Eli Lilly released topline Phase III data on Tuesday showing that after more than three years of follow-up, pre-diabetic patients treated with tirzepatide were less likely to progress to type 2 diabetes.
Eli Lilly’s blockbuster incretin therapy tirzepatide—sold as Mounjaro for type 2 diabetes and as Zepbound for chronic weight management—strongly reduces the risk of diabetes in pre-diabetic adults who are also overweight or obese, according to topline Phase III data released on Tuesday.
After following patients for 176 weeks, the late-stage SURMOUNT-1 trial found that pre-diabetic patients treated with weekly tirzepatide saw a 94% drop in the risk of progressing to type 2 diabetes. Tirzepatide also resulted in consistent weight loss throughout the study period, with the highest dose of 15 mg resulting in a 22.9% average reduction in body weight.
Jeff Emmick, Lilly’s senior vice president of product development, in a statement said that these latest data from SURMOUNT-1 “reinforce the potential clinical benefits of long-term therapy for people living with obesity and prediabetes.” The pharma will submit these results for publication in a peer-reviewed journal, as well as present these findings at ObesityWeek 2024 in November.
BMO Capital Markets analyst Evan Seigerman was impressed with Lilly’s data, writing in an investor note that “we just don’t see numbers like this in metabolic space.”
SURMOUNT-1’s findings “firmly establish application of tirzepatide in a prevention setting,” Seigerman wrote, noting that the readout also helps the pharma establish the long-term benefits of tirzepatide independently of weight loss, which is “key to reimbursement and uptake.”
Participants in SURMOUNT-1 were either overweight or obese, with body mass index at least 30 kg/m2 or 27 kg/m2, respectively, and were previously diagnosed with a weight-related comorbidity, such as hypertension, dyslipidemia and obstructive sleep apnea. Participants also had a history of at least one unsuccessful dietary effort to lose weight.
Tirzepatide was given in three doses—5 mg, 10 mg and 15 mg—to supplement lifestyle adjustments including a lower-calorie diet and higher physical activity. In June 2022, Lilly published 72-week data from SURMOUNT-1 highlighting the therapeutic potential of tirzepatide for obesity. At the lowest dose, patients dropped an average of 15% of their body weight, climbing to 19.5% and 20.9% in the two higher dose levels, respectively.
SURMOUNT-1 then followed more than 1,000 patients who had pre-diabetes at baseline for 104 more weeks to assess the long-term effects of tirzepatide on weight and disease progression. Monday’s readout comes from this extended monitoring.
With tirzepatide, Lilly occupies a dominant position in the lucrative and rapidly growing obesity market, alongside frontrunner Novo Nordisk. The Danish drugmaker owns the blockbuster GLP-1 receptor agonist semaglutide—marketed as Ozempic for diabetes and Wegovy for weight loss—which beat Lilly’s competing products to the market.
However, the Indiana-based pharma has steadily been gaining ground—and Monday’s readout could help it close the gap even further. According to Seigerman, Novo’s Phase III SELECT study showed that semaglutide can reduce the risk of progression from pre-diabetes to type 2 diabetes by only 73%. Lilly’s SURMOUNT-1 results “compare favorably” with Novo’s data, he wrote.
