Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
Recruiting
Phase 3Interventional Study
OverweightObesity
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
450 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for
This trial is looking for adults with excess body weight who want to lose weight. Participants will take oral semaglutide or a placebo to see how effective it is for weight loss.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a BMI of 27 or higher with weight-related health issues, or a BMI of 30 or higher.
I have tried to lose weight before but was unsuccessful.
I have given informed consent to participate in the study.
You may not be able to join if
I have lost more than 5% of my body weight in the last 90 days.
My HbA1c level is 6.5% or higher.
I have used GLP-1 receptor agonists or similar treatments regularly before the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
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 ti…
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.
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