Adults with obesity lost 22.7% of body weight with combination GLP-1/amylin analog
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Key takeaways:
- CagriSema induced superior weight loss compared with placebo for adults with obesity in the REDEFINE 1 trial.
- The medication’s safety profile was similar to other GLP-1 receptor agonists.
A combination GLP-1/amylin analog conferred a superior reduction in body weight at 68 weeks vs. placebo for adults with obesity or overweight with at least one weight-related comorbidity, according to top-line results from a phase 3 trial.
CagriSema (Novo Nordisk) is a subcutaneous drug consisting of a fixed combination dose of cagrilintide 2.4 mg and semaglutide 2.4 mg (Wegovy). In the REDEFINE 1 trial, 3,417 adults with overweight or obesity and without diabetes were randomly assigned to once-weekly CagriSema, cagrilintide 2.4 mg, semaglutide 2.4 mg or placebo for 68 weeks.
In the trial product estimand, adults receiving CagriSema achieved a 22.7% weight loss at 68 weeks compared with a 16.1% weight reduction with semaglutide, a 11.8% drop in body weight with cagrilintide and a 2.3% weight loss with placebo. The proportion of adults who lost 25% or more of their body weight at 68 weeks was 40.4% for adults receiving CagriSema, 16.2% for those in the semaglutide-only group, 6% for those receiving cagrilintide alone and 0.9% for the placebo group.
The REDEFINE 1 trial used a flexible protocol in which participants were able to modify their dose. At 68 weeks 57.3% of adults receiving CagriSema reached the highest dose compared with 82.5% of people in the cagrilintide group and 70.2% of those in the semaglutide group.
According to a press release, CagriSema was deemed to be safe and well tolerated. The most common adverse events were gastrointestinal in nature and mild to moderate in severity. They were consistent with adverse events observed with other GLP-1 receptor agonist medications.
Though the FDA approval of semaglutide and tirzepatide (Zepbound, Eli Lilly) give health care professionals multiple pharmacotherapy options for treating obesity, Katherine H. Saunders, MD, DABOM, co-founder of FlyteHealth and an obesity medicine physician at Weill Cornell Medicine, said the heterogeneity of obesity means there’s a need for additional medications, including potentially CagriSema.
“Since obesity is a complex, heterogeneous disease, people have variable responses to treatment,” Saunders told Healio. “In addition, our treatment choices are limited by cost, coverage and supply. When one medication isn't effective or isn't an option due to cost, coverage or supply, we move on to the next medication option. Obesity medicine clinicians need all the treatment options we can get to provide the best care possible.”
Results from another phase 3 trial, REDEFINE 2, are expected in the first half of 2025. REDEFINE 2 is a 68-week trial comparing CagriSema with placebo among approximately 1,200 adults with type 2 diabetes plus overweight or obesity. CagriSema is also being investigated in REDEFINE 3, a cardiovascular outcomes trial enrolling about 7,000 adults with established cardiovascular disease with or without type 2 diabetes.
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