Eli Lilly’s Announcement Regarding Oral GLP-1 Orforglipron

• In ATTAIN-2, orforglipron met the primary and all key secondary endpoints, with compelling efficacy results and a safety profile consistent with injectable GLP-1 medicines
• Participants with obesity or overweight and type 2 diabetes, a population with increased difficulties losing weight, lost an average of 22.9 lbs (10.4kg) (10.5%) on the highest dose, with HbA1c reduced by an average of 1.8%

TOKYO, August 27, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Eli Lilly and Company (hereafter “Eli Lilly”, NYSE: LLY) issued a press release on August 26, 2025 (local time) regarding 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 HbA1c 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% (22.9 lbs (10.4kg)) compared to 2.2% (5.1 lbs (2.3kg)) with placebo using the efficacy estimand.^*

In a key secondary endpoint, orforglipron lowered HbA1c 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 HbA1c ≤6.5%, which is at or below the American Diabetes Association's definition of diabetes.¹ Additionally, orforglipron showed clinically meaningful benefits across key cardiovascular risk factors, including non-HDL cholesterol, systolic blood pressure and triglycerides.

The overall safety profile of orforglipron in ATTAIN-2 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. Treatment discontinuation rates due to adverse events were 6.1% (6 mg), 10.6% (12mg) and 10.6% (36 mg) for orforglipron vs. 4.6% with placebo. Overall treatment discontinuation rates were balanced across the treatment groups with 19.1% (6 mg), 22.3% (12 mg) and 20.5% (36 mg) for orforglipron vs. 20.0% with placebo. No hepatic safety signal was observed.

Detailed ATTAIN-2 results will be presented at a future medical meeting and published in a peer-reviewed journal.

For the full text of Eli Lilly's press release, please refer to the Latest News via the following link:
Lilly’s oral GLP-1, orforglipron, is successful in third Phase 3 trial, triggering global regulatory submissions this year for the treatment of obesity
https://investor.lilly.com/

This announcement is not expected to have an impact on Chugai's consolidated financial forecast for the fiscal year ending December 2025, which was announced on January 30, 2025.

* The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) for 72 weeks without initiating prohibited weight management treatments (and glycemic rescue therapy for glycemic endpoints only).

Sources

1. American Diabetes Association. (n.d.). Understanding diabetes diagnosis. Diabetes Diagnosis & Tests | ADA. [Internet; cited August 2025]. Available from: https://diabetes.org/about-diabetes/diagnosis