CLAIM #36989 · Eli Lilly and Company (LLY) · 2025Q1 earnings call · May 1, 2025 · due Dec 31, 2025
“Assuming success in these Phase 3 programs, we plan to submit orforglipron for obesity in Q4 later this year, followed by Type 2 diabetes in the first half of 2026.”
Dr. Dan Skovronsky · Chief Scientific Officer
In context
“cule, resulted in a tolerability profile that matched our expectations and was consistent with weekly injectable GLP-1s. The ACHIEVE-1 full results will be presented at the ADA's 85th Scientific Sessions and will be published in a peer reviewed journal. This was the first of several Phase 3 trials that we'll read out for orforglipron. On Slide 15, you can see how ACHIEVE-1 fits into the broader orforglipron development program. Over the next 12 months, we expect to get results from four additional diabetes trials, where we're studying orforglipron compared to insulin and head to head versus other oral diabetes medicines. We also expect to get results in our two obesity Phase 3 trials, one trial in people with obesity without diabetes and a second trial in people with obesity and diabetes. Assuming success in these Phase 3 programs, we plan to submit orforglipron for obesity in Q4 later this year, followed by Type 2 diabetes in the first half of 2026. We also have an ongoing Phase 3 trial in obesity in the maintenance obesity and we will initiate a Phase 3 trial in hypertension later this quarter. We look forward to seeing more data from this robust clinical development program as we continue to find the impact orforglipron can have for patients. Moving on to other R&D updates since our last call. On the regulatory front, following discussions with the FDA, we've withdrawn our U.S. application for the heart failure with preserved ejection fraction indication for Tirzepatide. We believe the positive Phase 3 data from the SUMMIT trial do support an indication. However, FDA indicated an additional confirmatory clinical trial is required. Regulatory reviews are ongoing in other countries. Continuing with updates in Cardiometabolic Health,”
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SEC filings for LLY ↗ · Claim quote is verbatim from the 2025Q1 earnings call.