Evidence map›Paper›PMID 37385278›Full record

Trial reportLancet (London, England)2023

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.

Filip K Knop, Vanita R Aroda, Ruben D do Vale, Thomas Holst-Hansen, Peter N Laursen, Julio Rosenstock, Domenica M Rubino, W Timothy Garvey, OASIS 1 Investigators

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05035095. Cited by 206 papers, 22 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
206citing papers in PubMed, 22 pooled it
82.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05035095 phase3completed

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

Ran2021Enrolled667Registered outcomes29Posted comparisons4ConditionsObesity, OverweightArmsOral semaglutide, Placebo (semaglutide)
Open the trial in the graph
3 · Its place in the literature

Who cites it

206 citing papers in PubMed, 22 syntheses or guidelines pooled it, 343 citations in OpenAlex.

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146 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 2 countries.

Filip K KnopCenter for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Herlev, Denmark. Electronic address: filip.krag.knop.01@regionh.dk.
Vanita R ArodaDivision of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Ruben D do ValeNovo Nordisk, Søborg, Denmark.
Thomas Holst-HansenNovo Nordisk, Søborg, Denmark.
Peter N LaursenNovo Nordisk, Søborg, Denmark.
Julio RosenstockVelocity Clinical Research at Medical City, Dallas, TX, USA.
Domenica M RubinoWashington Center for Weight Management and Research, Arlington, VA, USA.
W Timothy GarveyDepartment of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.
OASIS 1 Investigators
Novo Nordisk (Denmark) · DKBrigham and Women's Hospital · USUniversity of Alabama at Birmingham · USUniversity of Copenhagen · DKVelocity Clinical Research (United States) · USWashington Center for Weight Management and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe assessed the efficacy and safety of the oral glucagon-like peptide-1 analogue, semaglutide 50 mg, taken once per day versus placebo for the treatment of overweight or obesity in adults without type 2 diabetes.

methodsThis randomised, double-blind, placebo-controlled, phase 3, superiority trial enrolled adults with a BMI of at least 30 kg/m

findingsFrom Sept 13 to Nov 22, 2021, 709 participants were screened, of whom 667 were randomly assigned to oral semaglutide 50 mg (n=334) or placebo (n=333). The estimated mean bodyweight change from baseline to week 68 was -15·1% (SE 0·5) with oral semaglutide 50 mg versus -2·4% (0·5) with placebo (estimated treatment difference -12·7 percentage points, 95% CI -14·2 to -11·3; p<0·0001). More participants reached bodyweight reductions of at least 5% (269 [85%] of 317 vs 76 [26%] of 295; odds ratio [OR] 12·6, 95% CI 8·5 to 18·7; p<0·0001), 10% (220 [69%] vs 35 [12%]; OR 14·7, 9·6 to 22·6), 15% (170 [54%] vs 17 [6%]; OR 17·9, 10·4 to 30·7), and 20% (107 [34%] vs 8 [3%]; OR 18·5, 8·8 to 38·9) at week 68 with oral semaglutide 50 mg versus placebo. Adverse events were more frequent with oral semaglutide 50 mg (307 [92%] of 334) than with placebo (285 [86%] of 333). Gastrointestinal adverse events (mostly mild to moderate) were reported in 268 (80%) participants with oral semaglutide 50 mg and 154 (46%) with placebo.

interpretationIn adults with overweight or obesity without type 2 diabetes, oral semaglutide 50 mg once per day led to a superior and clinically meaningful decrease in bodyweight compared with placebo.

fundingNovo Nordisk.

Indexed as

ObesityAdministration, OralAdultBody WeightDouble-Blind MethodGlucagon-Like PeptidesHumansHypoglycemic AgentsOverweightSemaglutideTreatment OutcomeGlucagon-Like PeptidesHypoglycemic AgentsSemaglutide

Identifiers

PMID37385278
OpenAlexW4381953540

What OpenQuestion holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.