Novo Nordisk's CagriSema Outperforms Ozempic in Phase 3 Diabetes Trial

Novo Nordisk's investigational dual agonist CagriSema demonstrated superior efficacy to Ozempic in a phase 3 trial for type 2 diabetes patients, while the company faces market share losses to Eli Lilly in the GLP-1 space.

Novo Nordisk recently shared data from a late-stage study with CagriSema, in which it went head-to-head against Ozempic in type 2 diabetes patients who were also overweight or obese. In the trial, CagriSema led to an average 1.91% reduction in blood sugar from a baseline of 8.2%. It also led to an average weight loss of 14.2%. CagriSema beat Ozempic in this study.

CagriSema is a dual agonist, meaning it mimics the actions of two different gut hormones: GLP-1 and amylin, both of which help regulate blood sugar and satiety. In late 2024, Novo Nordisk announced that CagriSema performed better than semaglutide (the active ingredient in the brands Wegovy for weight loss and Ozempic for diabetes) in a phase 3 weight-loss clinical trial in patients who were overweight or obese but who didn't have type 2 diabetes. The next-gen GLP-1 therapy led to a mean weight reduction of 22.7% after 68 weeks, compared with 16.1% with Wegovy.

Novo Nordisk has already submitted regulatory applications for CagriSema as a weight loss treatment. It will seek regulatory approval for the diabetes medicine after completing two other phase 3 studies, including one focused on cardiovascular outcomes.

Despite CagriSema's strong performance, it will be more complex to manufacture (and more expensive) than semaglutide, which has run into supply constraints several times. Also, CagriSema still doesn't seem to match the efficacy of Eli Lilly's retatrutide, which posted a mean weight loss of up to 28.7% in a phase 3 study.

The Denmark-based drugmaker has lost ground to its biggest competitor, Eli Lilly, in the GLP-1 market. In the U.S., Lilly took leadership a year ago and has progressively increased its market share. Lilly now holds 60% of the market, while Novo's share has fallen to 39%.

Lilly makes tirzepatide, marketed as Mounjaro for type 2 diabetes and as Zepbound for weight loss. These drugs entered the market later than Novo's, but they've taken the lead. Lilly reported triple-digit revenue growth for Mounjaro and for Zepbound in the recent quarter, and together these drugs brought in more than $11 billion in revenue.

Lilly ran a head-to-head study of Zepbound versus Wegovy, and it showed that the Lilly drug helped people lose more weight. The company has done a great job of ramping up its manufacturing, making doses of its product readily available for patients. This is key because both semaglutide and tirzepatide were in shortage a couple of years ago.

Though Novo recently launched a Wegovy pill -- the other commercialized GLP-1s are injectables -- Lilly could be set for a win in this space too. The company's oral weight loss candidate is under regulatory review right now, and unlike the Wegovy pill, it doesn't involve dietary restrictions.

Novo Nordisk's current lineup will lead to declining sales this year, according to the company's guidance. However, Novo Nordisk has several promising diabetes and weight products in development, including Amycretin, in both oral and subcutaneous formulations. Wegovy has recently earned important label expansions, including for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), which will help boost its sales.

Though Ozempic, made by Novo Nordisk, is approved for type 2 diabetes, the drug has also been prescribed for weight loss. It's part of the popular GLP-1 class of drugs. Novo was first to market with a GLP-1 drug in 2017 and maintained leadership for a while. GLP-1 drugs work by interacting with hormonal pathways involved in digestion, and by doing this, they help regulate a person's blood sugar levels -- and control appetite. As a result, they've helped those suffering from diabetes and aiming to lose weight. Regulators have approved Novo's semaglutide for type 2 diabetes as Ozempic and for obesity as Wegovy.

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References

  1. Forget Ozempic: This Obesity‑ Drug Giant Is Grabbing the Biggest Slice of the GLP‑1 Gold Rush · finance.yahoo.com
  2. Novo Nordisk faces copy competition in India: Dr. Reddy's set to launch Wegovy imitation · medwatch.com
  3. Novo Nordisk's New Diabetes Drug Outshines Ozempic: Is The Stock a Buy? · www.fool.com
  4. Novo Nordisk's New Diabetes Drug Outshines Ozempic: Is The Stock a Buy? - Yahoo Finance · finance.yahoo.com
  5. Novo Nordisk's New Diabetes Drug Outshines Ozempic: Is The Stock a Buy? · www.theglobeandmail.com