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AstraZeneca’s Oral GLP-1 Moves Into Late-Stage Trials as the Weight-Loss Drug Race Shifts From Syringes to Pill Boxes

elecoglipron delivered double-digit weight loss in a mid-stage trial, bringing AstraZeneca closer to the oral obesity drug market; but efficacy, tolerability, and differences from similar drugs will only become truly clear in Phase 3.

By SURL BioNews

As GLP-1 drugs push obesity treatment into mainstream medicine, the next battleground is no longer only who can deliver greater weight loss, but who can put efficacy, convenience, and long-term affordability into a single daily tablet. After AstraZeneca released Phase 2 data for its oral GLP-1 receptor agonist elecoglipron, the company said it would advance the drug into Phase 3 trials, meaning the British drugmaker has formally placed itself in the highly competitive lineup of oral weight-loss drugs.

According to the Financial Times and other reports on the same event, elecoglipron is a once-daily oral drug that produced weight loss of up to 11.8% in a mid-stage obesity study. The Times further reported that the VISTA trial has been published in The Lancet and enrolled about 300 participants who were overweight or obese but did not have type 2 diabetes, with sites in Australia, Canada, Germany, Japan, Taiwan, the United Kingdom, and the United States.

In that trial, the highest dose of 75 mg produced an average weight loss of 10.5% at 26 weeks, compared with 0.6% in the placebo group; when extended to 36 weeks, the weight-loss figure rose to 11.8%. Those numbers are enough to support late-stage development, but they also remind the market that if the convenience of an oral drug is to become a clinical advantage, it cannot rely only on its route of administration. It must also find a stable balance between efficacy and side effects.

At the same time, another global trial in patients with obesity and type 2 diabetes enrolled more than 400 people, according to The Times. Nearly three-quarters of those receiving elecoglipron lost at least 5% of their body weight within six months, compared with about one-fifth in the placebo group. This is especially important for metabolic disease treatment, because obesity and diabetes are often intertwined in the same clinical setting. Physicians need not only weight figures, but also overall evidence on blood glucose, cardiovascular risk, and long-term adherence.

On safety, the commonly reported adverse events listed in reports included nausea, diarrhea, constipation, and vomiting, consistent with the common profile of GLP-1 drugs. Cinco Días, citing Bloomberg, reported that the discontinuation rate for elecoglipron due to side effects was about 5%; by comparison, Eli Lilly’s oral candidate Foundayo has been cited in some data as having a discontinuation rate as high as 17%. However, cross-trial comparisons are inherently limited. Differences in participant populations, dose design, and observation periods can all change the apparent ranking of strengths and weaknesses.

The investment market’s reaction also revealed the detailed pressures in this race. Cinco Días/Bloomberg reported that AstraZeneca’s share price fell as much as 1.9% after the data were released, while shares of large European drugmakers were also broadly weaker at the time. Barclays analysts said that if the Phase 2 results can be reproduced in Phase 3, elecoglipron could become a credible option, but it has not yet shown a clear clinical difference versus Lilly’s Foundayo. The reports also noted that Foundayo’s mid-stage trial has been cited as reaching 14.7% weight loss, higher than the current maximum of 11.8% reported for elecoglipron.

Background Context

The significance of oral GLP-1 lies in moving obesity drugs, which have mostly been injection-based, toward a format closer to everyday chronic disease management. This could improve some patients’ acceptance of treatment and may also expand the imagination around prescribing and supply chains. But obesity treatment is not a sprint. Phase 3 will need to answer, at larger scale and over a longer period, whether weight can continue to fall, what rebound looks like after discontinuation, whether gastrointestinal side effects are manageable, and whether risks and benefits are consistent across different populations. elecoglipron has now crossed an important threshold, not the finish line.

References

  1. The Times
  2. Cinco Días / Bloomberg