Obesity, Overweight
Conditions
Brief summary
This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.
Interventions
DRUGSemaglutide
Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
DRUGPlacebo
Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.
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
* Age greater than or equal to 18 years at the time of signing informed consent. * Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m\^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m\^2, with or without weight related complications at screening. * History of at least one self-reported unsuccessful dietary effort to lose body weight. For participants with T2D at screening: \- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening Treated with either: * Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label. * Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening * Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol \[mmol/mol\]) as measured by the central laboratory at screening.
Exclusion criteria
* A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records. * Treatment with any medication for the indication of obesity within the past 90 days before screening. * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. For participants without T2D at screening: \- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory. For participants with T2D at screening: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight (%) | Baseline (week 0), end of treatment (week 44) | Percentage change in body weight from baseline (week 0) to end of treatment (week 44) is presented. |
| Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No) | At end of treatment (week 44) | Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No) | At end of treatment (week 44) | Number of participants who achieved ≥10% body weight reduction at the end of treatment (week 44) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction. |
| Change in Waist Circumference | Baseline (week 0), end of treatment (week 44) | Change in waist circumference from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Body Weight (kg) | Baseline (week 0), end of treatment (week 44) | Change in body weight in kilogram (kg) from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Body Mass Index | Baseline (week 0), end of treatment (week 44) | Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Waist-height Ratio (WtHR) | Baseline (week 0), end of treatment (week 44) | Change in waist-height ratio (WtHR) from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Systolic Blood Pressure | Baseline (week 0), end of treatment (week 44) | Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Diastolic Blood Pressure | Baseline (week 0), end of treatment (week 44) | Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented |
| Change in Total Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in total cholesterol measured in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in high density lipoprotein (HDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in low density lipoprotein (LDL) cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in VLDL cholesterol measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in Triglycerides (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in triglycerides measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in Free Fatty Acids (mmol/L) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in free fatty acids measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | Baseline (week 0), end of treatment (week 44) | Change in high sensitivity C-Reactive Protein (hsCRP) measured in milligram per litre (mg/L) from baseline (week 0) to end of treatment (week 44) is presented as ratio to baseline. |
| Change in HbA1c (%) | Baseline (week 0), end of treatment (week 44) | Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in HbA1c (mmol/Mol) | Baseline (week 0), end of treatment (week 44) | Change in HbA1c measured in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Fasting Plasma Glucose (mg/dL) | Baseline (week 0), end of treatment (week 44) | Change in fasting plasma glucose (FPG) measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) is presented. |
| Change in Fasting Plasma Glucose (mmol/L) | Baseline (week 0), end of treatment (week 44) | Change in FPG measured in mmol/L from baseline (week 0) to end of treatment (week 44) is presented. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study (week 49) | Number of TEAEs from baseline (week 0) to end of study (week 49) 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. |
| Number of Serious Adverse Events (SAEs) | From baseline (week 0) to end of study (week 49) | Number of SAEs from baseline (week 0) to end of study (week 49) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event. |
| Change in Pulse | Baseline (week 0), end of treatment (week 44) | Change in pulse from baseline (week 0) to end of treatment (week 44) is presented. |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D) | From baseline (week 0) to end of study (week 49) | Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L) confirmed by BG meter for participants with T2D from baseline (week 0) to end of study (week 49) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than 3.0 mmol/L (54 mg/dL) confirmed by BG meter. |
Countries
China, Taiwan
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Participant flow
Recruitment details
The trial was conducted at 19 sites across mainland China and Taiwan.
Pre-assignment details
Participants were randomised in 2:1 ratio to receive once weekly subcutaneous (s.c.) injection of either semaglutide 2.4 mg or semaglutide matching placebo as an adjunct to a reduced-calorie diet and increased physical activity. The trial has a 44-week treatment period (16 weeks of dose escalation period and 28 weeks of maintenance period), followed by a 5-week follow-up period.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 242 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 121 Participants |
| Sex: Female, Male Male | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 81 |
| other Total, other adverse events | 113 / 161 | 26 / 81 |
| serious Total, serious adverse events | 13 / 161 | 3 / 81 |
Outcome results
None listed