Lilly’s Orforglipron Study Proves Cardiovascular Safety, Boosts Cardiometabolic Health
Eli Lilly and Company has announced promising results from its Phase 3 trial, ACHIEVE-4, which assesses the cardiovascular safety and overall health benefits of Foundayo (orforglipron) for adults with type 2 diabetes. Conducted among more than 2,700 participants across 15 countries, this study is significant for evaluating Foundayo against insulin glargine in patients who are overweight or have obesity and face increased cardiovascular risks.
Key Findings of the ACHIEVE-4 Trial
ACHIEVE-4 successfully met its primary endpoint, demonstrating that Foundayo has a non-inferior risk of major adverse cardiovascular events (MACE-4) compared to insulin glargine. The trial showed a 16% lower risk of MACE-4 events, which include cardiovascular death, heart attack, and stroke, highlighting its potential cardiovascular safety.
Additionally, a noteworthy aspect of the results was the observed 57% reduction in the risk of all-cause mortality for those taking Foundayo compared to insulin glargine. This significant finding underlines the treatment’s promise in enhancing cardiometabolic health among diabetic patients.
Improvement in Health Metrics
- A1C Reduction: Foundayo demonstrated a reduction in A1C levels by 1.6% after 52 weeks, outperforming insulin glargine, which achieved a 1.0% reduction.
- Weight Management: Participants taking Foundayo experienced an average weight loss of 8.8%, while insulin glargine users experienced a slight weight gain of 1.7%.
The treatment effects were sustained beyond the 52-week period, reaffirming Foundayo’s robust efficacy. Dr. Thomas Seck, Senior Vice President of Product Development at Lilly, stated that these outcomes contribute to the growing evidence of Foundayo’s safety and efficacy.
Regulatory Plans and Future Studies
Following these positive results, Lilly intends to submit Foundayo for FDA approval by the end of the second quarter of 2026. This submission follows extensive evaluation through seven Phase 3 trials that included over 11,000 patients.
Important Considerations
Common side effects of Foundayo include nausea, vomiting, and decreased appetite. Lily’s trials have so far indicated a safety profile consistent with previous studies of the GLP-1 class, and no hepatic safety signals were detected during the trial period.
As part of ongoing research, Foundayo is also being evaluated for additional indications, including obstructive sleep apnea and hypertension. Lilly remains committed to addressing cardiometabolic health challenges through innovation and comprehensive clinical studies.
Overall, the findings from the ACHIEVE-4 trial not only suggest cardiovascular safety for Foundayo but also signal its potential as a new therapeutic option for individuals with type 2 diabetes, further establishing its role in enhancing overall health outcomes.
