Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female. - Age above or equal to 18 years at the time of signing informed consent. - BMI above or equal to 30.0 kg/m^2. - Diagnosed with T2D above or equal to 180 days prior to the day of screening. - History of at least one self-reported unsuccessful dietary effort to lose body weight. - HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records. - Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. - Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m^2 (< 45 mL/min/1.73 m^2 in participants treated with SGLT2i) according to CKD-EPI creatinine equation as defined by KDIGO 20121 by the central laboratory at screening. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before 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. Efficacy and safety data will be collected at regular intervals throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To demonstrate the superiority of semaglutide s.c. 7.2 mg once weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity, with respect to relative change in body weight after 72 weeks, in adults with obesity and T2D - To demonstrate the superiority of semaglutide s.c. 7.2 mg once weekly versus placebo as an adjunct to a reduced calorie diet and increased physical activity, with respect to achieving body weight reduction = 5% after 72 weeks, in adults with obesity and T2D.;Secondary Objective: In adults with obesity and T2D – for semaglutide s.c. 7.2 mg once weekly as an adjunct to a reduced-calorie diet and increased physical activity: To demonstrate the superiority: a) versus placebo, - with respect to: -achieving body weight reduction = 10%, 15%, 20% respectively after 72 weeks. -change in waist circumference and HbA1c after 72 weeks -To compare the efficacy versus placebo, on other factors related to body weight, on cardiovascular risk factors, on glucose metabolism after 72 weeks. - To compare safety versus placebo to pulse after 72 weeks - To compare the safety and tolerability versus placebo and versus semglutide s.c. 2.4 mg after 81 weeks respectively. - To compare the safety versus placebo and versus semglutide s.c. 2.4 mg, with respect to severe hypoglycaemic episodes, after 81 weeks.;Primary end point(s): 1. Relative change in body weight 2. =5% body weight reduction (yes/no);Timepoint(s) of evaluation of this end point: 1-2. From baseline (week 0) to end of treatment (week 72) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. =10% body weight reduction (yes/no) 2. =15% body weight reduction (yes/no) 3. =20% body weight reduction (yes/no) 4. Change in waist circumference 5. Change in HbA1c 6. Change in body weight 7. Change in BMI 8. Change in systolic blood pressure 9. Change in diastolic blood pressure 10. Change in total cholesterol 11. Change in high-density lipoprotein (HDL) cholesterol 12. Change in low-density lipoprotein (LDL) cholesterol 13. Change in very-low-density lipoprotein (VLDL) cholesterol 14. Change in triglycerides 15. Change in free fatty acids 16. Change in high-sensitivity c reactive protein (hsCRP) 17. Change in fasting plasma glucose 18. Change in fasting serum insulin 19. HbA1c < 7.0 % (53 mmol/mol) 20. HbA1c = 6.5 % (48 mmol/mol) 21. Number of Adverse Events (AEs) 22. Number of Serious Adverse Events (SAEs) 23. Change in pulse 24. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes;Timepoint(s) of evaluation of this end point: 1 - 20. From baseline (week 0) to end of treatment (week 72) 21 - 22.From baseline (week 0) to end of study (week 81) 23. From baseline (week 0) to end of treatment (week 72) 24. From baseline (week 0) to end of treatment (week 81) | — |
Countries
Bulgaria, Canada, European Union, Hungary, Portugal, Slovakia, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed