Novo Nordisk’s CagriSema highlights a 23% weight loss in REDEFINE 4 trial in patients with obesity

Novo Nordisk has recently announced their new headline results from REDEFINE 4, an open-label phase 3 trial from the global REDEFINE clinical trial programme.

Note that REDEFINE 4 was an 84-week trial investigating CagriSema compared to tirzepatide 15 mg, both administered once-weekly and subcutaneously. 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.

In addition when evaluating the effects of treatment, if all people adhered to treatment, people treated with CagriSema 2.4 mg/2.4 mg achieved a weight loss of 23.0% after 84 weeks compared to 25.5% with tirzepatide 15 mg. When applying the treatment-regimen estimand, people treated with CagriSema 2.4 mg/2.4 mg achieved a weight loss of 20.2% compared to 23.6% with tirzepatide at 84 weeks. 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.

“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. Based on the learnings from completed studies we look forward to the REDEFINE 11 readout, and the initiation of the higher-dose CagriSema trial, which are both designed to assess the full weight-loss potential of CagriSema”, said Martin Holst Lange, executive vice president, R&D and chief scientific officer at Novo Nordisk. “The results in the REDEFINE programme reinforce our commitment to transforming obesity care, through novel products such as CagriSema and zenagamtide with the potential to offer even greater health benefits for patients living with obesity.”

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Related Topics and Keywords

Novo Nordisk, obesity, REDEFINE 4 trial