Lilly Korea announced on the 1st that its GIP/GLP-1 dual-acting agent, Mounjaro (tirzepatide), has received approval from the Ministry of Food and Drug Safety (MFDS) as an adjunct for chronic weight management.

Mounjaro is the first and, to date, the only (as of July 2024) GIP/GLP-1 dual receptor agonist available. It selectively binds to and activates both GIP and GLP-1 receptors, the targets of endogenous GIP and GLP-1, to lower fasting and postprandial blood glucose concentrations and reduce body weight and body fat.

GIP and GLP-1 are two primary incretin hormones that stimulate insulin secretion, improve insulin sensitivity, reduce glucagon secretion, regulate appetite, and maintain satiety.

The approval authorizes the use of Mounjaro as a once-weekly subcutaneous injection as an adjunct to a reduced-calorie diet and exercise regimen for chronic weight management in adult patients.

It is indicated for ▲ obese adult patients with an initial body mass index (BMI) of 30kg/m² or greater, or ▲overweight patients with an initial BMI of 27kg/m² or greater but less than 30kg/m² with one or more weight-related comorbidities (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, or cardiovascular disease).

In June 2023, Mounjaro was first approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The approval was based on the Phase III SURMOUNT-1 and SURMOUNT-2 clinical trials.

SURMOUNT-1 was a 72-week study that evaluated the efficacy and safety of Mounjaro in 2,539 adults with obesity (BMI≥30 kg/m²) or overweight (27kg/m²≤BMI<30kg/m²) with one or more weight-related comorbidities (dyslipidemia, hypertension, obstructive sleep apnea, or cardiovascular disease) other than type 2 diabetes.

SURMOUNT-2 was a 72-week study of 938 adult patients with a BMI of 27kg/m² with type 2 diabetes. The primary endpoints of both studies were mean percent change in body weight from baseline to week 72 and percent achievement of weight reduction ≥5%.

Results showed that Mounjaro achieved statistically significant weight loss compared to placebo in all strengths, and the rate of weight loss of 5% or more was higher in the Mounjaro group than in the placebo group.

"Obesity is a chronic disease that affects approximately 17 million adults in Korea. It increases the risk of more than 200 complications, including type 2 diabetes and cardiovascular disease," said Cheol-Young Park, Chairman of the Korean Society for the Study of Obesity (Department of Endocrinology, Kangbuk Samsung Medical Center). "As new anti-obesity drugs with new mechanisms of action are being developed, we hope that the introduction of the new drugs will serve as an opportunity to more actively consider various medical interventions, including drug treatment, for severely obese patients who face the limitations of weight management despite lifestyle interventions."

“Starting with Mounjaro’s indication expansion in Korea, Lilly will continue its best efforts to improve the misconceptions about obesity in society to create a treatment environment where obese patients can receive timely diagnosis and evidence-based obesity management," said Kye Won Kim, Executive Director of Diabetes Business Unit & CMO at Lilly Korea.