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Pivotal Phase 3 trials that supported FDA approval, plus head-to-head and cardiovascular outcomes studies. Patient counts, endpoints, results, and citation links.
20% relative risk reduction in MACE (HR 0.80, 95% CI 0.72-0.90). First weight-loss drug with established CV benefit in non-diabetic population.
Mean weight loss 15.0% (5 mg), 19.5% (10 mg), and 20.9% (15 mg) vs 3.1% with placebo. 91.0% of patients on 15 mg lost ≥5%.
Mean weight loss 14.9% with semaglutide vs 2.4% with placebo. 86.4% of semaglutide patients lost ≥5% body weight vs 31.5% in placebo group.
A1C reduction 2.01-2.30% with tirzepatide vs 1.86% with semaglutide. Tirzepatide superior at all doses in head-to-head.
Non-inferior CV safety vs placebo (HR 0.79, 95% CI 0.57-1.11). 51% reduction in CV mortality (HR 0.49).
26% relative risk reduction in major adverse cardiovascular events (HR 0.74, 95% CI 0.58-0.95). Established CV benefit class label.
Mean weight loss 8.0% with liraglutide vs 2.6% with placebo. 63.2% lost ≥5% vs 27.1% placebo. First weight-loss GLP-1 to gain FDA approval.