Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial

Dive Brief:

A pill from Structure Therapeutics helped people in a Phase 2 trial in obesity lose as much as 15% of their body weight over 44 weeks, results that suggest the drug, aleniglipron, could be competitive with rival medications from Eli Lilly and Novo Nordisk.
Treatment was also associated with a lower rate of study discontinuations than what had been seen earlier, after Structure incorporated a new strategy involving a slower step-up in dosing. Structure said that only one enrollee who got a dose of 120 milligrams daily or higher dropped out because of a side effect.
Structure shares rose as much as 6% in morning trading. Leerink Partners analyst David Risinger characterized the results as “best-in-class weight loss” data, while RBC Capital Markets analyst Trung Huynh wrote that the pill looks like “another potential oral option to the market that will be competing for share in the future” with Novo’s Wegovy pill and Lilly’s orforglipron, the latter of which could be cleared in the U.S. within weeks.

Dive Insight:

The launch of Novo’s Wegovy pill, which began in early January, has become a turning point in the treatment of obesity.

Injectable GLP-1 medicines for weight loss have been around for nearly nine years and have become so popular that, for a while, demand outstripped the available supply. Still, the introduction of a pill version has shown there’s still a need for alternative options. The Wegovy pill is off to one of the fastest drug launches ever, with 57,000 people in the U.S. having received prescriptions as of mid-February, according to IQVIA data cited by analysts at RBC Capital Markets.

Competition is about to intensify, too. The FDA is expected to clear orfoglipron sometime in the second quarter of the year. Other large drugmakers like AstraZeneca and Merck & Co. are advancing GLP-1 pills of their own. And in the mix is Structure, a biotech that went public in 2023 and has more than tripled its value since.

Structure’s Phase 2 trial enrolled people with obesity or who are overweight and have a weight-related complication like heart disease, randomizing 61 to receive aleniglipron and 12 to receive a placebo. All the enrollees receiving aleniglipron stepped up their daily dosage from 5 milligrams to 120 milligrams over 20 weeks. At 28 weeks, they were randomized again to either stay on the 120 milligram dose or step up to 180 or 240 milligrams.

Trial investigators measured total weight loss at 44 weeks. The people in the 240 milligram arm who remained on treatment lost, on average, 15% of their body weight. In the 180 milligram arm, the average weight loss was 15.3%. Those in the placebo arm, by comparison, gained a mean 1.1% in weight.

This study, along with previous data, “reaffirms aleniglipron’s potential to be a best-in-class oral GLP-1, with injectable-like efficacy,” said Raymond Stevens, Structure’s CEO, in a statement.

The company expects to meet with the FDA in the second quarter to discuss the design of a pivotal study it hopes will begin in the second half of the year.