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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07220642 | Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | PHASE3 | ACTIVE NOT_RECRUITING | 300 | — | — | Nov 5, 2025 | Jun 29, 2027 | Apr 8, 2026 | 40 | United States, Argentina +8 |
| NCT06780449 | A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity | PHASE3 | ACTIVE NOT_RECRUITING | 400 | — | — | Feb 10, 2025 | Oct 31, 2028 | Jan 20, 2026 | 36 | United States, Belgium +4 |
| NCT06388187 | A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight | PHASE3 | COMPLETED | 300 | — | — | Jun 24, 2024 | Apr 22, 2026 | May 5, 2026 | 25 | United States, Canada +3 |
| NCT06131437 | A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight | PHASE3 | COMPLETED | 809 | — | — | Nov 27, 2023 | Jan 9, 2026 | Feb 6, 2026 | 46 | United States |
| NCT05567796 | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight | PHASE3 | ACTIVE NOT_RECRUITING | 3,400 | — | — | Nov 1, 2022 | Oct 19, 2026 | May 5, 2026 | 254 | United States, Argentina +21 |
| NCT07607587 | Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events | PHASE1 | NOT YET_RECRUITING | 114 | — | — | May 29, 2026 | Nov 19, 2027 | May 26, 2026 | 11 | United States |
| NCT07527195 | Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) | PHASE1 | RECRUITING | 100 | — | — | Apr 10, 2026 | Jun 9, 2028 | May 7, 2026 | 1 | Denmark |
| NCT07010432 | The Role of the Amylin Analogue Cagrilintide in Bone Metabolism | PHASE1 | RECRUITING | 144 | — | — | Jun 12, 2025 | May 3, 2028 | Jul 25, 2025 | 1 | Denmark |
| NCT06289504 | A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight | PHASE1 | COMPLETED | 34 | — | — | Feb 27, 2024 | Nov 15, 2024 | May 19, 2026 | 1 | Canada |
| NCT06207877 | A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight | PHASE1 | COMPLETED | 62 | — | — | Feb 23, 2024 | Nov 22, 2024 | Jan 8, 2026 | 1 | Germany |
| NCT05804162 | A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants | PHASE1 | COMPLETED | 107 | — | — | Apr 12, 2023 | Sep 18, 2023 | Nov 1, 2024 | 1 | Germany |
Measured as percentage (%) of body weight.
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Measured in micromoles per 100 grams per minute (μmol/100g/min).
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| Arm | Type | Description |
|---|---|---|
| Cagrilintide | EXPERIMENTAL | Participants will receive cagrilintide subcutaneously once weekly for 64 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks. |
| CagriSema | EXPERIMENTAL | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year. |
| CagriSema Dose 1 | EXPERIMENTAL | Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks. |
| Placebo Dose 1 | PLACEBO_COMPARATOR | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks. |
| CagriSema Dose 2 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks. |
| Placebo Dose 2 | PLACEBO_COMPARATOR | Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks. |
| CagriSema 2.4 mg/2.4 mg | EXPERIMENTAL | Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks. |
| Tirzepatide 15 mg | ACTIVE_COMPARATOR | Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks. |
| Semaglutide | ACTIVE_COMPARATOR | Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks. |
| Placebo s.c. | PLACEBO_COMPARATOR | Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks. |
| CagriSema +Atorvastatin + Warfarin | EXPERIMENTAL | Participants will receive a single dose of atorvastatin and a single dose of warfarin followed by a 16-week CagriSema dose escalation period and a 7-week CagriSema maintenance period. Participants will also receive a single dose of atorvastatin and a single dose of warfarin in the maintenance period. |
| Cagrilintide (Arm 1) | EXPERIMENTAL | Participants will receive 0.6 milligrams (mg) of cagrilintide subcutaneously once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose moxifloxacin placebo at the end of the treatment period will be administered orally. |
| Cagrilintide Placebo (Arm 2A) | ACTIVE_COMPARATOR | Participants will receive cagrilintide placebo subcutaenously once weekly. In addition, a single dose of moxifloxacin active prior to initiation of treatment and a single dose of moxifloxacin placebo at the end of the treatment period will be administered orally. |
| Cagrilintide Placebo (Arm 2B) | ACTIVE_COMPARATOR | Participants will receive cagrilintide placebo subcutaneously once weekly. In addition, a single dose of moxifloxacin placebo prior to initiation of treatment and a single dose of moxifloxacin active at the end of the treatment period will be administered orally. |
| Name | Type | Description |
|---|---|---|
| Cagrilintide | DRUG | Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
| Placebo | DRUG | Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling. |
| Semaglutide | DRUG | Participants will receive semaglutide subcutaneously. |
| Placebo cagrilintide | DRUG | Participants will receive placebo matched to cagrilintide subcutaneously. |
| Placebo semaglutide | DRUG | Participants will receive placebo matched to semaglutide subcutaneously. |
| Tirzepatide | DRUG | Tirzepatide will be administered subcutaneously. |
| Placebo (matched to Cagrilintide) | DRUG | Placebo matched to Cagrilintide will be administered subcutaneously. |
| Atorvastatin | DRUG | Atorvastatin will be administered as a single dose orally 2 times during the study. |
| Warfarin | DRUG | Warfarin will be administered as a single dose orally 2 times during the study. |
| Cagrilintide Placebo | DRUG | Participants will receive cagrilintide placebo subcutaneously once weekly. |
| Moxifloxacin | DRUG | Partcipants will receive a single dose of moxifloxacin orally. |
| Moxifloxacin Placebo | DRUG | Partcipants will receive a single dose of moxifloxacin orally. |
Inclusion criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study * Female or male (sex at birth) * Age 18 years or above at the time...