Obesity, Overweight
Conditions
Brief summary
This study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year.Participants will have 14 clinic visits and 7 phone calls with the study doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.
Interventions
DRUGOral semaglutide
Participants will receive a daily dose of oral semaglutide.
DRUGPlacebo (semaglutide)
Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female, age greater than or equal to 18 years at the time of signing informed consent * Body mass index (BMI): greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m\^2 * History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
* HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening * A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Body Weight | Baseline (week 0), end-of-treatment (week 68) | Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No) | At end-of-treatment (week 68) | Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No) | At end-of-treatment (week 68) | Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented. |
| Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No) | At end-of-treatment (week 68) | Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented. |
| Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No) | At end-of-treatment (week 68) | Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented. |
| Change in Waist Circumference | Baseline (week 0), end-of-treatment (week 68) | Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Body Mass Index (BMI) | Baseline (week 0), end-of-treatment (week 68) | Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function | Baseline (week 0), end-of-treatment (week 68) | The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. |
| Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain | Baseline (week 0), end-of-treatment (week 68) | Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline. |
| Change in Systolic Blood Pressure | Baseline (week 0), end-of-treatment (week 68) | Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Diastolic Blood Pressure | Baseline (week 0), end-of-treatment (week 68) | Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Glycosylated Haemoglobin (HbA1c) | Baseline (week 0), end-of-treatment (week 68) | Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Fasting Plasma Glucose (FPG) | Baseline (week 0), end-of-treatment (week 68) | Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline. |
| Change in Total Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Triglycerides (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in Free Fatty Acids (mg/dL) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | Baseline (week 0), end-of-treatment (week 68) | Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Number of Treatment Emergent Adverse Events | From baseline (week 0) to end-of-study (week 75) | Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product. |
| Number of Serious Adverse Events | From baseline (week 0) to end-of-study (week 75) | Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event. |
| Change in Body Weight - Kilogram (Kg) | Baseline (week 0), end-of-treatment (week 68) | Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented. |
| Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no) | At end-of-treatment (week 68) | Number of participants who's body mass index (BMI) greater than or equal (≥) 30 at baseline and BMI lesser than (\<) 30 at week 68 (yes/no) from (week 0) to end-of-treatment (week 68) is presented. |
| Change in Pulse | Baseline (week 0), end-of-treatment (week 68) | Change in pulse from baseline (week 0) to end-of-study (week 68) is presented. |
| Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes) | Baseline (week 0), end-of-treatment (week 68) | Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and end-of-treatment (week 68) are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) less than (\<) 5.7%; 2) Pre-diabetes: HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: HbA1c greater than or equal to (\>=) 6.5%. |
| Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No) | At end-of-treatment (week 68) | The IWQOL-Lite-CT (measured as score on a scale) is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life. |
| Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No) | From baseline (week 0) to end-of-treatment (week 68) | Number of participants with change in SF-36 v2.0 physical functioning score ≥ 3.7 (yes/no) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). A positive change score indicates an improvement since baseline. The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. |
Countries
Canada, Denmark, Finland, France, Germany, Japan, Poland, Russia, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 1452)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 50 sites in 9 countries as follows: Canada (5 sites), Denmark (3 sites), Finland (3 sites), France (5 sites), Germany (7 sites), Japan (3 sites), Poland (5 sites), Russia (8 sites) and United States (11 sites).
Pre-assignment details
The trial included an initial 16-week dose-escalation period and a 52-week dose maintenance period. Participants were randomized in 1:1 ratio either to receive oral semaglutide 50 mg or placebo. The treatment is an adjunct to reduced-calorie diet and increased physical activity.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 296 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race/Ethnicity, Customized Asian | 36 Participants |
| Race/Ethnicity, Customized Black or African American | 21 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 23 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 246 Participants |
| Sex: Female, Male Female | 238 Participants |
| Sex: Female, Male Male | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 334 | 0 / 333 |
| other Total, other adverse events | 292 / 334 | 242 / 333 |
| serious Total, serious adverse events | 32 / 334 | 29 / 333 |
Outcome results
None listed