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PIONEER 1 (Aroda et al., Diabetes Care 2019): 703 patients with type 2 diabetes Oral semaglutide 3 mg, 7 mg, or 14 mg once daily vs placebo 26-week trial Primary outcome: HbA1c reduction Results at 26 weeks: 14 mg daily: -1.2% HbA1c reduction, -3.7 kg weight loss 7 mg daily: -0.9% HbA1c reduction, -2.3 kg weight loss 3 mg daily: -0.6% HbA1c reduction, -1.5 kg weight loss Placebo: -0.2% HbA1c reduction, -1.4 kg weight loss The trial tested daily dosing exclusively

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Zepbound is indicated for adults with obesity (with a BMI of 30 kg/m2 or greater), or those who are overweight (with a BMI of 27 kg/m2 or greater) and also have weight-related medical problems such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease, to lose weight and keep it off

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It's important to note that cardiovascular risk reduction is not a class-wide effect

Both MDLs will be overseen by Judge Karen S