A view of the logo of Novo Nordisk at the company’s office in Bagsvaerd, on the outskirts of Copenhagen, Denmark, March 8, 2024.
Tom Little | Reuters
Copenhagen, DENMARK — Novo Nordisk defended disappointing trial results for its much-hyped next generation obesity drug candidate CagriSema, insisting it will be an “important” weight loss treatment.
CEO Lars Fruergaard Jørgensen on Thursday acknowledged the sharp share price reaction after two consecutive late-stage trials showed underwhelming weight reduction versus the company’s own targets, but said he nevertheless remained “encouraged” by the drug’s weight loss profile.
“I’m very confident about CagriSema,” he told shareholders at the firm’s Annual General Meeting in Copenhagen, Denmark.
“It will be an important product for us.”
CagriSema is a combination of cagrilintide — a nascent form of weight loss treatment known as an amylin analog — and semaglutide, the active ingredient in Wegovy.
Headline results from a REDEFINE-2 late-stage trial released earlier this month showed that CagriSema helped obese or overweight adult patients with type 2 diabetes lose 15.7% of their weight over 68 weeks, compared with 3.1% with placebo. This was below the high-teens percentage of weigh loss previously forecast.
A prior late-stage trial published in December showed the drug helped obese or overweight patients with one or more comorbidities, but not type-2 diabetes, lower their weight by 22.7% after 68 weeks, also below the 25% expected.
Both results wiped significant value from Novo’s share price as investors’ hopes of finding a superior alternative to the company’s existing Wegovy injection and rival Eli Lily’s Zepbound, both GLP-1 medications, were dashed. The once darling stock is now down more than 50% from its 2024 highs.
Novo Nordisk
The Danish pharmaceutical giant faced pushback once again Thursday, as shareholders urged the board for clearer and tactically sound trials and targets in a bid to provoke less dramatic share price moves.
Fruergaard Jørgensen acknowledged the criticism, particularly around the firm’s failure to accurately communicate the flexible trial design, which raised questions over tolerability, with fewer than two-thirds of patients progressing to the highest dose after 68 weeks.
“22.7% is not 25%, so some people were disappointed about that,” he said, however adding that the firm believes there is “continued potential for developing CagriSema further,” including by extending the trial period and overall dosage.
Novo Nordisk is now conducting a new Phase 3 trial, dubbed REDEFINE 11, which will “further explore the potential of CagriSema,” the CEO said.
It comes as the weight-loss industry remains divided over the broader applications and outcomes of obesity drugs beyond total weight reduction. In a note earlier this month, BofA Global Research said it had grown “slightly more cautious on differentiation” in obesity and diabetes treatment following CagriSema’s latest results.
However, Soren Lontoft, pharma equity analyst at Sydbank, told last week that there was need for a diverse range of treatments to address both obesity and tolerability levels, as well as associated health risks like cardiovascular disease, sleep apnea and liver disease.
“It’s clear that there is a very large market opportunity but it also takes a portfolio of products that cater for different patient needs,” Fruergaard Jørgensen noted.
