Novo Nordisk A/s Class B · OMXCOP:NOVO_B
Novo Nordisk A/s Class B — Technical Presentation (September 2024)
13 slides from Novo Nordisk A/s Class B's technical presentation, Sep 5, 2024
Slide 1: Once-weekly semaglutide 2.4 mg for weight management in an Asian population with obesity: STEP 11
Once-weekly semaglutide 2.4 mg for weight management in an Asian population with obesity diagnosed as BMI ≥25 kg/m2, according to WHO guidelines: Results from the STEP 11 trial Soo Lim1*, Supawan Buranapin2, Xiaolei Bao3, María Quiroga4, Kyung Hee Park5, Jee-Hyun Kang6, Anders Rasmussen Rinnov4, Ari
Slide 2: Conflicts of interest
Conflicts of interest • Soo Lim has received a research grant from Merck Sharp & Dohme, Novo Nordisk and LG Chem, and honoraria as a consultant or speaker for AstraZeneca, Boehringer Ingelheim, Abbott, LG Chem, Daewoong Pharmaceutical, Chong Kun Dang Pharmaceutical and Novo Nordisk Lim S, et al. Pre
Slide 3: Introduction
Scan QR code or visit the website below for: further details of the STEP clinical trial programme Introduction https://sciencehub.novonordisk.com/ Asian populations accumulate higher visceral adiposity than White populations at an equivalent BMI, and are at risk of developing obesity-related comorbi
Slide 4: STEP 11 trial design
STEP 11 trial design Double-blind, randomised, placebo-controlled trial in South Korea and Thailand Key inclusion criteria Randomisation (2:1) • Male or female N=150 • Age ≥18 years Once-weekly s.c. semaglutide 2.4 mg • BMI ≥25 kg/m2 • Both parents of Asian descent • History of ≥1 self-reported Once
Slide 5: Participant disposition
Participant disposition Screened N=160 Screening failures: n=8 Withdrawn before randomisation: n=2 Randomised (FAS) n=150 Exposed (SAS) FAS n=150 • Includes all randomised participants • Contributes to the evaluation as randomised • Used for the analysis of efficacy Semaglutide 2.4 mg Placebo endpoi
Slide 6: Demographics and baseline characteristics
Demographics and baseline characteristics Male/female Mean age Asian 26.0%/74.0% 39 years 100% Mean body Mean Mean waist weight circumference Mean HbA1c BMI 83.8 kg 31.3 kg/m2 98.1 cm 38 mmol/mol (5.6%) %, proportion of participants of full analysis set; BMI, body mass index; HbA1c, glycated haemogl
Slide 7: Comorbidities at screening
Comorbidities at screening Obstructive sleep Cardiovascular Knee Dyslipidaemia Hypertension apnoea syndrome disease osteoarthritis 26.0% 22.7% 5.3% 2.0% 1.3% Proportion of participants with none to five or more comorbidities* at screening 0 1 2 3 4 ≥5 57.3% 24.0% 12.7% 3.3% 2.0% 0.7% *Comorbidities
Slide 8: Change in body weight (%)
Change in body weight (%) Primary endpoint Observed mean change over time Estimated mean change Mean baseline body weight: 83.8 kg from baseline to week 44* 0 0 –2 -2 Body weight change (%) –4 -4 -3.1 Body weight change (%) –6 –8 -6 –10 -8 –12 -10 –14 -12 –16 –18 -14 0 4 8 12 16 20 24 28 32 36 40 44
Slide 9: Categorical body weight loss
Categorical body weight loss Primary and secondary endpoints Observed proportions of participants with body OR 88.9 weight reductions at week 44 (95% CI 22.0, 359.6); p<0.0001 OR 30.6 100 96 (96.0) (95% CI 10.5, 89.3); p<0.0001 90 OR 25.1 Semaglutide 2.4 mg (95% CI 5.6, 111.6); 78 (78.0) Proportion
Slide 10: Change in cardiometabolic risk factors
Change in cardiometabolic risk factors Secondary endpoints Change in HbA1c Change in waist circumference (confirmatory endpoint) 5.7 0 5.6 Waist circumference (cm) -2 5.6 HbA1c (%) 5.5 -4 -3.0 Mean baseline HbA1c 5.6% -6 5.4 ETD (week 44): 5.3 –0.4 (95% CI –0.5, –0.3); -8 ETD (week 44): 5.2 p<0.0001
Slide 11: Change in lipids
Change in lipids Secondary endpoints Change in lipid profile ETR (95% CL) p value Geometric mean at baseline Favours Favours 0.0001 Semaglutide 2.4 mg / Placebo 0.91 (0.87, 0.96) 5.06 mmol/L (195.40 mg/dL) Semaglutide Placebo Favours Favours Semaglutide 2.4 mg / Placebo 0.96 (0.92, 1.01) 0.1359 1.40
Slide 12: Adverse events
Adverse events Overview and safety focus areas Semaglutide 2.4 mg Placebo Semaglutide 100 AEs within safety focus areas, Placebo 89.1 2.4 mg n (%) (n=49) (n=101) Proportion of participants (%) 80 77.6 GI AEs (OT) 69 (68.3) 22 (44.9) COVID-19 (OT) 16 (15.8) 16 (32.7) 60 Allergic reactions (OT) 9 (8.9
Slide 13: Conclusions
Conclusions Semaglutide 2.4 mg was superior to placebo with respect to percentage change in body weight (including ≥5%, ≥10% and ≥15% body weight responders) Improvements were also seen in change in body weight (kg), BMI, waist circumference, blood pressure, HbA1c, hsCRP and lipids with semaglutide
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