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Eli Lilly has received fast track designation from the US Food and Drug Administration (FDA) for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities, the company announced.

Lilly also outlined its plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based predominantly on results from two phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023.

Under the rolling review, Lilly will be able to submit parts of its application to the FDA as they finish out rather than waiting until all sections are completed, with the company adding that it hopes to complete the submission shortly after SURMOUNT-2 data is available.

In the phase 3 SURMOUNT-1 trial, tirzepatide met both of its primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo.

Crucially, the overall safety and tolerability profile of tirzepatide was similar to other incretin-based therapies approved for the treatment of obesity.

The decision comes as obesity continues to be a major health concern in the US, with the disease estimated to have affected more than 40% of the population and cost nearly $173bn annually. Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, and are among the leading causes of preventable, premature death, according to federal data.

Mike Mason, president, Lilly Diabetes, said: “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of healthcare costs. While diet and exercise are important steps, most patients don’t achieve their desired treatment goals with only diet and exercise.

“We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide, which produced significant weight reductions in patients taking tirzepatide for type 2 diabetes in SURPASS. Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20% in SURMOUNT-1.”

Tirzepatide was approved as Mounjaro by the FDA in May 2022 to improve glycemic control in adults with type 2 diabetes mellitus.