Lilly Launches Head-to-Head Phase III Study of Tirzepatide vs. Semaglutide for Weight Management

On April 21, Eli Lilly registered a Phase III clinical trial (SURMOUNT-5) on the ClinicalTrials.gov website, aiming to evaluate the efficacy and safety of Tirzepatide versus Semaglutide (2.4mg) in adult patients with obesity or overweight accompanied by weight-related comorbidities who do not have type 2 diabetes. This is the first head-to-head clinical study of Tirzepatide's weight loss indication against Semaglutide.

This study is a randomized, open-label Phase IIIb study, planning to enroll 700 adult patients with a body mass index (BMI) ≥30kg/m² or ≥27kg/m² who have been previously diagnosed with at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or non-type 2 diabetes.

The primary endpoint of the study was the change in body weight from baseline at week 72 for participants taking Tirzepatide vs Semaglutide (2.4mg); secondary endpoints included the proportion of patients achieving weight loss of 10%, 15%, 20%, 25%, and 30% at week 72, among others.

Tirzepatide is a once-weekly GIPR and GLP-1R agonist. GLP-1 and GIP are two natural incretins, and studies have shown that GIP can reduce food intake and increase energy expenditure, thereby reducing body weight. When GIP is used in combination with a GLP-1 receptor agonist, it may have a greater impact on patients' blood glucose and body weight. In May 2022, Tirzepatide received its first FDA approval for marketing (brand name: Mounjaro) for the treatment of type 2 diabetes.

In May 2022, Eli Lilly and Company announced the Phase III SURMOUNT-1 study data for Tirzepatide in obese patients without diabetes. The enrolled patients had an average weight of 104.8 kg, an average BMI of 38.0 kg/m², and 94.5% of the participants had a BMI ≥30 kg/m².After weekly subcutaneous injections, patients in the 15mg dose group experienced an average weight loss of approximately 8% at week 12, about 16% at week 36, and up to 22.5% (24kg) in the Tirzepatide (5mg, 10mg, 15mg) treatment group by week 72.。

Another Phase III SURMOUNT-2 study targeting adult obesity or overweight patients with type 2 diabetes has been completed this month, with specific results expected to be announced by the end of the month. In September 2022, the FDA granted Tirzepatide Fast Track designation for use in adult obesity or overweight patients. Eli Lilly and Company has currently initiated a rolling submission of a marketing application to the FDA for the weight loss indication.

Novo Nordisk's blockbuster semaglutide (trade name: Wegovy) received FDA approval for its weight loss indication in June 2021. It is indicated for obese patients with a BMI ≥30 kg/m² or a BMI ≥27 kg/m² with comorbidities and is the first and only once-weekly GLP-1 receptor agonist for weight management.After 12 weeks of once-weekly subcutaneous injections, obese or overweight patients in the 2.4mg dose group experienced an average weight loss of around 6%; by 68 weeks, weight loss reached 17-18%.。

Notably, in a large-scale 40-week SURPASS-2 study (n=1879), Eli Lilly's Tirzepatide successfully outperformed Semaglutide. All three doses of Tirzepatide (5mg, 10mg, 15mg) demonstrated superior efficacy in improving blood glucose levels and reducing body weight in adult patients with type 2 diabetes compared to Semaglutide 1mg.

Currently, Novo Nordisk and Eli Lilly are the main competitors in the weight loss market. Both semaglutide and tirzepatide have demonstrated promising efficacy and safety data in large populations. To strengthen their competitive edge, the two companies have respectively advanced clinical trials for oral semaglutide tablets and the oral small-molecule GLP-1R agonist LY3502970 targeting obesity, aiming to capture a share of the multi-billion-dollar weight loss market.

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