Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CagriSema · 7 trials · 4 indications
Measured as count of events.
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 |
|---|---|---|
| CagriSema dose 1 | EXPERIMENTAL | Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1. |
| CagriSema dose 2 | EXPERIMENTAL | Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1. |
| CagriSema dose 3 | EXPERIMENTAL | Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1. |
| 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 | DRUG | CagriSema will be administered s.c. once weekly. |
| 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. |
| 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. |
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. * Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening. * Stable once-weekly dose ≥...
CagriSema is an investigational combination therapy being developed by Novo Nordisk for type 2 diabetes and obesity. It combines cagrilintide and semaglutide in a single treatment. CagriSema is in Phase 3 clinical development and has not been approved by the FDA. It is designed to address both blood sugar control and weight loss.
CagriSema is being studied for the treatment of type 2 diabetes and obesity. Clinical trials are evaluating its ability to lower blood sugar and reduce body weight in adults, and one trial is testing it in children and adolescents with type 2 diabetes. It remains investigational and is not yet approved for any indication.
CagriSema targets both the GLP-1 and amylin (AMY) pathways. It combines cagrilintide, an amylin analog, with semaglutide, a GLP-1 receptor agonist. This dual mechanism is intended to influence appetite regulation and glucose control, which are relevant to treating type 2 diabetes and obesity.
CagriSema is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is running the Phase 3 clinical program evaluating the combination of cagrilintide and semaglutide across obesity and type 2 diabetes populations.
CagriSema is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Novo Nordisk is conducting late-stage trials in type 2 diabetes and obesity, including studies in adults and in children and adolescents, with additional earlier-stage work ongoing.
CagriSema is being evaluated in several registered trials. These include NCT07817251, which studies switching from semaglutide to CagriSema in type 2 diabetes; NCT07564414, a weight-loss study in obesity with or without type 2 diabetes; NCT07282613, a pediatric type 2 diabetes trial; and NCT07184086, a metabolism study in obesity.