Major trials

IWQOL-Lite-CT

The Phase 3 trials that won approval, and the outcome studies that came afterward on cardiovascular, kidney and sleep-apnea endpoints.

Definition

Impact of Weight on Quality of Life, Lite Clinical Trials version — a 20-item patient-reported questionnaire validated for obesity drug trials, scored 0–100 with physical-function and psychosocial subdomains reported separately. Around 14.6 points is the meaningful-improvement threshold. STEP-1 and SURMOUNT-1 both posted large gains, which FDA used in weighing quality-of-life claims for Wegovy and Zepbound labeling.

STEP-1 quality-of-life endpoint

GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature. Not one of them is an AI-generated summary.

Other terms under Major trials

Where the evidence lives