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# Trial Success for Lilly Oral GLP-1
- URL: https://www.fdaweb.com/trial-success-for-lilly-oral-glp-1/
- Published: 2025-10-15T12:00:00.000Z
- Updated: 2026-09-14T15:24:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160042

Lilly says its oral GLP-1 investigational drug orforglipron demonstrated superior glycemic control in the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. A company [statement](https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-superior-glycemic?ref=fdaweb.com) says ACHIEVE-2 was the second head-to-head trial that evaluated orforglipron versus dapagliflozin (AstraZeneca’s Farxiga), an SGLT-2 inhibitor, in adults with Type 2 diabetes inadequately controlled on metformin. ACHIEVE-5 evaluated orforglipron versus placebo in adults with Type 2 diabetes and inadequate glycemic control with titrated insulin glargine, with or without metformin and/or SGLT-2 inhibitors.

The company says that in both trials, the overall safety and tolerability profile of orforglipron and treatment discontinuation rates were consistent with earlier studies.

The most common adverse events were gastrointestinal-related and generally mild to moderate in severity, the statement says. No hepatic safety signal was seen.

Orforglipron is described as a once-daily small molecule oral glucagon-like peptide 1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.

Lilly says it is running Phase 3 studies on the drug to treat Type 2 diabetes and for use in weight management in adults with obesity or overweight with at least one weight-related medical problem. It also is being studied as a potential treatment for obstructive sleep apnea, hypertension, and osteoarthritis pain in adults with obesity, Lilly says.