Eli Lilly shared new data last week from a study, which highlights the long-term efficacy of tirzepatide in preventing diabetes progression among prediabetic patients.
Results from the Phase III SURMOUNT-1 three-year study (176-week treatment period) showed that nearly 99 percent of participants remained diabetes-free over three years. SURMOUNT is the longest completed study to date of tirzepatide.
Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.
In a news release announcing the results, Lilly said the results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide.
Tirzepatide led to an average sustained weight loss of 22.9 percent with the 15 mg dose through the three-year treatment period.
And at the 193-week mark, following a 17-week off-treatment follow-up period, only 2.4 percent of patients receiving the treatment were diagnosed with type 2 diabetes compared with 13.7 percent in the placebo group.
The findings of the study were published in The New England Journal of Medicine (NEJM) and recently presented at ObesityWeek 2024.
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Tirzepatide, a dual GIP (glucose-dependent insulinotropic polypeptide)/GLP-1 (glucagon-like peptide-1) receptor agonist, has been a blockbuster treatment for type 2 diabetes and obesity, along with semaglutide rivals Ozempic and Wegovy from Novo Nordisk.
It’s the first and only approved dual agonist targeting both the GIP and GLP-1 receptors. These gut hormones are released in response to nutrient intake and play a crucial role in the incretin effect, which enhances insulin secretion.
The latest data focuses on its preventative potential, targeting individuals with prediabetes, a condition where blood sugar levels are elevated but not yet at the threshold for a diabetes diagnosis.
The study looked at tirzepatide’s ability to stabilize blood sugar levels and prevent the onset of type 2 diabetes. Participants were selected based on their prediabetic status, and the trial compared tirzepatide with a placebo.
Lilly’s SURMOUNT study enrolled 1,032 patients with prediabetes, randomly assigning them to receive one of three doses of tirzepatide or a placebo, alongside a reduced-calorie diet and increased physical activity. Participants in the trial also had comorbidities such as hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease or a combination of these conditions.
Researchers monitored a range of health metrics, including fasting glucose, HbA1c levels and weight changes. They found that tirzepatide led to improvements in glycemic control, cardiometabolic risk factors (including fasting insulin, blood pressure and lipids) and health-related quality of life, which were sustained through 176 weeks.
In addition to preventing diabetes, tirzepatide supported substantial weight loss among participants, further contributing to reduced diabetes risk.
Jeff Emmick, MD, PhD, senior vice president, product development, Lilly said, “These results underscore the critical role of long-term therapy with effective treatments like tirzepatide to achieve and maintain weight reduction.”
According to the Centers for Disease Control and Prevention (CDC), approximately 98 million, or one in three, adults in the US, have prediabetes. And the American Diabetes Association (ADA) reports that 1.2 million Americans are diagnosed with diabetes every year.
Tirzepatide has achieved several notable milestones this year, which could help it secure expansions in other indications beyond its primary uses in diabetes and obesity.
In August, tirzepatide showed positive results in the late-stage SUMMIT study involving 731 patients with heart failure with preserved ejection fraction and obesity. Tirzepatide cut the risk of adverse heart failure outcomes, such as hospitalization or cardiovascular death, by 38 percent compared with placebo. The drug also alleviated heart failure symptoms and improved patients’ physical limitations compared with placebo.
Based on this data, Lilly said it plans a data submission to the US Food and Drug Administration (FDA) and other regulatory bodies before the end of the year.
Related: Eli Lilly’s Tirzepatide Shows Promise in Treating Fatty Liver Disease
In June, Lilly shared data from the Phase II SYNERGY-NASH trial, which showed that 51 percent on tirzepatide 15 mg achieved at least one stage of fibrosis improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH). The numbers were similar for the 5 mg and 10 mg doses (54.9 percent and 51.3 percent, respectively). In contrast, only 29.7 percent of MASH patients in the placebo group saw similar fibrosis improvement.
While GlobalData predicts that Mounjaro and Zepbound will contribute to GLP-1 drugs becoming the best-selling drug class this year, sales of the drugs have been slightly lower than anticipated.
In the third quarter of 2024, Mounjaro’s type 2 diabetes sales reached $3.11 billion, falling short of analysts’ projections of $3.7 billion. Similarly, Zepbound’s sales in obesity totaled $1.26 billion, below the anticipated $1.7 billion.
The results were in sharp contrast to Mounjaro’s substantial growth from $1.81 billion in first-quarter sales to $3.09 billion in the second quarter. Zepbound also saw significant revenue growth, rising from $517 million to $1.24 billion over the same period.
Taking into account the dips, Lilly’s new projection for 2024 sales of the tirzepatide pair is now $46 billion.
However, Lilly executives are not concerned about the slightly lower revenues in the latter half of the year.
According to Fierce Pharma, on the company’s third-quarter earnings call, Patrik Jonsson, Eli Lilly’s president of cardiometabolic health, noted that, “The underlying market for both type 2 (diabetes) and obesity continues to grow.” As such, he said Lilly “took a more prudent approach than we anticipated in Q3, pretty much driven by the need to deliver a good consumer experience.”
Jonsson also shared that Lilly is “investing heavily” in direct-to-consumer efforts for tirzepatide. Meanwhile, president of Eli Lilly International, Ilya Yuffa, said new launches overseas should begin to bring in more sales in the fourth quarter.
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