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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1266-2400 | Other Identifier | World Health Organization (WHO) |
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This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Participants will either get semaglutide or placebo once daily morning for 44 weeks.
In addition to taking the medicine, participants will have talks with study staff about:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide 50 mg | Experimental | Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44). |
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| Semaglutide Placebo | Placebo Comparator | Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Participants will receive semaglutide tablets orally once daily for 44 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Body Weight | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 44) |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent | Measured as count of participants | At end of treatment (week 44) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent | Measured as count of participants | At end of treatment (week 44) |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent |
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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.
Male or female, age greater than or equal to 18 years at the time of signing informed consent.
Body mass index (BMI) of
History of at least one self-reported unsuccessful dietary effort to lose body weight.
For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4:
Exclusion Criteria:
Participants without T2D at screening:
Participants with T2D at screening:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital-Endocrinology | Beijing | Beijing Municipality | 100044 | China | ||
| Beijing Friendship Hospital, Capital Medical University-Endocrinology |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Semaglutide Placebo | Drug | Participants will receive placebo matched to semaglutide. |
|
Measured as count of participants |
| At end of treatment (week 44) |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent | Measured as count of participants | At end of treatment (week 44) |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Physical Function Domain | IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score. | From baseline (week 0) to end of treatment (week 44) |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite- CT) - Total score | IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score. | From baseline (week 0) to end of treatment (week 44) |
| Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score | IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual. | From randomisation (week 0) to end-of-treatment (week 44) |
| Change in Body Mass Index (BMI) | Measured in kilogram per square meter (kg/m^2) | From baseline (week 0) to end of treatment (week 44) |
| Change in Waist Circumference | Measured in centimeter (cm) | From baseline (week 0) to end of treatment (week 44) |
| Change in Systolic Blood Pressure | Measured in millimeter of mercury (mmHg) | From baseline (week 0) to end of treatment (week 44) |
| Change in Diastolic Blood Pressure | Measured in mmHg | From randomisation (week 0) to end of treatment (week 44) |
| Change in Glycated Haemoglobin (HbA1c) | Measured in percentage point (%-point) | From baseline (week 0) to end of treatment (week 44) |
| Change in Fasting Plasma Glucose | Measured as milligrams per decilitre (mg/dL) | From baseline (week 0) to end of treatment (week 44) |
| Change in Fasting Serum Insulin | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in Total Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in High-density Lipoprotein (HDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in Low-density Lipoproteins (LDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in Very Low-density Lipoproteins (VLDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in Triglycerides | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in Free Fatty Acids | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in High Sensitivity C-reactive Protein (hsCRP) | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) |
| Change in waist-height ratio (WtHR) | From baseline (week 0) to end of treatment (week 44) |
| Number of Treatment Emergent Adverse Events(TEAE's) | Measured as count of events | From baseline (week 0) to end of treatment (week 44) |
| Number of Treatment Emergent Serious Adverse Events(TESAE's) | Measured as count of events | From baseline (week 0) to end of study (week 51) |
| AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State | Measured as hours*nanomoles per litre (h*nmol/L) | Week 20 |
| Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg | Measured as nanomoles per litre (nmol/L) | Week 20 |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404000 | China |
| Huizhou Central People's Hospital-Endocrinology | Huizhou | Guangdong | 516001 | China |
| Huaihe Hospital of Henan University-Endocrinology | Kaifeng | Henan | 475000 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 450062 | China |
| Taihe Hospital-Endocrinology | Shiyan | Hubei | 442008 | China |
| The First People's Hospital of Changde City-Endocrinology | Changde | Hunan | 415003 | China |
| Changzhou No.2 People's Hospital | Changzhou | Jiangsu | 213003 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212001 | China |
| Jinan Central Hospital | Ji'nan | Shandong | 250013 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Huashan Hospital Fudan University-Endocrinology | Shanghai | Shanghai Municipality | 200040 | China |
| Shanghai Pudong New Area People's Hospital-Endocrinology | Shanghai | Shanghai Municipality | 201200 | China |
| General Hospital of Tianjin Medical University-Endocrinology | Tianjin | Tianjin Municipality | 300052 | China |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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