splitting doses of tirzepatide Dosing Safety: Why Dose Fails If you've been nervous about

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John Sharretts Diabetes, Lipid Disorders Obesity (Center for Drug Evaluation and Research) FDA serious conditions FDA tirzepatide (Zepbound) unmet medical need (Centers for Disease Control and Prevention CDC) 70% weight-related condition 1 Tirzepatide active ingredient Zepbound dual GLP-1/ GLP-1 receptor agonist receptors glucagon-like peptide-1 GLP-1 glucose-dependent insulinotropic polypeptide (GIP) (appetite) 2565 tirzepatide Mounjaro FDA reduced calorie diet increased physical activity 2 18 tirzepatide (Zepbound) FDA chronic weight management 2 phase 3 double-blind, randomized, controlled trial SURMOUNT-1 SURMOUNT-2 SURMOUNT-1 18 weight-related condition 1 2,539 4 tirzepatide (Zepbound) 5 mg, 10 mg 15 mg placebo 72 coprimary endpoints % 72 (baseline) 5% mean body weight 104.8 kg mean BMI was 38.0 94.5% BMI 30 30 SURMOUNT-1 New England Journal of Medicine (NEJM) 21 2565 mean percentage change 72 -15.0%, -19.5% -20.9% tirzepatide (Zepbound) 5 mg, 10 mg 15 mg -3.1% placebo % 5% 85%, 89% 91% tirzepatide (Zepbound) 5 mg, 10 mg 15 mg 35% placebo 50% 57% tirzepatide (Zepbound) 10 mg 15 mg 20% 20% 3% placebo SURMOUNT-1 tirzepatide (Zepbound) overall safety tolerability profiles incretin-based therapies FDA adverse events tirzepatide (Zepbound) 5 mg, 10 mg 15 mg placebo nausea, diarrhea, vomiting constipation adverse events severity mild to moderate SURMOUNT-2 18 weight-related condition 2 938 3 tirzepatide (Zepbound) 10 mg 15 mg placebo 72 co-primary objectives tirzepatide (Zepbound) 10 mg 15 mg placebo mean percentage change in body weight 72 percentage of participants 5% mean bodyweight 100.7 kg BMI 36.1 kg/m 2 HbA 1c 2-3 8.02% SURMOUNT-2 Lancet 19 2566 tirzepatide (Zepbound) 10 mg 15 mg -12.8% -14.7% 72 -3.2% placebo 7983% tirzepatide (Zepbound) 10 mg 15 mg 5% 32% placebo 39.7% 48.0% tirzepatide (Zepbound) 10 mg 15 mg 15% 72 2.7% placebo tirzepatide (Zepbound) 10 mg 15 mg placebo mean percentage change in body weight 72 percentage of participants 5% : www.fda.gov, www.drugs.com, www.nejm.org, www.medpagetoday.com, www2.diabetes.org

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TK, AT and EB designed the study

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Diarrhea or loose stool support Identify triggers such as high-fat foods, sugar alcohols, or large portions