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In 2017, the Olympics burst onto the scene Approval For type 2 diabetes, drugmakers Novo Nordisk and Eli Lilly have been battling to leapfrog each other with new and effective drugs that turbo-charge diabetes and weight loss results from a class known as GLP-1 receptor agonists.
Novo Nordisk's latest weight-loss trial, a combination drug called CagriSema, matched the bar set by Lilly's currently approved drug Zipbond, but failed to beat it cleanly in late-stage clinical trial findings. reported Friday.
Novo Nordisk is calling CagriSema by combining the experimental drug semaglutide, an ingredient found in Ozpic, and the weight-loss drug Wegovy, with a drug called cagrilintide.
The 68-week study showed that participants on CagriSema lost 23% of their body weight, compared to 12% for those taking cagrilintide alone, 16% for those on semaglutide and 2.3% for those on placebo.
That said, the study met its primary goal, but those who closely follow the weight loss drug competition have given up their hopes for the average effect of Cagrisema, at least a 25% weight loss. with GLP-1 drugs.
Lilly's Zepbound, the Indiana-based drug giant's response to Novo Nordisk's Wegovi, was approved in November 2023; He showed. After 72 weeks, an average weight loss of 21% was observed for the highest dose in a Phase 3 trial and another trial of Lilly's drug, retatrutide, in the middle phase. He showed. 24% weight loss after 48 weeks.
“We are encouraged by CagriSema's weight loss profile showing superiority over semaglutide and cagrilintide in monotherapy,” said Martin Holst Lange, executive vice president of development at Novo Nordisk, in a company news release Friday. Novo Nordisk said it will use insights from the trial to “further investigate CagriSema's additional weight loss potential.”
Shares of Novo Nordisk fell 19% early Friday on the news, wiping tens of billions of dollars off the value of the Danish pharmaceutical giant.
The side effects of CagriSema are similar to other drugs in the GLP-1 class. The company said the most common are gastric ulcers, “most” of which are mild to moderate and go away over time. Just over half of the participants made it up to the maximum dose, leading some to question whether the compound could be intolerable at higher doses.
Novo Nordisk said it expects results from the second Phase 3 trial in the first half of 2025.
The study, which Novo Nordisk calls REDEFINE 1, is the same group approved for weight loss in people who are overweight or obese and have at least one medical condition, the study reported Friday. Participants' average body weight at baseline was 106.9 kilograms, or about 236 pounds.
Novo Nordisk's Ozympic and Wegovi are based on a substance called semaglutide, which mimics a hormone known as GLP-1, which is important for insulin secretion, digestion and appetite. Wegovi was approved by the FDA in 2021, helping people lose an average of 15% of their body weight in 68-weeks. Clinical trial.
Lilly responded with Mounjaro and Zepbound, approved for diabetes and weight loss in 2022 and 2023, respectively. To copy the effect, they use not only GLP-1, but another hormone called tirzepatide.
Head-to-head sponsored by Lily Experiment Earlier in December, he consolidated the findings from various studies, and Zepbon caused more weight loss in 72 weeks on average than Wegovy – 20% compared to 14%.
“Some people have described it as an arms race between Lilly and Novo,” he said Dr. Daniel SkowronskiLilly's chief science officer in a November interview with . “I don't like those words, because it's a health competition; we're motivated by competition to make better and better drugs for the benefit of patients.”
The competition has also benefited drugmakers and their investors. Lilly's market cap now exceeds $700 billion, with GLP-1 drugs raking in billions of dollars in annual revenue, a quintupling over the past five years. During that time, Novo Nordisk's stock has tripled to more than $300 billion.
Experts suggest that the field is moving at an alarming rate.
“I still remember when it was 5%. [weight loss] It was our goal and we will be happy with it Dr. Eduardo GranvaldCagrisema, medical director of the Center for Advanced Weight Management at the UCSD Bariatric and Metabolic Institute, said in an interview with before the release of the results.
Previous weight-loss drugs such as Qsymia, a combination of older non-GLP-1 drugs, and liraglutide, formerly sold under the brand name GLP-1. SaxendaIt produced an average weight loss of 8 to 11 percent, according to the Yale School of Medicine. Dr. Jorge Moreno.
“It will be the expectation for patients with these old drugs to improve Their cholesterol, their blood glucose numbers or their blood pressure,” Moreno told in an email this week. “Semaglutide has achieved average weight loss [about] 15% game-changing by 2021, he said, increasing clinical benefit from “improvement to Atonement Other diseases such as hypertension, hyperlipidemia and diabetes.
Moreno and Grunwald claim that a 25% weight loss results from bariatric surgery. And in Novo Nordisk's CagriSema trial, 40% of participants lost at least 25% of their body weight – not enough to skew the trial's overall average results beyond that measure.
“Five years ago, you would have said, 'Novo Nordisk is going to launch a new drug. [where] 40% of people lose 25% of the weight, but that's really sad in 2024.' Dr. Daniel DruckerA pioneer of research on GLP-1 at the University of Toronto, he has worked with companies developing these drugs.
how much weight do you lose Drucker told Friday that GLP-1 drugs have shown health benefits in studies. Metabolic liver disease And Sleep apnea And Osteoarthritis And Heart disease And Stroke”, “Doesn't seem to depend on weight loss.
Although next-generation drugs have shown high levels of weight loss, Drucker said, trials will take several years to confirm other results that are more meaningful to patients and doctors.
With CagriSema, Novo Nordisk is targeting an additional hormone, amylin, in addition to GLP-1. Lilly's Retatrutide builds on Trizepatide's GLP-1 and GIP by increasing another hormone target, Glucagon – giving it a “Triple G” signal.
Another drug company, Amgen, took a different approach, blocking GIP as tirzepatide does rather than activating it. The drug, called Maritide, produced an average of 20% weight loss in a one-year trial Results It was reported in November.
The drug is designed to be given less frequently than Wegovy and Zepbound — with injections once a month or less, compared to the current drug's weekly injections. Still, the results prompted investors to sell off Amgen's stock, fearing it won't be able to catch up with competitors.
“It shows you how fast the field is moving and how expectations are moving,” Drucker said.
“There is some evidence to suggest that amylin activation may have less muscle-mass loss, so I was looking forward to seeing the data on the effect of Cargsema on body composition, muscle and fat,” Grunwald said. In its news release on Friday, Novo Nordisk reported only the top-line results of the study. Typically, companies publish complete results later in a peer-reviewed medical journal.
The signal that targeting amylin preserves weight during weight loss — a key question about GLP-1 drugs — has so far come from animal studies, Drucker noted, leading him to question whether the results would hold up in human studies.
But another hormone called glucagon, a third additive in Lilly's retatrutide, is “very good at removing fat from the liver,” so it may be especially beneficial for people with metabolic liver disease, he said.
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“The next most important chapter in the story, after the weight loss, is, 'OK, what is the unique characteristic of each of these partners, and does this provide a unique benefit?' It would mean,” Drucker said.
But he said it's also important to know if it affects safety.
“GLP-1 drugs alone have a very strong safety record,” Drucker said, “but every time we add something, we start over.
And targeting just one hormone, GLP-1, also made a difference.
“For years, we thought it was always just a craving, like when someone is overweight and can't stop eating,” he says. Dr. Clayton RunfaloPracticing family medicine at Ochsner Health in Louisiana.
A better understanding of these hormones over the past few decades has changed that, Runfalo says. Now he sees GLP-1 drugs as a tool for behavior modification that is “very good for us as far as helping people get healthy.”