Weight loss pill linked to reduced risk of heart attack or stroke after FDA requested more data
Eli Lilly and Company has shared new clinical data on the cardiovascular safety of orforglipron, the company’s new GLP-1 receptor agonist pill being sold under the brand name Foundayo.
In early April, when the U.S. Food and Drug Administration (FDA) approved orforglipron for treating weight-related medical problems in obese adults, the agency requested additional data due to an “unexpected serious risk for major adverse cardiovascular events.” As an apparent response to that request, Lilly has now shared initial findings from ACHIEVE-4, a new randomized trial of more than 2,700 overweight or obese patients with type 2 diabetes.
For ACHIEVE-4, patients with type 2 diabetes were enrolled in the United States, Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain and Turkey. All participants were randomized to either undergo treatment with orforglipron or insulin glargine.
Overall, Lilly reported that orforglipron was linked to a 16% lower risk of the composite outcome of cardiovascular death, heart attack, stroke or hospitalization for unstable sudden chest pain than insulin glargine. The risk of all-cause mortality, meanwhile, was 57% lower for orforglipron. In addition, Lilly’s GLP-1 drug was linked to much larger one-year improvements in terms of A1C and body weight than insulin glargine.
“Across seven phase III studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile,” Thomas Seck, MD, senior vice president of product development for Lilly’s cardiometabolic health division, said in a prepared statement. “ACHIEVE-4 adds a new dimension to that evidence—cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk. Together with the simplicity of a once-daily pill that requires no food or water restrictions, we believe Foundayo could be an important new treatment option for people with type 2 diabetes.”
Lilly also shared more details about how patients responded to taking orforglipron. More than 10% of patients discontinued treatment, for example, due to “adverse events.” The most common incidents included nausea, vomiting, diarrhea, decreased appetite and constipation.
According to Lilly, the company plans on securing an additional FDA approval for orforglipron that will cover the treatment of patients with type 2 diabetes. These early ACHIEVE-4 findings are expected to play a critical role when it comes to securing that approval.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.