Nutritional, Metabolic, Endocrine
Conditions
Interventions
CagriSema 2.4 mg 7.2 mg
CagriSema 2.4 mg 2.4 mg
Semaglutide 7.2 mg
Sponsors
Novo Nordisk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria: • Male or female (sex assigned at birth, inclusive of all gender identities). • Age 18 years or above at the time of signing the informed consent. • Body Mass Index (BMI) = 35.0 kg/m2. • Participants without T2D (Sub-study 1): No history of T2D and glycated haemoglobin (HbA1c) < 6.5% (48 mmol/mol) Participants with T2D (Sub-study 2): A history of T2D and glycated haemoglobin (HbA1c) < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion criteria
Exclusion criteria: Key exclusion criteria: • A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records. • Use of any glucagon like peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in body weight (CagriSema s.c. 2.4 mg/7.2 mg versus CagriSema s.c. 2.4 mg/2.4 mg) From randomisation (week 0) to end of treatment (week 72) | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative change in body weight (CagriSema s.c. 2.4 mg/7.2 mg versus semaglutide s.c. 7.2 mg) (week 0) to end of treatment (week 72) ;Change in BMI From randomisation (week 0) to end of treatment (week 72) ;Achievement of =30% weight reduction (Sub-study 1 only) From randomisation (week 0) to end of treatment (week 72) ;Achievement of =25% weight reduction (Sub-study 1 only) From randomisation (week 0) to end of treatment (week 72) ;Achievement of =20% weight reduction (Sub-study 2 only) From randomisation (week 0) to end of treatment (week 72);Change in waist circumference From randomisation (week 0) to end of treatment (week 72);Change in systolic blood pressure From randomisation (week 0) to end of treatment (week 72) ;Mean change in body weight From randomisation (week 0) to end of treatment (week 72);Achievement of =20% weight reduction (only Sub-study 1) From randomisation (week 0) to end of treatment (week 72);Achievement of BMI < 30 kg/m2 From randomisation (week 0) to end of treatment (week 72) ;Achievement of BMI < 27 kg/m2 From randomisation (week 0) to end of treatment (week 72) ;Achievement of normal BMI (18.5 = BMI < 25) At end of treatment (week 72);Achievement of waist-to-height ratio of < 0.53 At end of treatment (week 72) ;Change in SBP From randomisation (week 0) to end of treatment (week 72) ;Ratio to baseline • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids • Non-HDL cholesterol From baseline (week 0) to end of treatment (week 72) ;Change in SF-36v2 physical Function From randomisation (week 0) to end of treatment (week 72) ;Change in IWQOL-Lite-CT physical function From randomisation (week 0) to end of treatment (week 72) ;Change in HbA1c From randomisation (week 0) to end of treatment (week 72) ;Achievement of HbA1c < 6.5% (only Sub-study 2) At end of treatment (week 72);Achievement of normal HbA1c < 5.7% At end of treatment (week 72);Number of TEAEs From ran | — |
Countries
South Africa
Contacts
Public ContactDarren Katzman
Director Clinical Medical and Regulatory
Outcome results
None listed