• Mounjaro® delivered superior A1C reductions versus all comparators in phase 3 SURPASS clinical trials3-9
• Mounjaro®, a once-weekly injection is a prescription medicine and should be used under medical advice

New Delhi, March 20, 2025: Eli Lilly and Company (India) today announced the launch of Mounjaro® in single-dose vial presentation following the marketing authorization from the Central Drugs Standard Control Organization (CDSCO). It is a first-of-its-kind treatment for obesity, overweight, and type 2 diabetes that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) hormone receptors.

Mounjaro® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in 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. Mounjaro® is also indicated as an adjunct to diet and exercise to improve glycemic 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 was evaluated in two robust global clinical development programs: the SURMOUNT - 1 trials for chronic weight management and the SURPASS trials for type 2 diabetes.

In SURMOUNT-1, a study in 2,539 adults with obesity, or excess weight and weight-related medical problems not including diabetes, people taking Mounjaro® as an adjunct to diet and exercise experienced substantial weight loss compared with placebo at 72 weeks. At the highest dose (15 mg), people taking Mounjaro® lost on average 21.8 kg, while at the lowest dose (5 mg), people lost on average 15.4 kg (compared to 3.2 kg on placebo).1,2 Additionally, 1 in 3 patients taking Mounjaro® at the highest dose lost over 26.3 kg (25% of body weight), compared to 1.5% on placebo, according to data not controlled for type 1 error.1,2 In summary, Mounjaro® significantly reduced weight by up to 21.8 kg in the SURMOUNT-1 study.1,2

In phase 3 SURPASS program, efficacy was evaluated for Mounjaro® 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro® 5 mg and between 1.7% and 2.4% for both Mounjaro® 10 mg and Mounjaro® 15 mg over the period of 40 weeks.3-6 Overall, the program demonstrated that Mounjaro®, whether used alone or with other diabetes medications, reduced A1C by up to 2.4%.3-6

India has about 101 million people living with diabetes and nearly half of these in the adult patients category are being inadequately treated with suboptimal glycemic control.10 Obesity, a chronic relapsing disease, is a major risk factor for diabetes, is linked to over 200 health complications, including hypertension, dyslipidemia, coronary heart disease, and obstructive sleep apnea.11,12 As of 2023, adult obesity prevalence in India stood at around 6.5%, affecting nearly 100 million people.13

“Obesity and diabetes are recognized 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.

Once-a-weekly, prescription-based medicine, Mounjaro® is a single molecule that selectively binds to and activates both GIP and GLP-1 receptors, which are natural incretin hormones. In a glucose-dependent manner, Mounjaro® improves first phase and second phase insulin secretion, and reduces glucagon levels; it also improves insulin sensitivity and delays gastric emptying14. GIP receptors and GLP-1 receptors are both expressed in important areas of the brain that regulate appetite. Mounjaro® reduces food intake, body weight, and decreases fat mass by regulating appetite; moreover, Mounjaro® has been demonstrated to regulate lipid utilization.14 Mounjaro® (tirzepatide) has already had a tremendous impact on millions of people living with type 2 diabetes and obesity, respectively.

About Lilly

Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Home | Lilly India follow us on LinkedIn. 

References:

1. Mounjaro. Prescribing Information for India.
2. Jastreboff AM, Aronne LJ, Ahmad NN, et al; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216.
3. Rosenstock, J, et. al. Efficacy and Safety of Once Weekly Tirzepatide, a Dual GIP/GLP-1 Receptor Agonist Versus Placebo as Monotherapy in People with Type 2 Diabetes (SURPASS-1). Abstract 100-OR. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.
4. Rosenstock, J, et. al. (2021). Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. doi: 10.1016/S0140-6736(21)01324-6.
5. Frías JP, Davies MJ, Rosenstock J, et al; for the SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6) (suppl):503-515. doi: 10.1056/NEJMoa2107519
6. Frias, J.P. Efficacy and Safety of Tirzepatide vs. Semaglutide Once Weekly as Add-On Therapy to Metformin in Patients with Type 2 Diabetes. Abstract 84-LB. Presented virtually at the American Diabetes Association's 81st Scientific Sessions; June 25-29.
7. Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. doi: 10.1016/S0140-6736(21)01443-4
8. Del Prato S, Kahn SE, Pavo I, et al; for the SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. doi: 10.1016/S0140-6736(21)02188-7
9. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. doi:10.1001/jama.2022.0078
10. Metabolic non-communicable disease health report of India: the ICMR-INDIAB national cross-sectional study (ICMR-INDIAB-17) - The Lancet Diabetes & Endocrinology                                                       
11. Waters H, Graf M. America’s Obesity Crisis: The Health and Economic Costs of Excess Weight. Milken Institute; 2018. Accessed February 20, 2024. https://milkeninstitute.org/sites/default/files/reports-pdf/Mi-Americas-Obesity-Crisis-WEB_2.pdf
12. Wolk R, Shamsuzzaman AS, Somers VK. Obesity, sleep apnea, and hypertension. Hypertension. 2003;42(6):1067-1074. doi:10.1161/01.HYP.0000101686.98973.A3
13. IQVIA analysis and projection based on National Family Health Survey (NFHS-5), India, 2019-20 and Data from Global Observatory (World Obesity)- https://data.worldobesity.org/country/india-95/#data_economic-impact
14. Rosenstock J, Wysham C, Frias JP, et al. Lancet 2021; 398(10295): 143-155.