Early analysis from a phase 3 REDEFINE 1 trial showed the once-weekly Cagrilintide monotherapy injection helped patients reduce their weight by 11.8% on average after 68 weeks, compared to 2.3% for those on placebo, the company said.
Cagrilintide is a nascent form of weight loss treatment which differs existing GLP-1s, such as Novo Nordisk”s Wegovy and Eli Lilly’s Zepbound. The long-acting amylin analogue which works by mimicking a hormone that is co-secreted with insulin in the pancreas to increase satiety.
The drug maker also pointed to the treatment’s increased tolerability profile, describing it as “well-tolerated” with the most common side effects being gastrointestinal and mainly “mild to moderate.”
Shares of Novo Nordisk were up 1.3% by 11:15 a.m. London time, shortly after the findings were released.
“In our clinical trials, Cagrilintide has provided substantial weight loss, in a distinct manner compared to approved obesity medications, and appears well-tolerated,” Martin Holst Lange, Novo Nordisk’s chief scientific officer and executive vice president of research and development, said in a statement.
“We’re excited that these data, the first phase 3 data of a next-generation amylin therapy, show promise and we look forward to further investigating Cagrilintide’s potential in the dedicated phase 3 RENEW programme,” Lange added.
Novo Nordisk is seeking a next-generation obesity treatment after the runaway success of its Ozempic diabetes and Wegovy obesity treatments have lately come under pressure from supply constraints and increased competition from copycat compounded drug makers.
Drug makers are also seeking alternative treatments for patients who struggle to remain on GLP-1s long term. Roche and Zealand Pharma are also developing an amylin analogue obesity treatment known as Petrelintide.
Investors were previously disappointed by late-stage trial results for CagriSema, a combination therapy which combines Semaglutide, the active ingredient in Wegovy, along with Cagrilintide.
However, Soren Lontoft, pharma equity analyst at Sydbank, told CNBC that the side-effect profile was perhaps the most promising aspect of the new treatment.
“The side effect profile for Cagrilintide is of more interest than the weight loss. A more favourable side effect profile (with low discontinuation rate) than Wegovy and Zepbound is what I’m looking for,” Lontoft said by email on Tuesday.
The sub-analysis trial results, which were presented at the European Association for the Study of Diabetes congress in Vienna, Austria, evaluated adult patients with obesity or overweight and a weight-related comorbidity without diabetes.
A dedicated phase 3 RENEW trial — which investigates the efficacy and safety of the drug in patients with obesity or who were overweight, but without associated comorbidities — is scheduled to start in late 2025.
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