Eli Lilly (Eli Lilly, ticker: LLY) announced on June 9 that its oral GLP-1 drug Foundayo (orforglion) outperformed competing therapies in three late-stage clinical trials in terms of blood sugar control and weight loss in patients with type 2 diabetes, with LLY’s stock price rising by about 2% at the close that day.
Confirmed data from three trials: blood sugar reduction and weight loss comparisons
According to Eli Lilly’s official announcement, the confirmed data from the three trials are as follows:
Trial 1 (vs. semaglutide): The 17.2 mg dose of Foundayo lowered blood sugar levels from a baseline of 8.3% by 2.2 percentage points, statistically significantly better than oral semaglutide 14 mg (Novo Nordisk).
Trial 2 (vs. dapagliflozin): The highest dose of Foundayo reduced blood sugar levels by 1.7 percentage points, while dapagliflozin (AstraZeneca) reduced them by 0.8 percentage points; the weight loss rate was 7.3% for Foundayo and 3.0% for dapagliflozin.
Trial 3 (vs. insulin glargine plus placebo): After adding Foundayo to insulin glargine, blood sugar levels fell by 2.1 percentage points, while the insulin plus placebo group fell by 0.8 percentage points; the Foundayo group’s weight loss was 6.1%, while the insulin plus placebo group’s weight slightly increased.
The safety data across the three trials were consistent. The most common adverse events were mild to moderate gastrointestinal issues; the proportion of patients who discontinued due to side effects remained between 12% and 50%. Eli Lilly confirmed that this is consistent with other oral GLP-1 drugs.
FAQ
What are the main differences between Foundayo and injectable GLP-1 drugs (such as Ozempic)?
According to Eli Lilly’s official description, Foundayo is an oral tablet taken once daily, which can be taken at any time during the day without restrictions on meals or drinking water, and does not require injections. This is Foundayo’s core differentiation advantage over existing injectable GLP-1 drugs (such as Ozempic), and Seck clearly lists convenience of taking the medication as an important consideration for the target patient population.
If Foundayo beats semaglutide in diabetes trials, does that mean Foundayo is definitely more effective than Wegovy or Ozempic?
The comparator in the trial was oral semaglutide 14 mg, not injectable semaglutide (Ozempic/Wegovy are administered via injection). Eli Lilly’s trial design and this announcement are based on direct comparisons of the oral formulation; positive head-to-head data between injectable semaglutide and Foundayo were not disclosed in this announcement.
When is the FDA approval expected for Eli Lilly’s application planned for submission by the end of Q2?
Eli Lilly’s official announcement confirms that it plans to submit its marketing application for Foundayo for type 2 diabetes to the FDA by the end of Q2 2026 (i.e., before the end of June 2026). The approval timeline depends on the FDA’s review process, and Eli Lilly did not disclose the expected approval date in this announcement.
