AstraZeneca has unveiled promising results from the early-stage trial of its oral GLP-1 agonist, AZD5004, at the ObesityWeek conference in San Antonio this week. The UK pharmaceutical company, which gained widespread recognition for its COVID-19 vaccine, presented data showing that AZD5004 performed similarly to current injectable GLP-1 agonists, which are used to treat both obesity and type 2 diabetes. The drug is now undergoing two Phase IIb studies, with results expected as early as late 2025.
The oral formulation of AZD5004 is AstraZeneca’s major entry into the rapidly growing obesity drug market, positioning it alongside established players like Novo Nordisk, the maker of Ozempic (for diabetes) and Wegovy (for obesity). If successful, AZD5004 could offer a more convenient alternative to current injectable treatments.
In a Phase I trial involving 72 participants—comprising healthy non-obese individuals and those with type 2 diabetes—the drug was found to be safe at doses under 50 mg. However, higher doses were linked to an increase in gastrointestinal side effects, similar to those reported with other GLP-1-based drugs on the market. Participants experienced an average weight loss of 5.8% after just four weeks, along with improvements in fasting plasma glucose levels.
Building on these results, AZD5004 is now moving into Phase IIb trials. The Vista study will assess its efficacy in obesity treatment, enrolling 304 participants, with results expected by the end of 2025. A separate trial, the Solstice study, will evaluate its impact on type 2 diabetes, with 384 patients participating and results anticipated by early 2026.
AstraZeneca licensed AZD5004 from Chinese biopharma company Eccogene in 2023 for nearly US$2 million. However, the company is optimistic that, if the drug proves successful in subsequent trials, it could generate up to $800 million in sales by 2032.
“We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies, both as a potential monotherapy and in combination for cardiometabolic diseases such as type 2 diabetes, as well as for obesity,” said Sharon Barr, AstraZeneca’s executive vice president, following the deal with Eccogene.
In addition to AZD5004, AstraZeneca is exploring a combination therapy with AZD6234, a long-acting amylin analogue currently in a Phase IIb trial for weight loss. The company believes this pairing could result in more targeted and effective fat loss. Though Barr did not disclose a timeline for the combination trial, she noted that early Phase I data had provided confidence in the strategy.
Despite being several years behind leaders in the field, like Novo Nordisk and Eli Lilly, AstraZeneca’s late entry into the obesity drug market comes at a time of increasing demand for obesity treatments, particularly oral options. The company’s competitors, including Viking Therapeutics, which is also developing an oral obesity drug, are showing similar early-stage results, with its dual GLP-1/GIP co-agonist VK2735 achieving up to 8.2% weight loss in 28 days at its highest dose.
AstraZeneca’s AZD5004 is a promising candidate, and if it continues to meet safety and efficacy benchmarks, it could become a key player in the growing market for obesity and metabolic disease treatments.
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