The compound formulation of semaglutide CagriSema approved for clinical trials
On January 26, according to the official website of CDE, Novo Nordisk CagriSema injection was approved for clinical use and intended to be used for adult type 2 diabetes patients with poor blood glucose control. It can be seen that Novo Nordisk, a global biopharmaceutical giant, is laying out the next potential weight-loss combination therapy “CagriSema” in order to build greater advantages in the diabetes and weight loss market.
CagriSema Injection is a compound formulation that contains two components: the new generation GLP-1 drug Semaglutide and the long-acting amylin analogue Cagrilintide.
The clinical results of CagriSema Phase II are positive, with an expected weight loss of 25%
CagriSema completed Phase II clinical trials in August 2022, which demonstrated its safety and efficacy.
The purpose of this trial is to evaluate the efficacy and safety of the fixed dose combination of CagriSema (2.4 mg semaglutide+2.4 mg cagrilintide) in overweight type 2 diabetes patients compared with semaglutide alone (2.4 mg) or cagrilintide alone (2.4 mg). A total of 92 patients were enrolled and randomly assigned to three groups, all receiving medication once a week. The baseline measurement showed an average HbA1c level of 8.4% and an average body weight of 106 kilograms.
Cagrisema phase 2
After 32 weeks of treatment, the HbA1c levels of patients in the CagriSema group decreased by 2.18%, while those in the Semaglutide and Cagrilintide groups decreased by 1.79% and 0.93%, respectively. In addition, the weight loss in the CagriSema group was 15.6%, while the weight loss in the Semaglutide and Cagrilintide groups was 5.1% and 8.1%, respectively.
Interestingly, although it is a combination therapy, CagriSema exhibits safety and tolerability comparable to or even better than the standalone drugs of Semaglutide and Cagrilintide. Compared to combination therapy, discontinuation of a single drug and severe side effects are more common.
Cagrisema phase 3
On November 14, 2023, Novo Nordisk registered a phase III clinical trial of CagriSema and tirzepatide head to head control for weight loss on the Clinicaltrials.gov website. The Phase III clinical plan enrolls 800 obese or overweight patients. It will be completed by August 2025. The patient will receive high-dose treatment of 2.4mg Cagrilintide+2.4mg Semaglutide or Tirzepatide 15mg.
Cagrisema phase 3
Novo Nordisk has carried out a number of phase III clinical trials around CagriSema in type II diabetes and weight loss indications. Compared to Semaglutide monotherapy, CagriSema has significantly improved weight loss and hypoglycemic effects.
Novo Nordisk disclosed at the investor meeting at the end of June, CagriSema may reduce the weight of non diabetes obese patients by at least 25% in the cagrisema phase 3.
