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Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight

RECRUITINGPhase 3Sponsored by Novo Nordisk A/S
Actively Recruiting
PhasePhase 3
SponsorNovo Nordisk A/S
Started2026-08-12
Est. completion2028-02-22
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations16 sites

Summary

The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.
* Female or male (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Body mass index (BMI) of

  1. ≥ 27.0 kilogram per square meter (kg/m\^2) with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease.

     OR
  2. ≥ 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% within 90 days before screening irrespective of medical records.
* HbA1c ≥ 6.5% (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening.
* Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.

Conditions3

ObesityOverweightWeight Loss

Interventions1

Locations16 sites

Uni of Alabama at Birmingham
Birmingham, Alabama, 35296
Headlands Research California, LLC
Escondido, California, 92025
National Research Institute - Huntington Park
Huntington Park, California, 90255
Los Angeles Institute for Metabolic Research
ERG Holding Company, LLC / Evolution Research Group, LLC
Delray Beach, Florida, 33445

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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