Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cagrilintide · 28 trials · 11 indications
Measured as percentage (%).
Measured in percentage (%).
Measured in percentage points.
Measured as count of participant.
Measured in percentage (%).
Measured in percentage-points.
Measured in percentage (%)
Measured as count of participants
Measured in days.
Count of participant.
Measured in percentage (%)
Measured as count of participants
Measured in ratio to baseline.
Measured as percentage of participants.
Measured in percentage (%).
Measured in micromoles per 100 grams per minute (μmol/100g/min).
Measured in percentage (%).
Measured in hours\*nanomoles per liter (hours\*nmol/L).
Measured in hours\*nmol/L.
Measured in percentage (%).
Measured in millimeter. VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm. The appetite score will be calculated as \[hunger + (100 - satiety) + (100 - fullness) + prospective food consumption\]/4. Scores of 0 mm are worst and scores of 100 mm are best.
Measured in millisecond
Measured in nanomoles \* hours per liter (nmol\*h/L)
measured in nmol⸱h/L
measured in nmol/L
measured in nmol⸱h/L
measured in nmol/L
| Arm | Type | Description |
|---|---|---|
| Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2 | EXPERIMENTAL | Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks. |
| Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | EXPERIMENTAL | Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
| Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1 | PLACEBO_COMPARATOR | Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks. |
| CagriSema | EXPERIMENTAL | Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks. |
| Semaglutide | EXPERIMENTAL | Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. |
| Cagrilintide | EXPERIMENTAL | Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks. |
| Tirzepatide | EXPERIMENTAL | Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks. |
| 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 Dose 1 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks. |
| Semaglutide Dose 2 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks. |
| Cagrilintide Dose 1 | ACTIVE_COMPARATOR | Participants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks. |
| Semaglutide 2.4 mg | ACTIVE_COMPARATOR | Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) 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. |
| Placebo Cagrilintide | PLACEBO_COMPARATOR | Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 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. |
| Part A | OTHER | Participants will not get any medicine during this study. |
| Part B | EXPERIMENTAL | Participants will receive CagriSema or placebo (Dose 1,2,3,4) for 16-weeks dose-escalation period followed by 37-weeks intervention period on CagriSema or placebo (Dose 5) that includes a 12-day standardised energy intake 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. |
| Part A: Participants with normal hepatic function | EXPERIMENTAL | Participants with normal hepatic function will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. |
| Part A: Participants with mild hepatic impairment | EXPERIMENTAL | Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. |
| Part A: Participants with moderate hepatic impairment | EXPERIMENTAL | Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. |
| Part A: Participants with severe hepatic impairment | EXPERIMENTAL | Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous (s.c.) dose of 0.9 milligrams (mg) of cagrilintide on Day 1. |
| Part B: Sequence 1 | EXPERIMENTAL | Healthy participants will receive a single dose of cagrilintide Dose 1 intravenously (i.v) at the first dosing visit (Day 1), followed by a single dose of cagrilintide Dose 2 s.c. at the second dosing visit (Day 53). |
| Part B: Sequence 2 | EXPERIMENTAL | Healthy participants will receive a single dose of cagrilintide Dose 2 s.c. at the first dosing visit (Day 1), followed by a single dose of cagrilintide Dose 1 i.v at the second dosing visit (Day 53). |
| Part A: Cagrilintide and semaglutide in separate syringes | EXPERIMENTAL | Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period. |
| Part A: Cagrilintide and semaglutide combined in DV3384 device | EXPERIMENTAL | Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period. |
| Part B: Cagrilintide and semaglutide combined in DV3384 device | EXPERIMENTAL | Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period. |
| Name | Type | Description |
|---|---|---|
| Cagrilintide | DRUG | Cagrilintide will be administered subcutaneously. |
| Placebo cagrilintide | DRUG | Placebo matched to cagrilintide will be administered subcutaneously. |
| Placebo semaglutide | DRUG | Placebo matched to semaglutide will be administered subcutaneously. |
| Semaglutide | DRUG | Participants will receive semaglutide subcutaneously. |
| Placebo (matched to Cagrilintide) | DRUG | Placebo matched to 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. |
| Tirzepatide | DRUG | Participants will receive once-weekly tirzepatide 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. |
| No treatment given | OTHER | Participants will not get any medicine during this study. |
| Cagrilintide and Semaglutide | DRUG | Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide. |
| 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. * Male or female (sex assigned at birth, inclusive of all gender i...
Cagrilintide is an investigational drug being studied for overweight, obesity, and type 2 diabetes. It is also being evaluated in conditions such as cardiovascular disease, hepatic impairment, and chronic kidney disease. The drug is in Phase 3 clinical development for these indications.
Cagrilintide is a peptide-based drug, classified under the -tide (peptide) target class. It is being studied for its effects on weight loss and glycemic control in people with excess body weight and type 2 diabetes.
Cagrilintide is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy.
Cagrilintide is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for conditions including obesity, type 2 diabetes, and related metabolic disorders.
Cagrilintide is being studied in several clinical trials. One Phase 3 trial (NCT05394519) evaluated CagriSema for weight loss in people with type 2 diabetes and excess body weight. Another Phase 3 trial (NCT07220759) is studying weight loss with Cagrilintide in overweight or obese people with type 2 diabetes. A Phase 3 trial (NCT07745504) is comparing two versions of injectable Cagrilintide against placebo.
Cagrilintide is a component of CagriSema, which is a combination product being studied in clinical trials. CagriSema contains cagrilintide and is being evaluated for weight loss in people with type 2 diabetes and excess body weight.