LLY's Oral GLP-1 Pill Scores Another Pair of Diabetes Wins

Eli Lilly LLY announced positive top-line data from two late-stage studies evaluating orforglipron, its once-daily oral GLP-1 pill, in patients with type II diabetes (T2D).

The ACHIEVE-2 study compared three doses of orforglipron (3 mg, 12 mg and 36 mg) against AstraZeneca’s AZN blockbuster SGLT-2 inhibitor Farxiga (dapagliflozin) in adults with T2D inadequately controlled with metformin. The study met its primary endpoint — patients treated with orforglipron achieved superior reductions in A1C compared to AstraZeneca’s Farxiga. At 40 weeks, orforglipron lowered A1C by an average of 1.3% (3 mg) and 1.7% (12 mg and 36 mg) compared with 0.8% for Farxiga.

The ACHIEVE-5 study assessed the same three doses of orforglipron against placebo in adults with T2D and inadequate glycemic control when taken together with insulin glargine. This study also met its primary endpoint — patients treated with orforglipron achieved superior reductions in A1C compared to those on placebo. After 40 weeks, orforglipron lowered A1C by an average of 1.5% (3 mg), 2.1% (12 mg) and 1.9% (36 mg) versus 0.8% for placebo.

Lilly also mentioned that it met all the key secondary endpoints across both studies. Though the company did not share any data supporting these claims, it stated that patients treated with orforglipron achieved significant weight loss and showed improvements across multiple cardiovascular risk factors. Lilly plans to present detailed data from both studies at a future medical meeting and publish the same in a peer-reviewed journal.

Lilly Eyes 2026 Submission for Orforglipron in T2D

These latest results underscore Lilly’s success in four of the five phase III studies evaluating orforglipron in the T2D indication. Last month, Lilly reported top-line data from a late-stage, head-to-head study called ACHIEVE-3, which pitted orforglipron against Novo Nordisk’s NVO Rybelsus (oral semaglutide) in patients with T2D inadequately controlled with metformin. Results from the study showed that orforglipron lowered A1C and weight more effectively than Novo Nordisk’s Rybelsus. Similar results were also observed in the phase III ACHIEVE-1 study, which compared orforglipron to placebo in adults with T2D and inadequate glycemic control with diet and exercise alone.

Data from the phase III ATTAIN-4 study — the final global registration study in the ACHIEVE program — is expected in the first quarter of 2026. If data from this study is also positive, Lilly intends to submit regulatory filings for orforglipron in the T2D indication next year.

LLY Stock's Performance

Year to date, shares of Eli Lilly have gained 7% compared with the industry‘s 5% growth.

Lilly to Seek Orforglipron Approval in Obesity This Year

Apart from T2D, Lilly has also conducted a late-stage clinical program evaluating orforglipron for obesity patients. This program, called ATTAIN, consists of two phase III studies — ATTAIN-1 and ATTAIN-2. While the ATTAIN-1 study enrolled obese adults with at least one weight-related co-morbid condition and without T2D, the ATTAIN-2 study was conducted in overweight and obese people with T2D. Both studies achieved their primary endpoint of superior body weight reduction compared to placebo, without any food or water restrictions.

Based on these results, Lilly plans to file regulatory applications for orforglipron in obesity later this year, setting up the timeline for a potential launch in 2026. If approved, GLP-1 therapies could offer a differentiated mechanism of action that is more effective compared to existing diabetes treatments. An oral GLP-1 pill like orforglipron could offer a more convenient alternative to injectable GLP-1 therapies for patients with diabetes and obesity, currently marketed by Lilly and Novo Nordisk.

Eli Lilly and Company Price

 

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LLY’s Zacks Rank

Eli Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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