Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity (OASIS 4)

  • End date
    May 14, 2024
  • participants needed
  • sponsor
    Novo Nordisk A/S
Updated on 27 October 2022
body mass index


This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Condition Overweight, Obesity
Treatment semaglutide, Placebo semaglutide
Clinical Study IdentifierNCT05564117
SponsorNovo Nordisk A/S
Last Modified on27 October 2022


Yes No Not Sure

Inclusion Criteria

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) of
Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
Greater than or equal to 30.0 kg/m^2
History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria

A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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