A combination of Novo Nordisk’s CagriSema injection for overweight people with type II diabetes resulted in a 15.6% body weight reduction compared to taking the drugs individually.
Novo Nordisk shared that its clinical trial of CagriSema, a combination injection for overweight people with type II diabetes, resulted in a 15.6% body weight reduction compared to the drugs dosed individually.
The Phase II study evaluated the safety and efficacy of CagriSema, which consists of 2.4 mg semaglutide and 2.4 mg cagrilintide in one subcutaneous injection. The combination drug, designed for once-weekly dosing, was compared with the dosing of 2.4 mg of semaglutide and 2.4 mg cagrilintide individually once a week. The trial consisted of 92 participants who were randomized into three cohorts, with an 8.4% mean baseline Hemoglobin A1c (HbA1c) and a mean baseline body weight of 106 kg.
During the 32-week observation period, those who received the combination were seen to have a 2.18%-point reduction in HbA1c. This was compared to the recipients of the individual drug regimen who saw a 1.79%-point drop. Body weight reduction was 15.6% in the combination group versus 5.1% in the semaglutide-only group and 8.1% in the cagrilintide-only group.
“We are encouraged by the impressive phase 2 results for CagriSema in people with type 2 diabetes,” Martin Holst Lange, executive vice president for development at Novo Nordisk said in a statement. “The results indicate that CagriSema reduces blood sugar more than semaglutide alone and the weight loss seen in the trial confirms the substantial weight lowering potential of CagriSema.”
Novo Nordisk is now preparing to launch a Phase III development program for CagriSema in 2023 for patients diagnosed with type II diabetes. Meanwhile, the Phase III program for people who are obese and overweight is expected to begin in November, still with a once-weekly dose.
The primary endpoint for this trial is a relative change in body weight from week zero to week 68. Secondary endpoints include the achievement of 20% or more weight reduction, a relative change in body weight and change in waist circumference, among others. The study is open to participants ages 18 years and older with a body mass index of 17 kg/m^2 or more and diagnosed with type II diabetes mellitus, among other factors.
Novo Nordisk is a leader in the fight against obesity. In August, the company selected Digbi Health to participate in its Global Prevention Accelerator Program to pilot test solutions in the prevention of obesity and related cardiometabolic disorders. Digbi will evaluate the possibility of using multiomic1 and lifestyle data to predict a person’s risk for obesity.
In January, the company partnered with EraCal Therapeutics to develop obesity-linked drug targets. EraCal’s lead product, Era-107, which is designed to be an appetite suppressant, is expected to commence first-in-human trials before the end of the year.
