Eli Lilly releases topline data for new oral GLP-1

Eli Lilly and Company has announced positive topline results for the first oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase III trial. 

“ACHIEVE-1 is the first of seven Phase III studies examining the safety and efficacy of orforglipron across people with diabetes and obesity. We are pleased to see that our latest incretin medicine meets our expectations for safety and tolerability, glucose control and weight loss, and we look forward to additional data readouts later this year,” remarked David Ricks, Eli Lilly Chair and CEO.

Data highlights from the ACHIEVE-1 Phase III trial for Eli Lilly’s GLP-1

At 40 weeks, Eli Lilly’s orforglipron enabled a superior reduction in A1C compared to placebo. Specifically, it reduced A1C by an average of 1.3 percent to 1.6 percent from a baseline of 8.0 percent. This is based on the efficacy estimand applied to the trial data.

Over 65 percent of participants given the highest orforglipron dose attained an A1C level less than or equal to 6.5 percent. This demonstrates promising potential for patients, as seven percent is regarded as the diabetes threshold by the American Diabetes Association’s (ADA).

In the same dosage group, further data showed that these participants lost an average of 16.0 lbs (7.9 percent).

Despite these positive findings, “one caveat is that we do not know the effects of this newer therapy on cardiovascular outcomes but this will be forthcoming in future trials. It is also good to hear about the safety profile of these new oral GLP-1RA drugs – especially the liver results – and it will be good to see the data in a full publication in due course,” Professor Naveed Sattar, Professor of Cardiometabolic Medicine/Honorary Consultant, University of Glasgow shared.

Results from Eli Lilly’s Phase III study for the GLP-1 are being presented at the ADA’s 85th Scientific Sessions in June and additionally published in a journal. Findings from the ATTAIN Phase III clinical trial programme investigating orforglipron as a tool for weight management will be shared later in 2025.

Eli Lilly anticipates regulatory submissions by the end of this year for orforglipron as a once-daily weight management medicine. Submission for the use of the drug to treat type 2 diabetes is expected next year.