Synopsis of the original article

Oral semaglutide 50 mg taken once

per day in adults with overweight or
obesity (OASIS 1): a randomised,
double-blind, placebo-controlled,
phase-3 trial
Knop FK, et al. Lancet 2023. DOI: 10.1016/S0140-
6736(23)01185-6
Synopsis created and reviewed by Novo Nordisk

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Introduction

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The efficacy and safety of once-daily oral semaglutide
50 mg
50 mg, a GLP-1 analogue, were assessed vs placebo for
the treatment of overweight or obesity in adults without
type 2 diabetes

GLP-1, glucagon-like peptide-1. © 2023 Novo Nordisk A/S

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OASIS 1 trial design

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Oral semaglutide escalated
Trial design Adults with BMI to 50 mg once daily
≥30 kg/m2 (or ≥27 kg/m2 N=667 + lifestyle intervention
Double-blind, with ≥1 weight-related
randomised, controlled, complication/ R
phase 3 superiority trial comorbidity)
1:1 Placebo once daily
of once-daily oral
+ lifestyle intervention
semaglutide 50 mg vs
placebo, plus lifestyle No history of diabetes
0 68-week 68
intervention treatment period

Coprimary endpoints Confirmatory secondary endpoints

Percentage change in body weight at week 68 Achievement of ≥10%, ≥15% and ≥20%
Achievement of ≥5% body weight loss at week 68 body weight loss at week 68

BMI, body mass index. © 2023 Novo Nordisk A/S

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Oral semaglutide 50 mg led to superior and clinically
meaningful weight loss vs placebo

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Change in body weight Proportions of participants Safety
from baseline to week 68 achieving ≥5%, ≥10%, ≥15% and
≥20% body weight loss at week 68
Oral semaglutide
Adverse events
0
50 mg Placebo ≥5% ≥10%
More frequent with
–-2 oral semaglutide 50 mg
Change in body weight (%)

12%
–-4 –2.4% 85% 69% vs placebo:
p<0.0001*
26% 92% vs 86%
–-6
..0
–-8
–-10
≥15% ≥20% Gastrointestinal
6% 3% adverse events
–-12
80% with oral
–-14 54% 34% semaglutide 50 mg
–-16 –15.1% 46% with placebo
ETD –12.7 %-points Mostly mild-to-moderate
[95% CI –14.2, –11.3]; p<0.0001 Oral semaglutide 50 mg Placebo in severity
(% participants) (% participants)

*P value is based on the odds ratio and is only provided for the coprimary endpoint. CI, confidence interval; ETD, estimated treatment difference. © 2023 Novo Nordisk A/S
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Conclusions

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In adults with overweight or obesity,
without type 2 diabetes, once-daily oral
50 mg semaglutide 50 mg achieved a superior
and clinically meaningful decrease in
body weight compared with placebo

© 2023 Novo Nordisk A/S

Further reproduction and distribution is permitted