Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07564414 | A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight | PHASE3 | RECRUITING | 2,500 | — | — | May 21, 2026 | Apr 19, 2028 | May 29, 2026 | 303 | United States, Argentina +17 |
| NCT07011667 | A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term | PHASE3 | ACTIVE NOT_RECRUITING | 609 | — | — | Jun 3, 2025 | Oct 17, 2028 | Dec 12, 2025 | 46 | United States |
| NCT07184086 | A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet | PHASE1 | RECRUITING | 80 | — | — | Sep 26, 2025 | Oct 12, 2027 | Oct 8, 2025 | 2 | United States |
| NCT06716307 | A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity | PHASE1 | COMPLETED | 18 | — | — | Dec 2, 2024 | May 22, 2025 | Aug 27, 2025 | 1 | United States |
Measured as percentage (%).
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 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 (Cagrilintide and Semaglutide) will be administered subcutaneously. |
| Semaglutide | DRUG | Semaglutide will be administered subcutaneously. |
| CagriSema (Cagrilintide B and Semaglutide I) | DRUG | CagriSema (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 (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. * BMI≥ 35.0 kg/m\^2. * Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participan...