Eli Lilly announced topline results of tirzepatide from its SURMOUNT-1 Phase III clinical trial recently. The participants taking tirzepatide drug lost up to 52 pounds (24kg) in the 72-week Phase III study, with 63% of participants taking tirzepatide 15mg achieving at least 20% body weight reductions as a key secondary endpoint. With significant weight loss potential demonstrated in this trial, tirzepatide has the potential to drive the weight loss market, finds GlobalData, a leading data and analytics company.

Tirzepatide is primarily indicated for the treatment of T2D and is expected to receive its decision from the FDA in Q2 2022, although no PDUFA date has been set Tirzepatide is a novel investigational glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide1 (GLP-1) receptor agonist. It is administered once weekly, subcutaneously.

Samisha Khangaonkar, Senior Pharma Analyst at GlobalData, comments: “The weight loss effect tirzepatide demonstrates is impressive. Clinical data has clearly demonstrated that tirzepatide has significantly greater efficacy than the currently marketed GLP-1 inhibitors and is effective at tackling patients with T2D and obesity.”

Currently, obesity is managed through diet, bulking drugs, and appetite suppressors to reduce food consumption and drive weight loss. In June 2021, Novo Nordisk launched and rebranded its T2D treatment and GLP-1 receptor agonist Ozempic (semaglutide) as Wegovy for the treatment of obesity. The launch of Wegovy represented a turning point in the pharmacologic treatment of obesity.

Khangaonkar adds: “The current obesity drugs are not targeted for weight loss and focus on appetite suppression or are label expansions of other marketed drugs. As a result, patients struggled with significant adverse effects and relatively poor efficacy.

“Regulatory approval is particularly difficult to obtain for anti-obesity drugs, with little consistency across global regulatory bodies and their approval criteria. The FDA now requires the results of a long-term cardiovascular outcomes trial in the applications.

Khangaonkar continues: “Like semaglutide, tirzepatide benefits from its position as a T2D treatment in addition to its weight loss benefits, allowing for a greater patient population to be covered, and a greater likelihood of reimbursement. With similar administration and treatment regimens, tirzepatide is poised to compete directly with semaglutide, both on the T2D market and obesity (weight loss) market.

“In the obesity market, the competitive edge between tirzepatide and semaglutide really will come down to the price of tirzepatide, and its ability to negotiate reimbursement with payers. As a first-in-class therapy in a novel drug class, with demonstrated significant efficacy, it has the potential to be priced at a premium, and GlobalData has assumed it will be priced at a 25% premium to other once-weekly GLP-1 receptor agonists.”

Amongst key opinion leaders (KOLs) interviewed, there has been a keen anticipation for the new class of GLP1/GIP dual agonists as these are multi-targeted in their approach. These agonists activate both the GLP-1 receptor as well as the GIP, which alters energy consumption.

Khangaonkar concludes: “Over the next 10 years, tirzepatide is likely to gain significant market share and will be part of a new wave of dual and triple agonist therapies in the T2D market. Because tirzepatide demonstrated superiority over semaglutide, it is likely to become the leading injectable in the GLP-1 space, and its success in the T2D market will likely mirror its success in the obesity (weight loss) market, given the current clinical outcomes.”