Eli Lilly’s weight loss pill Foundayo has had a “slower-than-hoped” launch, according to BMO Capital Markets, which contended that the indirect comparison data—despite falling short of definitive proof of superiority—could help the Indiana giant build momentum for its oral drug.
Eli Lilly, running to catch up to Novo’s oral Wegovy, has presented “indirect but encouraging” comparisons for its rival GLP-1 products aiming to show that the drugs spur greater weight loss.
In one analysis, Lilly drew data from Phase 3 ACHIEVE-3 trial and Novo’s Phase 3b PIONEER PLUS study, according to a Tuesday announcement at the ongoing European Association for the Study of Diabetes conference. The analysis showed that a 17.2-mg dose of Lilly’s oral medication Foundayo elicited 1.5% to 2.4% greater weight loss versus oral semaglutide, with consistent results seen across the statistical methods used, according to Lilly.
Similarly, Lilly’s pill resulted in 0.3% to 0.6% greater reduction in HbA1c—an indicator of average blood sugar over a certain stretch of time—than oral semaglutide. Change in HbA1c was the primary endpoint of both ACHIEVE-3 and PIONEER PLUS.
“These analyses are directionally favorable for Lilly, supporting Foundayo’s oral profile and reinforcing Zepbound’s position at the leading edge of obesity efficacy,” BMO Capital wrote in a Tuesday note. The firm however cautioned that, without direct head-to-head evidence from a single trial, these findings aren’t enough to establish definitive superiority over Novo’s products. The analysts therefore dubbed the EASD readout as “indirect but encouraging.”
Indirect comparisons don’t account for differences in study design, patient populations, treatment adherence and other factors that could bias the analysis, BMO Capital Markets said. “We therefore view the data as supportive and commercially useful rather than a form of definitive proof.” The indirect analyses “could help build momentum around Foundayo following a slower-than-hoped launch start.”
In a statement, Lilly pointed to the Foundayo analysis as a way to provide “informative data points.”
ACHIEVE-3 enrolled nearly 1,700 patients with inadequately controlled type 2 diabetes, comparing 9 mg or 17.2 mg of Foundayo against 7 mg or 14 mg of Rybelsus, an earlier oral version of semaglutide indicated for type 2 diabetes. Meanwhile, PIONEER PLUS had more than 1,600 participants with type 2 diabetes who were started on 3 mg oral semaglutide, gradually increased to a randomly assigned final dose of 14 mg, 25 mg or 50 mg. Data from PIONEER PLUS supported the approval of oral Wegovy in December 2025.
Novo has claimed the first round in the oral obesity battle, with the launch of oral Wegovy exceeding expectations and hitting around $355 million in sales in the first quarter—coming 86% ahead of analyst forecasts. Q2 sales for oral Wegovy further jumped to $496 million, while Foundayo trailed with $98 million that quarter. At a Capital Markets day earlier this month, Novo CEO Maziar Mike Doustdar said that the Wegovy pill has reached 7 million prescriptions, making it the best U.S. launch ever by volume.
In a separate analysis, Lilly on Tuesday also presented indirect comparison data showing up to 4.5% greater weight reduction in patients on the injectable weight-loss therapy Zepbound compared to those treated with high-dose injectable Wegovy. Patients treated with Zepbound were also up to three times more likely to lose at least 20% of their body weight than Wegovy.
The Zepbound data came from Lilly’s SURMOUNT-1 study, which compared the GLP-1/GIP agonist to placebo in patients who are overweight or obese without type 2 diabetes. Data for high-dose Wegovy, meanwhile, came from Novo’s STEP UP study, which similarly compared injectable semaglutide against placebo and enrolled patients with obesity who are overweight but without type 2 diabetes. Both trials primarily tested for weight loss.
Lilly previously tested Zepbound against lower doses of injectable Wegovy in a Phase 3 head-to-head trial called SURMOUNT-5, finding greater weight loss for its asset. The EASD analysis shows the same may be true for the high-dose option that Novo now offers, Thomas Seck, senior vice president of product development at Lilly Cardiometabolic Health, said in a statement.
