A Novo Nordisk drug candidate for type 2 diabetes beat Eli Lilly’s dulaglutide (Trulicity) in reducing blood sugar and body weight in patients studied in a late-stage clinical trial, the Denmark-based company says. The results could bring strong competition to one of Indianapolis-based Lilly’s top-selling products if Novo Nordisk’s experimental drug is approved by the FDA and other global regulatory agencies.
Like Lilly’s (NYSE: LLY) dulaglutide, Novo Nordisk’s semaglutide is a once-a-week injectable treatment. Both are glucagon-like peptide-1 (GLP-1) therapies, a class of drugs that stimulate insulin and suppress glucagon, the two hormones that work together to regulate blood sugar.
In a 40-week Phase 3 trial that enrolled 1,201 patients, Novo Nordisk tested its drug at two doses in combination with metformin, a first-line treatment for diabetes. The main goal of the trial was measuring a reduction in hemoglobin A1c, an indicator of blood sugar levels. At the 0.5 mg dose, the Novo Nordisk drug reduced hemoglobin A1c by 1.5 percent from baseline compared to 1.1 percent by 0.75 mg dulaglutide. At the 1.0 mg dose of Novo Nordisk’s drug, the reduction was 1.8 percent compared to 1.4 percent with 1.5 mg dulaglutide.
As for body weight, patients given the 0.5 mg of Novo Nordisk’s semaglutide lost an average of 10.1 pounds compared to 5 pounds with 0.75 mg of dulaglutide. At the higher dose, the average weight loss in patients taking the Novo Nordisk drug was 14.33 pounds, compared to 6.6 pounds for patients given dulaglutide.
GLP-1 drugs have been linked to possible higher risks of pancreatitis and cancer. In its Phase 3 trial, Novo Nordisk reported that the most common adverse events were mild to moderate nausea, comparable to dulaglutide. Novo Nordisk said that the nausea diminished over time. Four patients in the semaglutide group reported diabetic retinopathy—damage to the retina that can lead to blindness— compared to five in the dulaglutide group.
The FDA approved dulaglutide in 2014. Last year, Lilly reported that the drug accounted for $925 million in revenue. In an attempt to strengthen the case for its drug, Lilly has been testing dulaglutide in another study to assess its ability reduce cardiovascular problems in patients who have type 2 diabetes. In a research note, Leerink Partners analyst Seamus Fernandez wrote that dulaglutide’s sales should continue growing in the short term. But if semaglutide is approved, Fernandez expects the Lilly drug will eventually lose market share due to the blood sugar and weight reduction advantages of the Novo Nordisk drug.
The advantages of Novo Nordisk’s semaglutide will become bigger selling points if Lilly’s drug fails to show additional cardiovascular benefit, Fernandez noted. Lilly expects to report results from the cardiovascular study in the second half of next year. But Lilly isn’t placing all of its bets on dulaglutide. Earlier this year, the company paid $55 million up front for rights to compounds developed by KeyBioscience, a Denmark-based biotech company. Lilly said at the time that the KeyBioscience compounds, from a potentially new class of drugs, could treat diabetes in ways that are different than Lilly’s current lineup of products.