Eli Lilly and Company (India) on Thursday announced the launch of its globally popular weight-loss injectable drug, Mounjaro, in India. Adults taking the drug with diet and exercise in a controlled clinical trial lost on average 21.8kg at the highest dose and 15.4kg at the lowest dose over a period of 72 weeks, said the company.
The single-dose vial presentation has marketing authorization from the national drugs regulator—Central Drugs Standard Control Organization (CDSCO). The drug is already widely popular in US, UK and European markets.
According to the company statement, 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.
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 utilisation. Mounjaro (tirzepatide) has already had a tremendous impact on millions of people living with type 2 diabetes and obesity, respectively.
“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,” read the company statement.
Chemically known as Tirzepatide, the drug 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.
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According to the data shared by the company, 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).
“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… In summary, Mounjaro significantly reduced weight by up to 21.8 kg in the SURMOUNT-1 study.”
In phase 3 SURPASS programme, said the company, efficacy was evaluated for Mounjaro 5mg, 10mg and 15mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas and insulin glargine.
Participants in the SURPASS programme 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. Overall, the program demonstrated that Mounjaro, whether used alone or with other diabetes medications, reduced A1C by up to 2.4%.
India has about 101 million people living with diabetes and nearly half of these in the adult patients category is being inadequately treated with suboptimal glycemic control. Obesity, a chronic relapsing disease, is a major risk factor for diabetes, and is linked to over 200 health complications, including hypertension, dyslipidemia, coronary heart disease, and obstructive sleep apnea. Per various estimates, as of 2023, adult obesity prevalence in India stood at around 6.5%, affecting nearly 100 million people.
“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.