USA — Pharmaceutical company Eli Lilly has registered a phase 3b clinical trial on clinicaltrials.gov for its weight loss drug, Mounjaro.
The study, known as SURMOUNT-5, will compare the effectiveness of Mounjaro with Novo Nordisk’s weight loss drug, Wegovy, in overweight patients with weight-related health conditions or those who are obese.
The new SURMOUNT-5 trial requires participants to have a body mass index (BMI) of at least 30kg/m2 or at least 27kg/m2 with a prior diagnosis of one of four weight-related disorders: hypertension, dyslipidemia, obstructive sleep apnea, and cardiovascular disease.
While Wegovy received FDA approval in 2021 for chronic weight management in obese and certain overweight patients, Mounjaro is currently approved for treating Type 2 diabetes.
The trial is set to enroll 700 participants from various countries, including the U.S., Canada, South America, and Europe, and is expected to last for approximately 78 weeks, with a primary completion date in February 2025.
The primary endpoint of the study will compare the percentage of weight loss from baseline between the two drugs after 72 weeks.
It is unclear whether Lilly is conducting a superiority study to demonstrate that Mounjaro is better than Wegovy, or if the study will only show noninferiority.
Secondary measurements will include the percentage of patients who achieve a specific level of weight loss.
There are also two other phase 3 trials for Mounjaro in obesity expected to report results soon. SURMOUNT-3 will assess Mounjaro in combination with intensive lifestyle modification therapy, while SURMOUNT-4 will evaluate the benefit of continued Mounjaro treatment.
Both Mounjaro and Wegovy have gained considerable attention and popularity, thanks to celebrity endorsements and viral social media posts.
High demand for both drugs resulted in a shortage that lasted for several months, but the companies have since resolved the issue.
The increasing demand for weight loss solutions has generated enormous sales projections, as the market remains largely underserved.
In 2020, UBS analysts projected that Mounjaro, with its potential to treat both obesity and diabetes, could reach an astonishing US$25 billion in peak sales.
However, some analysts have been more conservative in their estimates, suggesting that the drug’s sales potential may be at or below US$10 billion.
A November 2020 report from Cowen analysts predicted that the global obesity drug market could reach US$30 billion by 2030, with Lilly and Novo leading the way.
Morgan Stanley was even more optimistic, estimating that the market could be worth as much as US$50 billion.
Recently, Lilly launched a rolling FDA submission for Mounjaro in obesity, with plans to launch the drug later this year under a different brand name.
Novo’s semaglutide injection is marketed under the commercial name Ozempic in diabetes.
Wegovy and Mounjaro belong to different drug classes, with Wegovy being a GLP-1 agonist and Mounjaro a dual GLP-1/GIP agonist. Theoretically, the latter may lead to a stronger weight loss effect.
In a previous phase 3 trial, Mounjaro achieved a weight reduction of up to 21% in non-diabetic patients in the SURMOUNT-1 study.
On the other hand, Wegovy demonstrated an average weight loss of 12.4% in its own trial in patients without diabetes.
However, without a direct comparison, it is difficult to determine the superiority of one drug over the other.
As Lilly anticipates significant demand for its diabetes and obesity products, the company is actively expanding its manufacturing capacity.
Lilly has plans for a US$3.7 billion investment in two new active pharmaceutical ingredients sites at the LEAP Innovation Park in Indiana and an additional US$1.7 billion for a plant dedicated to diabetes and obesity drugs in North Carolina’s Research Triangle Park.
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