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Clinical Trials/2025-524626-18-00
2025-524626-18-00RecruitingPhase 3

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

Novo Nordisk A/S100 sites in 9 countries315 target enrollmentStarted: August 11, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
315
Locations
100
Primary Endpoint
Relative change in body weight
Study OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To demonstrate the superiority of oral semaglutide 00 mg and/or 00 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity on weight loss in adults with overweight or obesity.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

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 a) ≥ 27.0 kg/m2 with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease OR b) ≥ 30.0 kg/m2
  • •History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria

  • •A self-reported change in body weight > 5 % within 90 days before screening irrespective of medical records
  • •HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
  • •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, OR any consistent use of 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 00 before screening. Consistent use is defined as treatment 00.

Arms & Interventions

Placebo for semaglutide D tablet

Placebo

Intervention: Placebo for semaglutide D tablet (Drug)

Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets

Test

Intervention: Rybelsus 1.5 mg tablets (Drug)

Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets

Test

Intervention: Rybelsus 9 mg tablets (Drug)

Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets

Test

Intervention: Rybelsus 4 mg tablets (Drug)

Outcomes

Primary Outcomes

Relative change in body weight

Relative change in body weight

Secondary Outcomes

  • CCI
  • Achievement of body weight reduction ≥ 5% (Yes/No)
  • Achievement of body weight reduction ≥ 10% (Yes/No)
  • Achievement of body weight reduction ≥ 15% (Yes/No)
  • Change in waist circumference
  • Change in body weight
  • Change in hsCRP
  • Change in Glycaemic status
  • Change in lipids: Total cholesterol HDL cholesterol Non-HDL cholesterol LDL cholesterol VLDL cholesterol Triglycerides Free fatty acids
  • Change in systolic blood pressure
  • Change in diastolic blood pressure
  • Change in FPG
  • Change in HbA1c
  • Change in waist-height ratio (WtHR)
  • Number of treatment emergent adverse events
  • Number of treatment emergent serious adverse events
  • Number of treatment emergent adverse events leading to permanent treatment discontinuation

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

EU Submission Hub

Scientific

Novo Nordisk A/S

Study Sites (100)

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