Foundayo Heart Safety Trial
Eli Lilly reports oral GLP-1 drug Foundayo matches insulin heart safety in trial
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Key Points
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ACHIEVE-4 enrolled 2,749 adults across 16 countries, most of whom had established heart disease; participants were followed for a median of about two years in an open-label trial.
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Major cardiovascular events occurred in 57 participants taking Foundayo (4.2%) and 67 taking insulin glargine (5.0%). The hazard ratio was 0.84 (95% CI, 0.59–1.20); the confidence interval crossed 1.0, so the trial did not establish a reduction in heart risk.
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In prespecified analyses, Foundayo was associated with a 23% lower risk of MACE-3—cardiovascular death, heart attack or stroke—than insulin glargine.
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At 52 weeks, participants taking Foundayo had an average 1.6 percentage-point reduction in A1C from a baseline of 8.22%, compared with a 1.0 percentage-point reduction with insulin glargine; average weight loss with Foundayo was 8.8%.
Eli Lilly's once-daily pill Foundayo matched insulin for heart safety in the largest diabetes trial to date, meeting its primary goal in the Phase 3 ACHIEVE-4 study. The Pharma Letter reported that 4.2% of Foundayo users had major cardiovascular events compared with 5.0% taking insulin glargine—a difference that was not statistically significant. The trial also showed Foundayo lowered blood sugar and weight more effectively than insulin, though fewer deaths occurred in the pill group in secondary analyses.
The results, presented at the European Association for the Study of Diabetes meeting and published in The Lancet, involved 2,749 adults with type 2 diabetes, excess weight, and high cardiovascular risk across 16 countries. Medical Daily noted the mortality findings warrant caution since they were not the trial's main focus. Foundayo remains unapproved for diabetes treatment but is already FDA-approved for chronic weight management in adults.
Trial Design and Cardiovascular Outcomes
ACHIEVE-4 followed 2,749 participants for roughly two years in an open-label trial—meaning both patients and doctors knew who got which treatment. Fierce Pharma described the study as enrolling adults with type 2 diabetes and obesity at increased cardiovascular risk. Major cardiovascular events (heart attacks, strokes, or cardiovascular death) hit 57 Foundayo users (4.2%) and 67 insulin users (5.0%).
The hazard ratio was 0.84, with a confidence interval of 0.59 to 1.20—meaning the interval crossed 1.0, so the trial did not prove Foundayo reduces heart risk. However, in a prespecified secondary analysis, Foundayo showed a 23% lower risk of cardiovascular death, heart attack, or stroke than insulin glargine, though this was not the trial's primary goal.
Blood Sugar and Weight Control Far Superior
Foundayo outperformed insulin glargine on both diabetes and weight management. At 52 weeks, Foundayo users saw their A1C—a marker of blood sugar control—drop by an average of 1.6 percentage points from a baseline of 8.22%. The insulin group saw only a 1.0 percentage point drop. Average weight loss with Foundayo was 8.8%, a substantial difference that highlights the drug's dual benefit.
Mortality Findings Require Caution and Further Study
Fewer deaths occurred among Foundayo participants in secondary analyses, but experts stress these findings need careful interpretation. Medical Daily cautioned that because mortality was not the trial's primary endpoint, these results should be viewed as exploratory, not proof that Foundayo prevents deaths. The company did not highlight exact death counts, and larger, longer studies would be needed to confirm any survival benefit.
Modeled Risk Reductions in Separate Obesity Trial
In post-hoc analyses of the ATTAIN-1 obesity trial, Market Screener reported that Foundayo reduced modeled 10-year diabetes risk by 45% to 57% and cardiovascular risk by 13% to 18%, depending on the dose used. These are estimates based on mathematical models, not actual outcomes observed in the trial. The findings suggest potential long-term benefits but do not prove Foundayo prevented diabetes or heart disease in study participants.
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