Searching for new weight loss treatments
Globally, an estimated 462 million people are affected by type 2 diabetes, many of whom are overweight or obese. In the UK, it has been estimated that 4.6 million people are living with a diabetes diagnosis, and a further 1.3 million could be living with undiagnosed type 2 diabetes. At the same time, a surge in obesity levels generally is impacting the nation’s health and placing a huge strain on NHS resources.
To tackle obesity, drug developers have introduced a range of glucagon-like peptide-1 receptor agonist (GLP-1 RAs) drugs, including Mounjaro, Zepbound, Wegovy, and Ozempic, which work by activating the GLP-1 receptor suppressing appetite, slowing digestion, and regulating blood sugar. They have proven to be highly successful, with studies demonstrating that overweight patients who are prescribed Mounjaro, for example, can expect to lose between 15-22% of their body weight over 72 weeks.
GLP-1 RAs in United Kingdom
In the UK, GLP-1 RAs are typically prescribed for patients with type 2 diabetes who use them to help control their dietary intake and regulate blood sugar levels, whilst mitigating the risk of becoming insulin dependent. GLP-1 RAs are increasingly prescribed for obese patients with other chronic health conditions too, such as non-alcoholic fatty liver disease and sleep apnoea, as well as for those with metabolic and cardiovascular diseases, and some forms of cancer.
Despite their efficacy in helping people lose weight, GLP-1 RAs can cause side effects such as nausea, constipation, and diarrhoea. In August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for all GLP-1 RAs, including semaglutide, which is sold under the brand names Wegovy, Ozempic, and Rybelsus, tirzepatide, which is sold under the brand name Mounjaro, and liraglutide, which is sold under various brand names. Specifically, the guidance states that GLP-1 RAs are “medicines licensed to treat specific medical disorders and should only be used if you are overweight or diabetic, and not if you want to lose weight for aesthetic or cosmetic purposes”. In most cases, the side effects experienced are mild to moderate. However, there have been a small number of more serious cases reported, where people have experienced acute pancreatitis. Research also indicates that these treatments can cause significant muscle loss, which means they may not be suitable for certain patient groups.
Responding to market opportunity and investor interest
Despite the potential side effects, global demand for GLP-1 RAs is growing exponentially – a mark of just how successful these drugs have been in tackling obesity. In fact, some analysts predict that the global market for weight loss drugs could reach $100 billion by 2030.
With so much market opportunity and investor interest, competition is intense and pharma companies have been exploring ways to target the GLP-1 receptor with different compounds in the hope of discovering a new drug with improved characteristics that could provide a competitive edge. Other companies are focusing their research efforts on different receptors, hoping to find an alternative weight loss therapy that produces the same effect by a different biological pathway.
By far the most popular weight loss treatments available currently are injectables, but there are drawbacks such as limited accessibility and high cost. The dominant market players are developing oral treatments, which could be more cost-efficient to produce and easier to distribute. For example, Eli Lilly is developing a new small molecule, which is taken as a daily pill. Known as orforglipron, it targets the same receptor (GLP-1) and is currently undergoing clinical trials for the management of type 2 diabetes and weight loss. Eli Lilly has filed patent applications covering orforglipron oral capsule formulations (WO 2023220109 A1), as well as oral dosage regimens for treating type 2 diabetes and obesity (EP 4633632 A1). Novo Nordisk has also developed an oral version of its semaglutide weight-loss treatment, Wegovy, which is currently awaiting regulatory approval in the US. For example, the company has recently filed a patent application covering semaglutide tablets with improved bioavailability (WO 2024110614 A1). Whilst a shift to oral treatments should improve access to weight-loss treatments, most companies with a stake in the market are continuing other more speculative R&D activity in parallel.
As might be expected, the rapid growth in demand for weight loss drugs has encouraged many new entrants, with some marketing compounded versions of the most successful branded therapies. Whilst patents granted for GLP-1 RAs can be leveraged to block the sale of copy-cat drugs or similar drugs in key global markets, many manufacturers are keen to develop alternative treatments that are safe and effective, with a view to avoid any patent infringement and to secure their own exclusive rights to commercialise them.
Pursuing its own blue-sky strategy, Novo Nordisk is exploring whether its existing weight loss treatment, Wegovy, could be repurposed to treat people with Alzheimer’s – a move that could open up a major new market opportunity for this existing, approved drug.
Other R&D activity is more ambitious in scope. For example, a team of research scientists at Stanford University has been looking for alternative solutions that could provide an effective obesity drug. An innovative discovery model has screened over 2,500 previously uncharacterised peptides and found that BRINP2-related peptide (BRP), a non-incretin hormone, may provide a natural alternative to GLP-1 RAs. Appearing to work independently of classical metabolic receptors through an unidentified receptor, early feedback from pre-clinical trials has been promising, suggesting that BRP could be effective and generate fewer side effects than traditional GLP-1 RAs.
Amgen is currently developing a weight loss treatment that combines an antibody with GLP-1 peptides in a bid to develop a solution that is safer and more effective than those available at the moment. Currently undergoing Phase III clinical trials, MariTide’s patented technology works in a similar way to other weight loss drugs by activating the GLP-1 receptor in order to suppress appetite, but blocks the GIP receptor at the same time, which it hopes could improve outcomes further.
With so much exploration underway involving companies of all sizes across the drug discovery market, it is vital that innovative formulations, as well as new molecules and peptides, are patented in key global markets at an early stage. This is key to securing a stake in a fast-developing market. Using IP intelligence to guide R&D activity can also help companies to develop treatments that are more effective, with fewer side effects.
Whilst weight loss therapies will continue to evolve, one thing is certain, global demand for a drug that can protect our health and improve our appearance is bound to grow.
About the authors
Adrian Tombling is a partner and patent attorney at European IP firm, Withers & Rogers, with extensive experience advising pharmaceutical, biotechnology, and medical device companies across Europe. As head of Withers & Rogers’ Munich office, Tombling specialises in patent work relating to recombinant DNA technology, gene therapy, recombinant antibodies, diagnostic tests, screening methods, and vaccines. He also supports AI-driven drug discovery organisations and has significant expertise in opposition and appeal procedures before the European Patent Office.
Nicholas Watermeyer is an associate and patent attorney at European IP firm, Withers & Rogers, specialising in chemistry and life sciences, and supporting clients across specialist chemicals, batteries, pharmaceuticals, polymers, packaging, minerals and mining, biochemistry, and bioprocessing. His practice covers drafting and prosecuting patent applications, as well as advising on freedom-to-operate, infringement, and validity assessments. Watermeyer tailors his strategic guidance to the needs of diverse client types, from SMEs and universities through to multinational companies.
