- An injection being developed by biotechnology company Viking Therapeutics for obesity helped adults enrolled in a small clinical trial lose up to 8% of their body weight, the company said Tuesday. If successful, the shot could compete with drugs from Novo Nordisk, Eli Lilly and others.
- The Phase 1 trial was designed to find the best dose to advance into larger mid- and late-stage studies that Viking would use to prove the drug works. The largest weight loss reported was among trial volunteers who receive a dose as high as 10 milligrams per week. Participants given lower doses experienced less weight loss.
- VK2735, as the injection is called, activates the same two insulin-stimulating hormones as Eli Lilly’s new diabetes drug Mounjaro, which is in the second of two Phase 3 trials before a planned application for approval as an obesity treatment. Shares in Viking rose more than 50% in morning trading Tuesday.
Novo Nordisk pioneered the use of insulin-stimulating diabetes drugs as weight loss treatments when it launched a high-dose version of its daily shot Victoza as Saxenda in 2014. It followed on that success years later with a weekly shot, marketed as Ozempic for diabetes and Wegovy for weight loss. (Ozempic is also being used off-label as a weight loss drug as demand has outstripped Novo’s supply.)
Those drugs activate only one insulin-secreting hormone, called GLP-1. Lilly’s Mounjaro stimulates a second one, dubbed GIP, and Viking — better known for development of an experimental drug for the liver disease NASH — is trying to duplicate that treatment approach.
Viking’s two-part study first enrolled adults to receive single doses of VK2735 to evaluate its safety and biologic activity, then enrolled people diagnosed as obese to take increasing weekly doses over four weeks. Ten participants also received a placebo.
Six people randomized to receive 0.5 milligrams of VK2735 during the four weeks of the trial lost 2.5% of their body weight, compared with 1.8% in the placebo arm, a difference that was not statistically significant. By comparison, the six patients given 5 milligram weekly dose and later 10 milligrams experienced a 7.8% lowering in body weight, which was considered a statistically significant difference versus placebo.
Side effects of the experimental drug included mild and moderate nausea, a common complaint of this class of drugs, but no one stopped treatment because of this side effect. One participant with a history of gallstones experienced a case of gall bladder obstruction, Viking said.
In testing its GLP-1/GIP drug, Viking avoided the fate of another company called Altimmune, which last week reported high dropout rates due to side effects in a trial of a similar weight loss drug.
In a statement, Viking said the side effect data suggests it could increase doses higher with a longer build-up period, an approach the company may try in a Phase 2 trial.
Viking also announced Tuesday that it is planning to begin a Phase 1 trial of an oral version of VK2735.