Novo Nordisk's CagriSema Delivers 23% Weight Loss In Trial But Still Trails Eli Lilly's Tirzepatide

Novo Nordisk announced the results of the REDEFINE 4 trial. The 84-week trial compared CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) to tirzepatide (sold as Mounjaro or Zepbound by Eli Lily) 15 mg. Both of these were administered once-weekly and subcutaneously. The trial found that if all people adhered to the treatment, CagriSema achieved a weight loss of 23.0% after 84 weeks compared to 25.5% with tirzepatide 15 mg. On the other hand, CagriSema achieved a weight loss of 20.2% compared to 23.6% with tirzepatide at 84 weeks, regardless of treatment adherence.

What Is CagriSema?

CagriSema is a once-weekly subcutaneous injection, which is being investigated by Novo Nordisk as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long acting amylin analogue, cagrilintide 2.4 mg and semaglutide 2.4 mg. The two molecules induce weight loss by reducing hunger, increasing feelings of fullness and thereby help people eat less and reduce their calorie intake.

The REDEFINE 4 Trial

The trial included 809 randomised people with obesity and one or more comorbidities and with a mean baseline body weight of 114.2 kg. The trial had an open-label design, meaning that all investigators and participants were aware of the specific drug administered throughout the trial. Novo Nordisk said that the trial did not achieve its primary endpoint of demonstrating noninferiority on weight loss for CagriSema compared to tirzepatide after 84 weeks.

Martin Holst Lange, executive vice president, R&D and chief scientific officer at Novo Nordisk, said, "We are pleased with the weight loss of 23% for CagriSema in this open-label trial. CagriSema has the potential to be the first GLP-1/amylin-combination product to reach the market for people living with obesity, documenting that cagrilintide adds to the existing benefits of semaglutide and offers clinically meaningful additive weight loss effects superior to what has been observed with GLP-1 biology alone."

CagriSema 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.

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