Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as CagriSema (Cagrilintide B and Semaglutide I)
CagriSema · 6 trials · 4 indications
Measured as percentage (%) of HbA1c.
Measured as percentage (%).
Measured as score on a scale.
Measured as kilojoules (kJ) per day.
Measured in hours\*nanomoles per liter (h\*nmol/L).
Measured in nanomoles per liter (nmol/L).
Measured in h\*nmol/L.
Measured in nmol/L.
| Arm | Type | Description |
|---|---|---|
| Part 1: CagriSema | EXPERIMENTAL | Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1. |
| Part 2: CagriSema | EXPERIMENTAL | Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2. |
| Cagrisema - dose level 1 | EXPERIMENTAL | Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks. |
| Cagrisema - dose level 2 | ACTIVE_COMPARATOR | Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks. |
| CagriSema | EXPERIMENTAL | Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks. |
| CagriSema (Cagrilintide + Semaglutide) / CagriSema | EXPERIMENTAL | Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. |
| Low Energy Diet (LED) / CagriSema | EXPERIMENTAL | Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks. |
| Treatment sequence 1 | EXPERIMENTAL | Participants will receive a single subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 1 followed by a single s.c. dose of CagriSema A in PDS290 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
| Treatment sequence 2 | EXPERIMENTAL | Participants will receive a single s.c. dose of CagriSema A in PDS290 pen-injector in period 1 followed by a single s.c. dose of CagriSema (cagrilintide B and semaglutide I) in DV3384 pen-injector in period 2 separated by a wash out period of minimum 7 weeks. |
| Name | Type | Description |
|---|---|---|
| CagriSema (Cagrilintide B and Semaglutide I) | DRUG | Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector. |
| Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) | DRUG | Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector. |
| Cagrisema | DRUG | Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously. |
| CagriSema (Cagrilintide B + semaglutide I) | DRUG | Cagrilintide and semaglutide will be administered subcutaneously. |
| Low Energy Diet | BEHAVIORAL | Participants will receive dietary intervention as per diet intervention manual. |
| CagriSema A | DRUG | Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector. |
Key Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including acti...
CagriSema is an investigational drug being studied for obesity and type 2 diabetes. In clinical trials, it is evaluated for weight loss and maintenance in people with obesity, and for lowering blood sugar and body weight in children and adolescents with type 2 diabetes. It is also being studied in adults with type 2 diabetes and painful diabetic peripheral neuropathy.
CagriSema is a combination of cagrilintide B and semaglutide I. Cagrilintide is a long-acting amylin analog, and semaglutide is a GLP-1 receptor agonist. Together, they target pathways involved in appetite regulation and glucose control, which supports their study in obesity and type 2 diabetes.
CagriSema is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. Novo Nordisk is conducting clinical trials to evaluate the safety and efficacy of CagriSema for obesity and type 2 diabetes.
CagriSema is in Phase 3 clinical development. It is being studied in Phase 3 trials for obesity and type 2 diabetes, including a long-term weight loss study in adults with obesity and a study in children and adolescents with type 2 diabetes. It is investigational and not yet approved.
CagriSema has four clinical trials. NCT06716307 is a completed Phase 1 study in adults with overweight or obesity. NCT06797869 is an active Phase 2 study in type 2 diabetes and painful diabetic peripheral neuropathy. NCT07011667 is an active Phase 3 obesity study. NCT07282613 is a Phase 3 study in children and adolescents with type 2 diabetes.
Yes, CagriSema is also known as CagriSema (Cagrilintide B and Semaglutide I) and CagriSema (Cagrilintide B + semaglutide I). These names refer to the same combination product being developed by Novo Nordisk for obesity and type 2 diabetes.