Tirzepatide Demonstrates Significant Benefits for Patients with Pre-Diabetes, Obesity Over 176 Weeks

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Data from the Phase III SURMOUNT-1 study found that Eli Lilly’s tirzepatide (Zepbound and Mounjaro) demonstrated sustained, clinically significant benefits for adults with pre-diabetes and obesity or overweight over a 176-week treatment period. According to the company, weekly injections of 5 mg, 10 mg, 15 mg doses with tirzepatide significantly reduced the risk of progression to type 2 diabetes. Final results were published in The New England Journal of Medicine and presented at ObesityWeek 2024.¹

"Individuals treated with tirzepatide lost on average up to 23% of their body weight and maintained this for over three years, while benefitting from a substantial decrease in risk of developing type 2 diabetes. In absolute terms, nearly 99% of individuals treated with tirzepatide remained diabetes-free at 176 weeks," said Ania Jastreboff, MD, PhD, director, Yale Obesity Research Center, in a press release. "These results are impressive given the degree of sustained weight reduction and decrease in risk of diabetes."

The multi-center, randomized, double-blind, parallel, placebo-controlled SURMOUNT-1 trial compared the efficacy and safety of tirzepatide 5 mg, 10 mg, and 15 mg to placebo as an adjunct to a reduced-calorie diet and increased physical activity in adults without type 2 diabetes who had obesity or overweight, with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease. A total of 1,032 study patients who had pre-diabetes stayed in the trial for an additional 104 weeks of treatment following the initial 72-week completion date to evaluate the impact on body weight and potential differences in progression to type 2 diabetes at three years of treatment with tirzepatide compared to placebo.

Results found that tirzepatide achieved substantial average weight loss of 22.9% at the 15 mg dose, with 99% of participants remaining diabetes-free compared to placebo. In the 5 mg and 10 mg doses, the treatment achieved a weight loss average of 15.4% and 19.9%, respectively. Additionally, tirzepatide reduced the risk of developing type 2 diabetes by 94% and showed positive effects on glycemic control, cardiometabolic health factors, and quality of life.

Common adverse events included COVID-19, nausea, diarrhea, and constipation, with most symptoms being mild to moderate in severity. The overall safety and tolerability profile of tirzepatide 193 weeks was found to be consistent with the previously published results at 72 weeks for SURMOUNT-1 and other tirzepatide clinical studies conducted for weight reduction and long-term maintenance.¹

According to the Centers for Disease Control and Prevention, 11.6% of the US population had some form of diabetes. This included 38.1 million adults over 18 years of age, with prevalence increasing with age. By 65 years of age, 29.9% of the population had a form of diabetes, according to the statistics. Further, 8.7 million adults over 18 years of age who met laboratory criteria for diabetes were not aware of or did not report having diabetes.²

"In the SURMOUNT-1 three-year study of tirzepatide, an average weight reduction of up to 22.9% was accompanied by a hazard ratio of 0.06 for progression to type 2 diabetes. This translates to a risk reduction of 94% and a number needed to treat of nine to prevent one case of diabetes," said Jeff Emmick, MD, PhD, SVP, product development, Lilly, in the press release. "These results underscore the critical role of long-term therapy with effective treatments like tirzepatide to achieve and maintain weight reduction."

References

1. Treatment with tirzepatide in adults with pre-diabetes and obesity or overweight resulted in sustained weight loss and nearly 99% remained diabetes-free at 176 weeks. Lilly. November 13, 2024. Accessed November 14, 2024. https://investor.lilly.com/news-releases/news-release-details/treatment-tirzepatide-adults-pre-diabetes-and-obesity-or

2. National Diabetes Statistics Report. CDC. Accessed November 14, 2024. https://www.cdc.gov/diabetes/php/data-research/index.html