NEW DELHI, August 26, 2025 -- Eli Lilly and Company today announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron, an investigational oral GLP-1 receptor agonist, in adults with obesity or overweight and type 2 diabetes. In the trial, all three doses of orforglipron met the primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks. For the primary endpoint, orforglipron 36 mg, taken once per day without food and water restrictions, lowered weight by an average of 10.5% (10.4 kg) compared to 2.2% (2.3 kg) with placebo using the efficacy estimand.1 With the completion of ATTAIN-2, Lilly now has the full clinical data package required to initiate global regulatory submissions for orforglipron.

“Based on my experience leading clinical trials in obesity and diabetes, these data show the potential for orforglipron to offer an efficacy, safety, and tolerability profile consistent with the injectable GLP-1 class," said Louis J. Aronne, MD, FACP, DABOM, founder and Chair Emeritus of the American Board of Obesity Medicine, former president of The Obesity Society, Fellow of the American College of Physicians, and world-renowned obesity specialist. "Orforglipron could help health care providers expand treatment options for patients who prefer oral therapies without compromising clinical results.”

In the ATTAIN-2 trial, orforglipron met the primary endpoint of superior body weight reduction compared to placebo. Participants taking the highest dose of orforglipron lost an average of 10.4 kg (10.5%) at 72 weeks using the efficacy estimand. In a key secondary endpoint, orforglipron lowered A1C by 1.3% to 1.8% from a baseline of 8.1% across doses. In another key secondary endpoint, 75% of participants taking the highest dose of orforglipron achieved an A1C ≤ 6.5%, which is at or below the American Diabetes Association's definition of diabetes.2 Additionally, orforglipron showed clinically meaningful benefits across key cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure and triglycerides. In a pre-specified exploratory analysis, the highest dose of orforglipron reduced high-sensitivity C-reactive protein (hsCRP) levels, a marker of inflammation, by 50.6%.

Efficacy Estimand Results

Orforglipron 6mg

Orforglipron 12 mg

Orforglipron 36mg

Placebo

Primary Endpoint

Mean percent change in body weight from avg. baseline (101.4 kg)i

-5.5%

(-5.5 kg)

-7.8%

(-7.9 kg)

-10.5%

(-10.4 kg)

-2.2%

(-2.3 kg)

Key Secondary Endpoints

Percentage of participants achieving body weight reductions

of ≥10%i

23.9%

35.5%

50.1%

7.0%

Percentage of participants achieving body weight reductions of ≥15%ii

7.3%

17.7%

28.4%

1.9%

A1C reduction from avg.

baseline of 8.1%i

-1.3%

-1.6%

-1.8%

-0.1%

Percentage of

participants achieving A1C