Health Condition 1: null- Obesity Health Condition 2: E65-E68- Overweight, obesity and other hyperalimentation
Conditions
Interventions
Intervention1: Semaglutide: 2.4mg Semaglutide once weekly prefilled pen injector for sub cutaneous injection.
Total duration of therapy would be 18 months.
Control Intervention1: Placebo: 2.4mg place
Sponsors
Novo Nordisk AS
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial 2. Male or female, age >= 18 years at the time of signing informed consent 3. Body mass index (BMI) >= 30 kg/m2 or >= 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease 4. History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion criteria
Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: Glycaemia-related: 1. HbA1c >= 48 mmol/mol (6.5%) as measured by the central laboratory at screening 2. History of type 1 or type 2 diabetes mellitus 3. Treatment with glucose-lowering agent(s) within 90 days before screening 4. Treatment with a GLP-1 receptor agonist within 180 days before screening. Obesity-related: 5. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records 6. Treatment with any medication for the indication of obesity within the past 90 days before screening 7. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening 8. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or Mental health: 9. History of major depressive disorder within 2 years before screening 10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) 11. A Patient Health Questionnaire-9 (PHQ-9) score of >= 15 at screening 12. A lifetime history of a suicidal attempt 13. Suicidal behaviour within 30 days before screening 14. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening. General safety: 15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening 16. Presence of acute pancreatitis within the past 180 days prior to the day of screening 17. History or presence of chronic pancreatitis 18. Calcitonin >= 100 ng/L as measured by the central laboratory at screening 19. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 20. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR 21. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed 22. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening 23. Subject presently classified as being in New York Heart Association (NYHA) Class IV 24. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 25. Known or suspected abuse of alcohol or recreational drugs 26. Known or suspected hypersensitivity to trial product(s) or related products 27. Previous participation in this trial. Participation is defined as signed informed consent 28. Participation in another clinical trial within 90 days before screening <b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline at week 0 to week 68 in body weight (%) 2. Subjects who after 68 weeks achieve (yes/no): 3. Body weight reduction â?¥ 5% from baseline at weekTimepoint: 68 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at week 0 to week 68Timepoint: 1. Waist circumference (cm) (68 Weeks) 2. Systolic blood pressure (mmHg) (68 Weeks) 3. Physical functioning score (SF-36) (68 Weeks) 4. Physical function domain (5-items) score (IWQoL-Lite for CT) (68 Weeks) 5. Body weight (kg) (68 Weeks) 6. BMI (kg/m2) (68 Weeks);Subjects who after 68 weeks achieveTimepoint: 1.Body weight reduction â?¥ 10% from baseline at week 0 (68 Weeks) 2.Body weight reduction â?¥ 15% from baseline at week 0 (68 Weeks) | — |
Countries
Argentina, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Japan, Mexico, Poland, Russian Federation, Taiwan, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
NOVO NORDISK INDIA PVT LTD.
Outcome results
None listed