Lilly’s Foundayo outperformed existing treatments on blood sugar control and weight loss in type 2 diabetes patients in three late-stage trials.
- Foundayo is already approved by the FDA for obesity.
- Lilly said it plans to submit Foundayo for U.S. regulatory approval for type 2 diabetes by the end of the second quarter.
- It is expected to expand Lilly’s total addressable market, allowing ease of use for patients.
Shares of Eli Lilly and Company (LLY) closed about 2% higher on Monday and edged up after-hours after the company reported that its oral GLP-1 pill Foundayo (orforglipron) outperformed existing treatments on blood sugar control and weight loss in type 2 diabetes patients in three late-stage trials.
The positive share price reaction reflected Wall Street’s view that the once-daily tablet — already FDA-approved earlier this year for obesity and overweight — is on track to become a major player in type 2 diabetes treatment as well.
Trial Results
In three trials, Foundayo delivered superior blood sugar level reductions versus rival drugmaker Novo Nordisk’s semaglutide, AstraZeneca’s dapagliflozin, and placebo.
In one of the trials that compared the drug with semaglutide, the 17.2 mg dose of Foundayo reduced blood sugar levels by 2.2 percentage points from a baseline of 8.3% — beating oral semaglutide 14 mg by a statistically significant margin.
In the trial that pitted Foundayo against dapagliflozin, the highest dose of Foundayo reduced blood sugar levels by up to 1.7 percentage points versus 0.8 points for dapagliflozin, with 7.3% weight loss versus 3.0%
In the third trial, which tested Foundayo on top of insulin glargine, blood sugar levels dropped up to 2.1 points versus 0.8 points for placebo plus insulin, with 6.1% weight loss versus a slight gain.
Safety data were consistent across the three trials. The most common side effects were mild-to-moderate gastrointestinal issues. Discontinuation rates due to side effects stayed in the low-to-mid teens, in line with other oral GLP-1s, Lilly said.
Trial Takeaway And Regulatory Process
Lilly executive Thomas Seck, senior vice president of cardiometabolic product development, said the results position Foundayo as a potential first-line oral option for millions of type 2 diabetes patients who prefer a convenient pill taken any time of day, with or without food or water.
Lilly said it plans to submit Foundayo for U.S. regulatory approval for type 2 diabetes by the end of the second quarter. The drug was already approved earlier this year for obesity and overweight with related conditions, effectively expanding the company’s total addressable market with the addition of an oral alternative to injectable GLP-1 drugs.
How Did LLY Retail Traders React?
On Stocktwits, retail sentiment around LLY stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
A Stocktwits user drew a parallel between LLY and its rival NVO stock, noting that LLY is trading at a much higher price-to-earnings ratio compared to Novo.
LLY stock has gained about 49% over the past 12 months.
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