Global pharmaceutical giant Novo Nordisk has announced that its fixed-dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) has demonstrated statistically significant efficacy in achieving weight loss among adults with obesity and type 2 diabetes.
About the drug
CagriSema is a once-weekly subcutaneous injection that combines a long-acting amylin analog, cagrilintide 2.4 mg, and semaglutide 2.4 mg, a glucagon-like peptide 1 (GLP-1) analog.
The two molecules promote weight loss by reducing hunger and increasing feelings of fullness, as a result helping people eat less and reduce their calorie intake.
About the study
The promising results stem from a phase III clinical trial coded REDEFINE 2—a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema versus placebo in 1,200 adults with type 2 diabetes and either obesity or overweight.
When evaluating the effects of treatment, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo.
Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo.
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When applying the treatment policy estimand, people treated with CagriSema achieved a superior weight loss of 13.7% compared to 3.4% with placebo.
In the trial, CagriSema appeared to have a safe and well-tolerated profile.
The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
What was said
"The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes," said Martin Holst Lange, executive vice president for Development at Novo Nordisk. "We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need."
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APR Team
African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.
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