Design
Phase 3, double-blind randomized controlled trial
Evidence chain
Population
2,539 adults with obesity, or overweight with a weight-related complication, without diabetes.
Intervention and comparator
Three tirzepatide groups versus placebo for 72 weeks, including an escalation period.
Endpoint
Percentage change in body weight and categorical weight-loss thresholds.
Reported result
Mean weight change was −15.0%, −19.5%, and −20.9% across tirzepatide groups and −3.1% with placebo.
Leptox interpretation
Substantial average efficacy under trial conditions, with gastrointestinal adverse events and treatment discontinuation relevant to the balance of benefits and risks.