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INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a pharmaceutical giant with a market capitalization of $686.5 billion and impressive revenue growth of 37% over the last twelve months, announced Wednesday that its investigational once-daily oral GLP-1 receptor agonist orforglipron demonstrated superior efficacy compared to oral semaglutide in adults with type 2 diabetes in a 52-week head-to-head trial. According to InvestingPro data, the company maintains a strong financial health score of "GREAT," supported by its robust 83% gross profit margin.
In the Phase 3 ACHIEVE-3 clinical trial involving 1,698 adults with type 2 diabetes inadequately controlled with metformin, orforglipron met the primary endpoint by lowering A1C by 2.2% at its highest dose (36 mg) compared to 1.4% with the highest dose of oral semaglutide (14 mg).
For weight loss, a key secondary endpoint, participants taking the highest dose of orforglipron lost an average of 19.7 pounds (9.2% of body weight) versus 11.0 pounds (5.3%) with the highest dose of oral semaglutide, representing a 73.6% greater relative weight reduction.
The trial also showed that 37.1% of participants on the highest orforglipron dose achieved an A1C level below 5.7%, compared to 12.5% of those on the highest oral semaglutide dose.
"In this type 2 diabetes trial, orforglipron, even at the lower dose, outperformed both doses of oral semaglutide in reducing A1C," said Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, according to the company’s press release.
The safety profile of orforglipron was consistent with previous trials, with gastrointestinal-related events being the most common adverse effects. Treatment discontinuation rates due to adverse events were 8.7% (12 mg) and 9.7% (36 mg) for orforglipron compared to 4.5% (7 mg) and 4.9% (14 mg) for oral semaglutide. InvestingPro analysis reveals that Eli Lilly’s strong market position is reflected in analysts’ bullish outlook, with 14 analysts recently revising their earnings estimates upward for the upcoming period.
Lilly expects to submit orforglipron for regulatory approval for the treatment of type 2 diabetes in 2026. Detailed results from the ACHIEVE-3 trial will be presented at a future medical meeting and published in a peer-reviewed journal. For investors seeking deeper insights into Eli Lilly’s financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available as part of its premium subscription, which covers over 1,400 US stocks with detailed metrics and expert analysis.
In other recent news, Eli Lilly has been in the spotlight with multiple developments surrounding its obesity drug, Orforglipron. The company plans to submit the drug for regulatory approval in several major markets almost simultaneously, as confirmed by Eli Lilly’s international president, Patrik Jonsson. Despite uncertainty surrounding the U.S. FDA’s new fast-track review process, Jonsson expressed caution about utilizing this pathway for Orforglipron. Meanwhile, the drug’s Phase 3 ATTAIN-1 trial results were published in the New England Journal of Medicine, showing weight loss plateauing around 40 weeks. BMO Capital, Cantor Fitzgerald, and Bernstein have all reiterated their favorable ratings on Eli Lilly, with price targets set at $840, $825, and $1,000, respectively. These analyses follow the publication of the trial data, which were also presented at the European Association for the Study of Diabetes conference. The trial results indicate that while the weight loss plateaued, it remains a manageable scenario according to Bernstein. These developments highlight Eli Lilly’s strategic moves in the weight-loss drug market.
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