Obesity, Overweight
Conditions
Brief 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.
Interventions
DRUGSemaglutide
Participants will receive semaglutide orally.
DRUGPlacebo
Participants will receive placebo orally.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to week 60 | Measured as percentage change in body weight. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No) | At week 60 | Measured as count of participant. |
| Achievement of body weight reduction ≥ 10% (Yes/No) | At week 60 | Measured as count of participant. |
| Achievement of body weight reduction ≥ 15% (Yes/No) | At week 60 | Measured as count of participant. |
| Change in waist circumference | From baseline (week 0) to week 60 | Measured as centimeter (cm). |
| Change in body weight | From baseline (week 0) to week 60 | Measured as kilogram (kg). |
| Change in high sensitivity C-Reactive Protein (hsCRP) | From baseline (week 0) to week 60 | Measured as milligrams per deciliter (mg/dL). |
| Change in systolic blood pressure | From baseline (week 0) to week 60 | Measured as millimetres of mercury (mmHg). |
| Change in diastolic blood pressure | From baseline (week 0) to week 60 | Measured as (mmHg). |
| Change in fasting plasma glucose (FPG) | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in glycated haemoglobin (HbA1c) | From baseline (week 0) to week 60 | Measured as %-point. |
| Change in glycaemic status | From baseline (week 0) to week 60 | Measured as count of participants. |
| Change in lipids: Total cholesterol | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: High density lipoprotein (HDL) cholesterol | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: Non-HDL cholesterol | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: Low density lipoprotein (LDL) cholesterol | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: Very low density lipoprotein (VLDL) cholesterol | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: Triglycerides | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in lipids: Free fatty acids | From baseline (week 0) to week 60 | Measured as ratio to baseline. |
| Change in waist-height ratio (WtHR) | From baseline (week 0) to week 60 | Measured as change in waist-height ratio. |
| Number of treatment emergent adverse events | From baseline (week 0) to week 67 | Measured as count of events. |
| Number of treatment emergent serious adverse events | From baseline (week 0) to week 67 | Measured as count of events. |
| Number of treatment emergent adverse events leading to permanent treatment discontinuation | From baseline (week 0) to week 67 | Measured as count of events. |
Countries
Belgium, Bulgaria, Denmark, France, Greece, Netherlands, Poland, Spain, Sweden, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed