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doi: 10.1016/j.japh.2023.06.003

Study Population : 2,539 adults without diabetes Average age: 44.9 years Average baseline BMI: 38.0 Average baseline weight: 231.1 pounds 67.5% female 70.1% White, 22.3% Hispanic/Latino, 5.4% Black, 2.2% Other Interventions : Tirzepatide 5 mg once weekly (n=630) Tirzepatide 10 mg once weekly (n=636) Tirzepatide 15 mg once weekly (n=630) Placebo once weekly (n=643) All groups: Counseling for 500-calorie deficit and 150 minutes/week physical activity Duration : 72 weeks Primary Outcome - Mean Percentage Weight Loss : Tirzepatide 5 mg: -15.0% (95% CI: -15.9 to -14.2) Tirzepatide 10 mg: -19.5% (95% CI: -20.4 to -18.5) Tirzepatide 15 mg: -20.9% (95% CI: -21.8 to -19.9) Placebo: -3.1% (95% CI: -4.3 to -1.9) Secondary Outcomes - Categorical Weight Loss (15 mg dose): 5% weight loss : 96.0% tirzepatide vs 34.3% placebo 10% weight loss : 89.4% tirzepatide vs 16.6% placebo 15% weight loss : 78.9% tirzepatide vs 8.2% placebo 20% weight loss : 62.7% tirzepatide vs 1.3% placebo 25% weight loss : 42.4% tirzepatide vs 0.3% placebo Trial Completion Rates : Tirzepatide 5 mg: 84.8% Tirzepatide 10 mg: 85.2% Tirzepatide 15 mg: 83.7% Placebo: 91.4% Safety Data (15 mg dose): Gastrointestinal adverse events: 81.0% tirzepatide vs 63.8% placebo Serious adverse events: 6.2% tirzepatide vs 4.2% placebo Discontinuation due to adverse events: 6.2% tirzepatide vs 2.2% placebo Real-World Evidence: Beyond Clinical Trials While randomized controlled trials provide the highest quality efficacy and safety data, real-world evidence studies examine outcomes in routine clinical practice settings without strict trial protocols

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Additionally, heterogeneity in study design and individual patient differences may have influenced the reported incidence rates, underscoring the need for further investigation into the evaluation of gastrointestinal adverse events in different patient populations