Health Trials

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

ConditionsOverweightObesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide

    Drug

    Participants will receive semaglutide orally.

  • Placebo

    Drug

    Participants will receive placebo orally.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage change in body weight.

Time frame
From baseline (week 0) to week 60

Secondary outcomes

1

Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)

Measured as count of participant.

Time frame
At week 60
2

Achievement of body weight reduction ≥ 10% (Yes/No)

Measured as count of participant.

Time frame
At week 60
3

Achievement of body weight reduction ≥ 15% (Yes/No)

Measured as count of participant.

Time frame
At week 60
4

Change in waist circumference

Measured as centimeter (cm).

Time frame
From baseline (week 0) to week 60

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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