The pharmaceutical company Lilly has announced that the European Commission (EC) has granted marketing authorization for MounjaroTM (tirzepatide) in adults with obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/m2 to <30 kg/m2 ) and who present at least one comorbidity related to excess weight. In Europe this drug was only approved until now for the treatment of type 2 diabetes.
Last November, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion on the drug and had recommended its authorization, which was based on the positive results obtained in the phase III SURMOUNT-1 trial in obese or overweight people without type 2 diabetes, but with at least one weight-related comorbidity, as well as in the results of the subgroup of patients with obesity or overweight and type 2 diabetes from the SURPASS clinical program .
“Obesity is a chronic and progressive disease that requires effective treatment options. Tirzepatide is the first and only treatment that activates both GIP and GLP-1 hormone receptors. In our SURMOUNT-1 clinical trial, tirzepatide as an adjunct to diet and exercise significantly reduced body weight and achieved an average weight loss of more than 20% after 72 weeks of treatment with doses of 10 mg and 15 mg,” explained the Dr. Miriam Rubio de Santos, medical director of the Diabetes and Obesity area at Lilly Spain.
Weight reduction since the start of treatment with tirzepatide
Mounjaro is the first weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist for weight control in adults with obesity (BMI ≥30 kg/m2). ) or overweight (BMI ≥27 kg/m2 to <30 kg/m2).
In Surmount-1, participants treated with tirzepatide as an adjunct to diet and exercise achieved mean weight reductions of 16% (16 kg at the 5 mg dose), 21.4% (22 kg at the 10 mg dose), and 22.5% (24 kg with the 15 mg dose) compared to 2.4% with placebo (2.4%, 2 kg). Additionally, 89% (5 mg) and 96% (10 mg and 15 mg) of people receiving tirzepatide achieved body weight reductions of at least 5%, compared with 28% of those in the placebo group .
“Tirzepatide as an adjunct to diet and exercise significantly reduced body weight and achieved an average weight loss of more than 20% after 72 weeks of treatment with doses of 10 mg and 15 mg”
Both SURMOUNT-1 and Surpass demonstrated that the use of tirzepatide resulted in a reduction in body weight from baseline. Regarding the side effects of the treatment, gastrointestinal adverse reactions were mostly mild (63%) or moderate (32.6%). The incidence of nausea, vomiting, and diarrhea was highest during the dose escalation period and decreased over time.
