Stomach and bowel side effects were most common. Altered skin sensation and stopping treatment due to side effects were also reported.
TRIUMPH-1: results, safety and sources
At 80 weeks, peer-reviewed treatment-regimen/ITT mean weight change: −17.6% (4 mg), −23.7% (9 mg), −25.0% (12 mg) versus −3.9% placebo. Earlier Lilly efficacy-estimand headline: −28.3% (12 mg) versus −2.2% placebo at 80 weeks (70.3 lbs mean loss); 45.3% achieved ≥30% weight loss in that efficacy analysis. Lilly reported 30.3% mean loss at 104 weeks only in the selected baseline BMI ≥35 completers who tolerated treatment and continued on 12 mg in the prespecified extension.
Safety: Gastrointestinal adverse events were most common. Lilly’s June release reported dysesthesia (altered skin sensation) in 12.5% with 12 mg versus 0.9% placebo, and adverse-event discontinuation in 11.3% versus 4.9%, respectively.
NEJM TRIUMPH-1 publicationLilly TRIUMPH-1 80-week efficacy estimandLilly TRIUMPH-1 efficacy estimand and safety









