On Friday, Novo Nordisk A/S (NYSE:NVO) stock plunged after the company released headline results from the REDEFINE 1 Phase 3 trial in the global REDEFINE program.
REDEFINE 1 is a 68-week efficacy and safety trial investigating subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to the individual components cagrilintide 2.4 mg, semaglutide 2.4 mg, and placebo, all administered once-weekly.
Also Read: Novo Nordisk's Ozempic Label Expansion Snags Approval From European Drug Regulator's Advisory Panel
The trial included 3,417 randomized people with obesity or overweight with one or more comorbidities and a mean baseline body weight of 106.9 kg.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss with CagriSema versus placebo at week 68.
When evaluating the effects of treatment if all people adhered to treatment, people treated with CagriSema achieved a weight loss of 22.7% after 68 weeks compared to a reduction of 11.8% with cagrilintide 2.4 mg, 16.1% with semaglutide 2.4 mg and 2.3% with placebo alone.
In November, Novo Nordisk said its hybrid drug, CagriSema, aims to reduce weight by 25% without added side effects.
In addition, 40.4% of patients who received CagriSema reached a weight loss of 25% or more after 68 weeks, compared to 6.0% with cagrilintide 2.4 mg, 16.2% with semaglutide 2.4 mg, and 0.9% with placebo.
When applying the treatment policy estimand, people treated with CagriSema achieved a weight loss of 20.4% compared to a reduction of 11.5% with cagrilintide 2.4 mg, 14.9% with semaglutide 2.4 mg and 3.0% with placebo.
In the trial, CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg appeared to have a safe and well-tolerated profile. The most common adverse events with CagriSema were gastrointestinal, and the vast majority were mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
The results from the second pivotal phase 3 trial, REDEFINE 2, in adults with type 2 diabetes and either obesity or overweight are expected during the first half of 2025.
In reaction to lower-than-expected trial data, Eli Lilly And Co (NYSE:LLY) stock is trading higher. Lilly's own obesity injection containing tirzepatide demonstrated sustained average weight loss of 22.9% (15 mg dose) through the three-year treatment period for the efficacy estimandi.
Recently, Novo Nordisk stock came under pressure when two new studies from the University of Southern Denmark suggested that Ozempic, a diabetes medication, may increase the risk of developing a rare eye condition.
Price Action: NVO stock is down 16.50% at $86.33, and LLY stock is up 8.91% at $825 during the premarket session at the last check on Friday.
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