P<0.001 for all comparisons with placebo). Gastrointestinal symptoms were the most common adverse events (80.9%, 89.7%, and 47.9% in the three groups) and were typically mild to moderate. No deaths were reported.
For researchers studying survodutide, this paper provides randomized, double-blind, phase 3 evidence on the drug's effect on body weight in a large population of adults with obesity without diabetes. It also describes the incidence of gastrointestinal symptoms at two dose levels compared with placebo. It does not establish cardiovascular outcomes, effects in people with diabetes, or safety and durability of weight loss beyond the 76-week trial.
Peptide profiles: Survodutide.
All indexed evidence: Survodutide trials & papers.
Related studies: Dual Glucagon and GLP-1 Receptor Agonist Survodutide Improves Biomarkers of Beta-Cell…, Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver…, Author Correction: Survodutide in adults with obesity and metabolic…, Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline….