Study S001472

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05035095
Acronym: OASIS 1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 667
Start: 2021-09-13
Primary completion: 2023-03-24
Lead sponsor: Novo Nordisk A/S
Conditions: Obesity; Overweight
Interventions: DRUG:Oral semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1253-1670; EUDRACT_NUMBER:2020-002953-11

Registered primary outcomes

Percentage Change in Body Weight [Baseline (week 0), end-of-treatment (week 68)]
Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No) [At end-of-treatment (week 68)]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0029025	Impact of weight on daily activities questionnaire in patients with overweight or obesity: Psychometric evaluation using data from the OASIS 1 trial. von Huth Smith L, Clinical obesity	2025	Other trial	PMID 40452267 DOI	cites ClinicalTrials.gov:NCT05035095
R0016435	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, Lancet (London, England)	2023	Randomized trial	PMID 37385278 DOI	cites ClinicalTrials.gov:NCT05035095; registry reference BACKGROUND:37385278