Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
Purpose
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.
Conditions
- Overweight
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- 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 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Semaglutide |
Participants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity. |
|
|
Placebo Comparator Placebo |
Participants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity. |
|
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S