First Chinese Evidence of Tirzepatide in Obesity Treatment Unveiled at EASD 2023-VCBeat

SURMOUNT-CN Phase III Clinical Study Results Showed that at Week 52, Obese and Overweight Chinese Adult Patients Treated with Tirzepatide Achieved a Maximum Weight Loss of 19.9% from Baseline
The proportion of subjects in the Tirzepatide 15 mg group achieving ≥5% weight loss (one of the co-primary endpoints) reached 92.7%.

On October 3, 2023, Eli Lilly and Company announced new research data on Tirzepatide at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD). The results showed that Tirzepatide (10 mg, 15 mg) met the co-primary endpoints and all key secondary endpoints, achieving significant and clinically meaningful weight loss in Chinese adults with obesity and overweight. This study further provides strong evidence supporting the efficacy and safety of Tirzepatide for long-term weight management in adult patients with obesity and overweight.

Statement:

1. Tirzepatide is an investigational drug and has not been approved in China.

2. Eli Lilly does not recommend the use of any unapproved drugs/indications.

SURMOUNT-CN Phase III Clinical Trial Results¹Disclosed on October 3 at EASD in a brief oral discussion format.

SURMOUNT-CN is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical trial that enrolled obese participants (BMI≥28 kg/m²).²) or overweight (BMI≥24 kg/m²) accompanied by at least one comorbidity²) in Chinese adult subjects, aiming to compare the efficacy and safety of Tirzepatide versus placebo in weight loss on the basis of a low-calorie diet and increased exercise. The study enrolled 210 Chinese patients, who were randomly assigned in a 1:1:1 ratio to receive either Tirzepatide 10 mg, 15 mg, or placebo once weekly. The co-primary endpoints were the superiority of Tirzepatide (10 mg and/or 15 mg) over placebo in terms of percentage change in body weight and the proportion of patients achieving ≥5% weight loss at 52 weeks.

At baseline, the average weight of the subjects was 91.8kg, and the average BMI was 32.3kg/m².², with an average waist circumference of 104.8 cm. The research results show,

At Week 52, the mean body weight reductions from baseline were 14.4% and 19.9% for the Tirzepatide 10mg and 15mg groups, respectively, both significantly superior to the placebo group (2.4% reduction).
The proportion of subjects achieving ≥5% weight loss in the Tirzepatide 10mg group and 15mg group was 91.4% and 92.7%, respectively, superior to the placebo group (29.4%).
At 52 weeks, the mean waist circumference reduction from baseline was 11.9 cm for the Tirzepatide 10mg group and 16.4 cm for the 15mg group, superior to placebo (2.7 cm reduction).

In the SURMOUNT-CN trial, the overall safety profile of Tirzepatide was consistent with that reported in previous trials, with no new safety signals identified. The most commonly reported adverse events during treatment in the Tirzepatide group were gastrointestinal adverse events, which were mostly mild to moderate in severity and primarily occurred during the dose-escalation period.

About the SURMOUNT Series of Clinical Trials

The SURMOUNT series of Phase III clinical development programs for Tirzepatide in long-term weight management began at the end of 2019, recruiting over 5,000 obese or overweight patients across six clinical registration studies, including four global studies, one study in China, and one study in Japan. Among these, the baseline BMI mean range of patients enrolled in the four global studies...²36.1 kg/m²Up to 38.9 kg/m²,SURMOUNT-1 Main Results and SURMOUNT-2 Study Results Have Been Published in The New England Journal of Medicine³and The Lancet⁴In addition, the Phase IIIb clinical trial SURMOUNT-5 study is further ongoing in adult patients with obesity or overweight, aiming to compare the efficacy and safety of Tirzepatide versus semaglutide 2.4mg over a 72-week treatment period.

SURMOUNT-1 (NCT04184622) is a multicenter, randomized, double-blind, parallel, placebo-controlled study. The study enrolled adults with obesity or overweight with at least one comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) who do not have type 2 diabetes. The aim is to compare the efficacy and safety of Tirzepatide (5 mg, 10 mg, 15 mg) versus placebo in weight reduction on the basis of a low-calorie diet and increased physical activity. The study recruited 2,539 patients from the United States (including Puerto Rico), China (including Taiwan Province), Argentina, Brazil, India, Japan, Mexico, and Russia, who were randomly assigned in a 1:1:1:1 ratio to receive Tirzepatide 5 mg, 10 mg, 15 mg, or placebo. The co-primary endpoints are the superiority of Tirzepatide 10 mg and/or 15 mg compared with placebo in terms of the percentage of weight reduction from baseline and the proportion of patients achieving ≥5% weight loss at 72 weeks.³Patients who were in the prediabetic stage at baseline will continue to participate in an additional 104 weeks of treatment in the SURMOUNT-1 trial after the initial 72-week trial is completed, to evaluate the impact on body weight and the potential differences in progression to type 2 diabetes after three years of treatment with Tirzepatide.
SURMOUNT-2 (NCT04657003) is a multicenter, randomized, double-blind, parallel, placebo-controlled study designed to evaluate the efficacy and safety of Tirzepatide (10 mg and 15 mg) compared with placebo in adult patients with type 2 diabetes who are obese or overweight, based on a low-calorie diet and increased exercise. The study enrolled 938 patients from the United States (including Puerto Rico), Taiwan, China, Argentina, Brazil, India, Japan, and Russia, who were randomly assigned in a 1:1:1 ratio to receive Tirzepatide 10 mg, 15 mg, or placebo. The co-primary endpoints of the study are the superiority of Tirzepatide (10 mg and/or 15 mg) over placebo in terms of the percentage reduction in body weight from baseline at 72 weeks and the proportion of patients achieving ≥5% weight loss.⁴。
SURMOUNT-3 (NCT04657016) is a multicenter, randomized, double-blind, parallel, placebo-controlled study aimed at comparing the maximum tolerated dose in non-type 2 diabetic adult patients who are obese or overweight with at least one comorbidity after intensive lifestyle intervention.Efficacy and Safety of Tirzepatide versus Placebo in Weight Loss. The study enrolled 806 patients from the United States (including Puerto Rico), Brazil, and Argentina, who were randomly assigned in a 1:1 ratio to receive either the maximum tolerated dose of Tirzepatide (15 mg or 10 mg) or placebo. The co-primary endpoints of the study were the superiority of the maximum tolerated dose of Tirzepatide over placebo in terms of the percentage reduction in body weight from baseline at 72 weeks and the proportion of patients achieving ≥5% weight loss.
SURMOUNT-4 (NCT04660643) is a multicenter, parallel, placebo-controlled randomized withdrawal study, including a 36-week open-label lead-in period with Tirzepatide and a 52-week double-blind treatment period comparing Tirzepatide to placebo. The study aims to evaluate the efficacy and safety of the maximum tolerated dose of Tirzepatide versus placebo in reducing body weight among adults who are obese or overweight with at least one comorbidity and do not have type 2 diabetes. The study enrolled 783 patients from the United States (including Puerto Rico), Taiwan, China, Argentina, and Brazil, who were randomly assigned in a 1:1 ratio to receive either the maximum tolerated dose of Tirzepatide (15 mg or 10 mg) or placebo. The primary endpoint is the superiority of the maximum tolerated dose of Tirzepatide over placebo in terms of the percentage reduction in body weight from randomization (at Week 36) at 88 weeks.
SURMOUNT-5 (NCT05822830) is a multicenter, randomized, open-label, parallel, active-controlled Phase IIIb study designed to compare the efficacy and safety of maximum tolerated doses of Tirzepatide versus Semaglutide 2.4mg in weight reduction among non-type 2 diabetes adult patients who are either obese or overweight with at least one comorbidity. The study plans to enroll approximately 700 patients from the United States (including Puerto Rico), randomized in a 1:1 ratio to receive either the maximum tolerated dose of Tirzepatide (15 mg or 10 mg) or Semaglutide 2.4mg. The primary endpoint of this study is the superiority of the maximum tolerated dose of Tirzepatide over Semaglutide 2.4mg in terms of percentage reduction in body weight from baseline at 72 weeks.

About Tirzepatide

Tirzepatide, a once-weekly injectable GIP/GLP-1 receptor agonist, is a single-molecule peptide that binds to and activates the human body's natural incretin receptors, the GIP receptor and GLP-1 receptor. Both GIP and GLP-1 receptors are expressed in key areas of the brain that regulate appetite. Tirzepatide reduces food intake, lowers body weight, and decreases fat content by reducing calorie intake and modulating appetite; additionally, Tirzepatide has been shown to regulate lipid utilization. The long-term weight management effects of Tirzepatide in obese or overweight adults with weight-related comorbidities are currently in Phase III clinical development.

Previously, Tirzepatide was approved by the FDA on May 13, 2022, for improving glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The potential treatment of Tirzepatide is also being studied for obesity or overweight patients with heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA), and non-alcoholic steatohepatitis (NASH). Additionally, studies on the incidence and mortality (MMO) of Tirzepatide in chronic kidney disease (CKD) and obese patients are ongoing.

About Eli Lilly and Company

Eli Lilly and Company is a globally leading pharmaceutical company engaged in the research, development, manufacturing, and marketing of medicines, dedicated to improving human health through innovation. Eli Lilly was founded over a century ago by Colonel Eli Lilly in Indianapolis, Indiana, in 1876. The company's founder committed himself to producing high-quality medicines to meet real healthcare needs. Today, we remain steadfast in this mission and continue our work based on it. Globally, our employees constantly strive to develop medicines that can make a difference in people’s lives and deliver them to patients who truly need them. Beyond that, we are also devoted to enhancing public understanding of diseases and improving disease management while giving back to society through philanthropy and volunteer activities. With the philosophy of "Rooted in China, benefiting China," Eli Lilly is expanding its business in China and has taken a leading position in areas such as diabetes, oncology, immunology, pain management, and neurodegenerative diseases. For more information about Eli Lilly and Company, please visit: www.lilly.com.

References

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1. L Z. Efficacy and safety of tirzepatide once weekly in Chinese participants with obesity or with overweight and weight-related comorbidities. Abstract 542-SO . Presented at the EASD 59th Annual Meeting 2023; 2-6 Oct

2. le Roux CW, Zhang S, Aronne LJ, et al. Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program. Obesity (Silver Spring) 2023; 31(1): 96-110.

3. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med 2022; 387(3): 205-16.

4. Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 2023.

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