OB2025 Obesity Update 2025 Poster Presentations (10 abstracts)
Efficacy and safety of semaglutide 7.2 mg in obesity: STEP UP trial
Iskandar Idris 1,2 , Sean Wharton 3,4 , Paula Freitas 5,6 , Jøran Hjelmesaeth 7,8 , Maria Kabisch 9 , Kristian Kandler 10 , Ildiko Lingvay 11 , Maria De Los Angeles Quiroga Pelaez 9 , Julio Rosenstock 12 & W. Timothy Garvey 13
1University of Nottingham, Derby, United Kingdom; 2University Hospitals of Derby and Burton Foundation Trust, Derby, United Kingdom; 3University of Toronto, Burlington, ON, Canada; 4Wharton Medical Clinic Weight and Diabetes Management, Burlington, ON, Canada; 5University of Porto, Porto, Portugal; 6São João Local Health Unit (ULS), Porto, Portugal; 7Vestfold Hospital Trust, Tønsberg, Norway; 8University of Oslo, Oslo, Norway; 9Novo Nordisk, København, Denmark; 10Novo Nordisk, Søborg, Denmark; 11University of Texas Southwestern Medical Center, Dallas, TX, United States; 12Velocity Clinical Research, Dallas, TX, United States; 13University of Alabama at Birmingham, Mountain Brook, AL, United States
Introduction and Objective: This multicentre, double-blind trial (NCT05646706) assessed the efficacy and safety of semaglutide 7.2 mg in adults with obesity (BMI ≥30 kg/m2) without type 2 diabetes.
Methods: Participants were randomised 5:1:1 to once-weekly s.c. semaglutide 7.2 mg, 2.4 mg or placebo plus lifestyle intervention for 72 weeks, with 9-week off-treatment follow-up. Co-primary endpoints were percentage weight loss (%WL) and proportion reaching ≥5% WL with semaglutide 7.2 mg vs placebo. Confirmatory endpoints were %WL with 7.2 mg vs 2.4 mg, waist circumference (WC) change and proportion reaching ≥10%, ≥15%, ≥20% and ≥25% WL thresholds vs placebo and ≥20% and ≥25% vs 2.4 mg. Safety was assessed. Results for all endpoints were from baseline to week 72 for the treatment policy estimand (in-trial observation period).
Results: Participants (7.2 mg [n =1005], 2.4 mg [n =201], placebo [n =201]) had a mean age of 47 years, weight 113 kg, BMI 39.9 kg/m2, WC 119 cm and 74% were female. Most treatment completers reached the maximum semaglutide dose (7.2 mg, 75.4%; 2.4 mg, 89.3%; placebo, 96.5%) at week 72. Mean %WL was greater with 7.2 mg (18.7%) vs 2.4 mg (15.6%) or placebo (3.9%), with estimated treatment differences (ETDs; 95% confidence interval [CI]) of –3.1% (–4.7, –1.6) for 7.2 mg vs 2.4 mg, and –14.8% (–16.2, –13.4) for 7.2 mg vs placebo (P <0.001 for both). WC was reduced with 7.2 mg vs placebo (P <0.001). Proportion of participants achieving WL thresholds at week 72 for 7.2 mg, 2.4 mg and placebo, respectively, were: 90.7, 89.9 and 36.8% for ≥5%; 82.4, 75.1 and 20.5% for ≥10%; 66.5, 54.5 and 7.6% for ≥15%; 47.7, 33.3 and 2.9% for ≥20%; and 31.2, 15.3 and 0% for ≥25%. Gastrointestinal adverse events (AEs) were reported by 70.8%, 61.2% and 42.8% of participants with 7.2 mg, 2.4 mg and placebo, respectively; 3.3%, 2.0% and none discontinued due to these AEs; serious AEs were reported by 6.8%, 10.9% and 5.5% of participants, respectively.
Conclusion: Semaglutide 7.2 mg was superior to 2.4 mg and placebo for percentage weight loss in adults with obesity, with a similar safety profile to 2.4 mg.
Volume 5
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