| Cagrilintide alone at a dose of 2.4 mg, or semaglutide at a dose of 2.4 mg combined with cagrilintide at a dose of 2.4 mg, plus lifestyle interventions, over 68 weeksThe trial randomised participants 21:3:3:7 to cagrilintide-semaglutide, semaglutide alone, cagrilintide alone or placebo. | Adults without diabetes with a BMI of 30 or higher, or 27 or higher with at least one obesity-related complication (REDEFINE 1, n=3417) | Not stated | |
| Once-weekly cagrilintide-semaglutide (2.4 mg each) or placebo, along with lifestyle intervention, for 68 weeksPatients were assigned in a 3:1 ratio to cagrilintide-semaglutide or placebo. | Adults with a body-mass index of 27 or more, a glycated hemoglobin level of 7 to 10%, and type 2 diabetes (REDEFINE 2, n=1206) | Not stated | |
| Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks, given with semaglutide as separate injections or combined in a single injectionRegistration text describing planned administration; the listing does not report results. | People with overweight or obesity enrolled in a completed phase 1 pharmacokinetic study (n=40) | Subcutaneous | |
| CagriSema 2.4 mgThe abstract reports the dose label used for stratified analysis but does not state route, schedule, titration, or treatment duration. | Participants with Type 2 diabetes in the included randomized trials, compared with placebo and with dose-matched semaglutide | Not stated | |
| semaglutide 2.4 mgUsed as the dose-matched comparator in the pooled analysis; the abstract does not state route or schedule. | Participants with Type 2 diabetes in the active-comparator arms of the included trials | Not stated | |
| semaglutide 2.4 mg monotherapyThe abstract states this comparator dose but does not report the cagrilintide or CagriSema dose, frequency, route, or treatment duration. | adults with overweight or obesity, with or without type 2 diabetes, in the comparator arms of the included randomised controlled trials | Not stated | |
| cagrilintide B subcutaneously once weekly for 5 weeksThe registration excerpt states no milligram amount for this version. | participants assigned to the cagrilintide B arm, described as adults living with excess body weight | Subcutaneous | |
| cagrilintide D subcutaneously once weekly for 5 weeksThe registration excerpt states no milligram amount for this version. | participants assigned to the cagrilintide D arm, described as adults living with excess body weight | Subcutaneous | |
| cagrilintide and semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeksNo milligram doses are stated in the registration text. | participants assigned to the CagriSema arm | Subcutaneous | |
| semaglutide and placebo matched to cagrilintide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeksNo milligram doses are stated in the registration text. | participants assigned to the semaglutide arm | Subcutaneous | |
| cagrilintide and placebo matching to semaglutide subcutaneously once-weekly after a dose escalation period of 16 weeks during the maintenance period for 10 weeksNo milligram doses are stated in the registration text. | participants assigned to the cagrilintide arm | Subcutaneous | |
| placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously once weekly for 26 weeksPlacebo contains no active ingredient, per the registration. | participants assigned to the placebo comparator arm | Subcutaneous | |
| CagriSema 2.4 mg/2.4 mg or placebo, plus standard of careThe abstract describes CagriSema as a fixed-dose combination administered subcutaneously once weekly; no titration schedule or treatment duration is stated. | Adults with established cardiovascular disease and body mass index 25.0 kg/m2 or higher, with or without type 2 diabetes | Subcutaneous | |
| Once-weekly subcutaneous injections of CagriSema at escalating doses every week in 8-week dose escalation period until target dose (dose 1) is achieved and maintained up to 32 weeksThe registration does not state the milligram amounts of cagrilintide or semaglutide in target dose 1. | Participants with type 2 diabetes treated with once-daily basal insulin with or without metformin, assigned to the CagriSema Dose 1 arm | Subcutaneous | |
| Once-weekly subcutaneous injections of CagriSema at escalating doses every week in 16-week dose escalation period until target dose (dose 2) is achieved and maintained up to 24 weeksThe registration does not state the milligram amounts in target dose 2. | Participants with type 2 diabetes treated with once-daily basal insulin with or without metformin, assigned to the CagriSema Dose 2 arm | Subcutaneous | |
| Once-weekly subcutaneous injection of placebo matched to CagriSema dose 1 or dose 2 for 40 weeks | Participants assigned to the two placebo comparator arms | Subcutaneous | |
| CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeksThe registration does not state the milligram amount corresponding to dose level 1. | Participants in the CagriSema dose level 1 arm, described as people living with obesity, with or without type 2 diabetes | Subcutaneous | |
| CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeksThe registration does not state the milligram amount corresponding to dose level 2. | Participants in the CagriSema dose level 2 arm, listed as an active comparator | Subcutaneous | |
| Semaglutide once weekly subcutaneously during the treatment period for 72 weeksNo dose amount is given for semaglutide in this excerpt. | Participants in the semaglutide comparator arm | Subcutaneous | |
| once-weekly CagriSema dose 1, administered subcutaneouslyThe registration labels this as dose 1 and does not state a milligram amount. | participants with type 2 diabetes previously treated with once-weekly subcutaneous semaglutide | Subcutaneous | |
| once-weekly CagriSema dose 2, followed by dose 1, administered subcutaneouslyDose levels are given only as labels; no numbers or units appear in the excerpt. | participants with type 2 diabetes previously treated with once-weekly subcutaneous semaglutide | Subcutaneous | |
| once-weekly CagriSema dose 3, followed by dose 2 and dose 1, administered subcutaneouslyDose levels are given only as labels; no numbers or units appear in the excerpt. | participants with type 2 diabetes previously treated with once-weekly subcutaneous semaglutide | Subcutaneous | |
| 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, then the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeksNo milligram amounts are stated in the source text. | children and adolescents with excess body weight assigned to the CagriSema arm | Subcutaneous | |
| 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, then the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeksNo milligram amounts are stated in the source text. | children and adolescents with excess body weight assigned to the cagrilintide arm | Subcutaneous | |
| 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 weeksThese participants do not continue into the extension study. | children and adolescents with excess body weight assigned to the semaglutide arm | Subcutaneous | |
| 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, then the same dose escalation regimen as CagriSema for 16 weeks and the same dose or MTD in the open-label extension phase for up to 140 weeksPlacebo is described as looking like the treatment being tested but without active ingredients. | children and adolescents with excess body weight assigned to the placebo comparator arm | Subcutaneous | |
| 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 weeksNo milligram amounts are stated in the registration excerpt. | Participants living with obesity randomised to the CagriSema arm in the main phase | Subcutaneous | |
| 1 of the 3 dose levels of CagriSema for 80 weeksThe specific dose levels are not disclosed; assignment is decided by chance. | Participants randomised to the CagriSema arm who continue into the extension phase | Subcutaneous | |
| Placebo matched to CagriSema subcutaneously once weekly for 80 weeksThese participants are described as receiving CagriSema with flexible dose escalation for 80 weeks in the extension phase. | Participants randomised to the placebo comparator arm in the main phase | Subcutaneous | |
| cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase; 97 weeks in the extension phaseThe excerpt states no milligram amounts for either component. | Participants randomised to the CagriSema experimental arm | Subcutaneous | |
| cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeksDouble-dummy design; no milligram amounts are stated. | Participants randomised to the cagrilintide active-comparator arm | Subcutaneous | |
| semaglutide s.c. and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeksNo milligram amounts are stated. | Participants randomised to the semaglutide active-comparator arm | Subcutaneous | |
| placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeksThis arm is listed as included in the extension phase for 97 weeks. | Participants randomised to the placebo comparator arm | Subcutaneous | |