"While type 2 diabetes and obesity are the main diseases currently treated with blockbuster GLP-1 drugs, the next goal for Novo Nordisk and Lilly is to expand on other indications for GLP-1.”

 When it comes to GLP-1 drugs, we have to mention the king of the track, —— Novo Nordisk and Eli Lilly.

For GLP-1 receptor agonists, the two giants are conducting a series of clinical trials for indications other than obesity and diabetes, diversifying the use of GLP-1 drug blockbuster drugs.

 GLP-1 development and popularity road

 GLP-1 receptor agonists, originally used to treat type 2 diabetes, rose to prominence for their effectiveness in weight loss. Indeed, GLP-1 has become the main drug class for discussing weight loss. For example, in a review article on the future of obesity treatment published in the journal Nature in February, the authors specifically identified innovations in the field of GLP-1.

Despite the current focus on diabetes and obesity, studies suggest that GLP-1 has broad pharmacological potential.

 A review by the National Institutes of Health (NIH) suggests that, in addition to the traditionally understood hormonal benefits, this drug class " is cardiac and neuroprotective, reduces inflammation and apoptosis, and has effects on learning and memory, rewarding behavior, and palatability.

In fact, GLP-1 studies have diversified to include non-alcoholic fatty liver disease, polycystic ovary syndrome, peripheral artery disease, and cardiovascular health.

 The Lilly GLP-1 project extension

 The main extension of the Lilly GLP-1 program is sleep apnea (OSA). On April 17, Lilly released the positive study results of the Phase tirzepatide III SURMOUNT-OSA trial, which reached all primary and critical secondary endpoints. Trial data showed that the Tirzepatide apnea-hypopnea index (AHI) decreased approximately 60% (related events compared to placebo) to the primary endpoint. Lilly plans to list with the FDA and other global regulators in the middle of the year, after the Tirzepatide has received a fast-track FDA designation for the treatment of moderate to severe OSA combined with obesity.

 Eli is also studying the use of tirzepatide in MASH, and the results of a phase II clinical trial released in June showed that the drug is superior to placebo. In addition, Lilly's GCGR / GIPR / GLP-1R new triple agonist resitrolutide (Retatrutide) is also in phase III clinical trials for sleep apnea and knee osteoarthritis, as well as obesity and T2D, and the results are expected to be released in 2026.

 In the cardiovascular field, Eli Lilly also conducted a phase tirzepatideIII trial to investigate the effect of the drug on the long-term risk of atherosclerotic cardiovascular disease (ASCVD) and on ejection fraction preserved heart failure with obesity. Published treatment results for the former indication, released last year 11, showed that the therapy significantly reduced the 10-year predicted risk of ASCVD, but Lilly has not yet planned to apply for approval in this area.

At present, Tirzepatide has launched 26 phase III clinical trials, starting to enter new markets in addition to hypoglycemic and weight loss.

 The GLP-1 project extension of Novo

The world's first anti-obesity drug, Smegallutide Wegovy, a GLP-1 drug developed by Novo Nordisk, was approved as a weight-loss drug in the United States in June 2021. Novo Nordisk this year extended the GLP-1 program to the area of reducing cardiovascular risk. On March 8, the FDA approved new indications for simegallutide injection semaglutide for preventing the risk of heart attack, stroke and cardiovascular death in overweight or obese adults. This marks another important breakthrough in the prevention of the treatment of "comorbid" obesity. At the same time, Novo Nordisk announced the results of a phase IIIb trial of semaglutide for kidney disease: 1.0mg sommarutide had a 24% lower risk of kidney-related events in patients with type 2 diabetes and chronic kidney disease. Novo plans to apply to regulators in the United States and Europe this year for approval of semaglutide for the treatment of kidney disease. Novo is also in a phase III trial of MASH, which is expected to be completed in 2029. In addition, Novo is also testing the efficacy of semaglutide in treating AD, and the results of the phase III trial are expected to be released by the end of 2026. An observational study published in July found that patients with type 2 diabetes taking semaglutide had a lower risk of dementia, cognitive deficits, and nicotine abuse.

 GLP-1 market interpretation

 A June industry report estimated that the global GLP-1 market was valued at $36.8 billion in 2023 and is expected to grow to $138 billion by 2031.

Market size for type 2 diabetes and obesity compared to GLP-1.‍Novo and Lily are exploring a much smaller market for new indications, but may still expand the margins of GLP-1 treatment.

The global Alzheimer's market will grow from $4.8 billion to $8.18 billion by 2032, with a compound annual growth rate of 8.7% from 2024-2032. And MASH / NASH will grow from $1.62 to $24.2 billion.

Although these markets are smaller than the market for diet pills, the lure of GLP-1's ability to treat such a wide range of diseases is still driving Novo and Lily to expand their reach."I think weight loss will still be dominant," said James Shehan, a former long-time adviser to Novo."But I think there will be a growing recognition that obesity is a complex syndrome. By treating obesity, you can address a range of physical diseases that people may suffer from.”

If GLP-1 drugs are successfully approved for the treatment of NASH, polycystic ovary syndrome, sleep apnea, diabetes prevention and other fields, the demand for GLP-1 drugs will continue to grow in the future.

References:

https: / / www.biospace.com/

https://trials.lilly.com/

https://www.novonordisk.com/

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