The Phase II trial evaluated Novo Nordisk’s CagriSema to treat individuals with type 2 diabetes. Credit: Novo Nordisk A/S.

Novo Nordisk has concluded the Phase II clinical trial of CagriSema for treating individuals with type 2 diabetes and reported headline results from the trial.

CagriSema is a combination of semaglutide and a new amylin analogue, cagrilintide, administered subcutaneously once a week.

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The trial analysed the safety and efficacy of a once-a-week fixed dose combination of CagriSema, comprising 2.4mg semaglutide and 2.4mg cagrilintide, versus the individual components semaglutide 2.4mg and cagrilintide 2.4mg.

It enrolled 92 subjects with type 2 diabetes and who were overweight. 

Subjects were randomised equally into the three treatment arms of the trial. 

According to the findings, following 32 weeks of treatment, subjects who received CagriSema attained a 2.18%-points numerically greater decline in HbA1c versus 1.79%-points and 0.93%-points for semaglutide and cagrilintide alone, respectively. 

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Subjects in the CagriSema arm had a 15.6% numerically greater decline in body weight versus 5.1% and 8.1% with semaglutide and cagrilintide, respectively. 

CagriSema was found to be safe and well-tolerated in the trial.

Novo Nordisk Development executive vice-president Martin Holst Lange said: “We are encouraged by the impressive Phase II results for CagriSema in people with type 2 diabetes. 

“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.”

Based on the latest data, the company anticipates commencing a Phase III development programme for CagriSema in type 2 diabetes patients next year. 

REDEFINE, another Phase III programme of CagriSema (2.4mg semaglutide and 2.4 mg cagrilintide) in overweight and obese individuals is projected to commence in the fourth quarter of this year.

In March last year, the company expanded clinical collaboration with Gilead Sciences in non-alcoholic steatohepatitis to carry out a larger clinical trial.