Eli Lilly launches Mounjaro in India for obesity and type 2 diabetes

Eli Lilly and Company (India) has announced the launch of Mounjaro (tirzepatide) in a single-dose vial presentation following marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO). Mounjaro is a dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated for chronic weight management and glycaemic control in adults.

Mounjaro is approved as an adjunct to a reduced-calorie diet and increased physical activity for adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity) or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition. It is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus.

“The dual burden of obesity and type 2 diabetes is rapidly emerging as a major public health challenge in India. Lilly is committed to collaborating with the government and industry to promote awareness and improve the prevention and management of these diseases,” said Winselow Tucker, President and General Manager, Lilly India. “Our mission to making life better for people living with obesity and diabetes in India is reflected in our efforts to accelerate the introduction of innovative medicines. The launch of Mounjaro demonstrates our ongoing support to this mission and our shared vision of a healthier nation.”

Tirzepatide has been evaluated in two global clinical development programmes: the SURMOUNT-1 trial for chronic weight management and the SURPASS programme for type 2 diabetes.

The SURMOUNT-1 study included 2,539 adults with obesity or overweight with weight-related medical conditions, excluding diabetes. Participants receiving Mounjaro alongside diet and exercise experienced significant weight loss compared with placebo at 72 weeks. Those on the highest dose (15 mg) lost an average of 21.8 kg, while those on the lowest dose (5 mg) lost an average of 15.4 kg, compared to 3.2 kg on placebo. Additionally, 1 in 3 patients on the highest dose lost over 26.3 kg (25 per cent of body weight), compared to 1.5 per cent on placebo.

The SURPASS programme evaluated the efficacy of Mounjaro in doses of 5 mg, 10 mg, and 15 mg, used alone or in combination with commonly prescribed diabetes medications such as metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine. Over 40 weeks, participants achieved A1C reductions between 1.8 per cent and 2.1 per cent for Mounjaro 5 mg, and between 1.7 per cent and 2.4 per cent for both Mounjaro 10 mg and Mounjaro 15 mg.

India has approximately 101 million people living with diabetes, with nearly half of the adult population experiencing suboptimal glycaemic control. Obesity is a major risk factor for diabetes and is associated with over 200 health complications, including hypertension, dyslipidaemia, coronary heart disease, and obstructive sleep apnoea. As of 2023, adult obesity prevalence in India was approximately 6.5 per cent, affecting nearly 100 million people.

“Obesity and diabetes are recognised as serious conditions linked to various life-limiting health complications, making effective and sustained treatment critical. We are thrilled to introduce Mounjaro in India to address these unmet medical needs. Mounjaro may offer a new approach to metabolic health management, providing healthcare providers with an innovative option to treat these diseases,” said Dr Manish Mistry, Senior Medical Director, Lilly India.

Mounjaro is a once-weekly, prescription-based treatment that selectively binds to and activates both GIP and GLP-1 receptors. In a glucose-dependent manner, it improves first- and second-phase insulin secretion, reduces glucagon levels, improves insulin sensitivity, and delays gastric emptying. GIP and GLP-1 receptors are present in brain regions that regulate appetite. Mounjaro reduces food intake, body weight, and fat mass by modulating appetite and lipid utilisation.

Mounjaro (tirzepatide) has already been introduced in global markets for the treatment of type 2 diabetes and obesity.