A large trial showed that a high dose of Eli Lilly and Co's (LLY.N) Mounjaro helped people with type 2 diabetes who were also obese or overweight to lose nearly 16% of their body weight, or over 34 pounds (15kg) on average, the company said on Thursday.
The degree of mean weight reduction seen in the latest trial "has not been previously achieved in phase 3 trials for obesity or overweight and type 2 diabetes," Jeff Emmick, Lilly senior vice president, product development, said in a statement.
Lilly said over 86% of people taking the 15 mg dose of the injected drug achieved at least 5% weight loss, compared with 30.5% of placebo patients.
Trial participants given a lower 10 mg dose of Mounjaro, also known as tirzepatide, achieved average weight loss of over 13%, or about 30 pounds (14kg), and nearly 82% lost at least 5% of their body weight.
Based on results from the 72-week study, which enrolled 938 adults, Lilly said it plans to complete a submission to the U.S. Food and Drug Administration seeking approval for use of Mounjaro as a treatment for adults with obesity or overweight. "We expect regulatory action as early as late 2023," it said.
Jefferies analyst Akash Tewari estimated in a March research note that the trial could show placebo-adjusted weight loss of around 15% for the higher dose of Mounjaro.
Lilly's medication, part of a new class known as incretins, is already approved for treating diabetes. The new drugs, which include Novo Nordisk's (NOVOb.CO) Ozempic and Wegovy, are designed to activate hormones that regulate blood sugar, slow stomach emptying and decrease appetite.
