Key insights
- Eli Lilly's Foundayo (orforglipron) demonstrated non-inferiority for cardiovascular safety in a Phase 3 trial for type 2 diabetes and obesity. The oral GLP-1 receptor agonist showed a lower risk of major adverse cardiovascular events (MACE-4) and death compared to insulin glargine. Foundayo also achieved greater reductions in A1C and body weight. While common gastrointestinal side effects were noted, the results suggest a significant positive development for the company's diabetes and obesity drug pipeline.
INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY) announced results from its Phase 3 ACHIEVE-4 trial evaluating Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk, according to a press release statement.
The trial, which enrolled 2,749 participants across 16 countries, met its primary objective of demonstrating non-inferiority for cardiovascular safety. Participants taking Foundayo experienced a 16% lower risk of MACE-4, which includes cardiovascular death, heart attack, stroke, or hospitalization for unstable chest pain, compared to insulin glargine (hazard ratio:0.84; 95.0% CI:0.59 to 1.20).
The risk of MACE-3, comprising cardiovascular death, heart attack, or stroke, was 23% lower for Foundayo versus insulin glargine (hazard ratio:0.77; 95.0% CI:0.52 to 1.13). In pre-planned analyses, cardiovascular death risk was 53% lower and all-cause death risk was 57% lower for Foundayo compared to insulin glargine.
At 52 weeks, participants treated with Foundayo showed a mean A1C reduction of 1.6% from a baseline of 8.22%, compared to 1.0% for insulin glargine. Body weight decreased by 8.8% with Foundayo versus an increase of 1.7% with insulin glargine from a mean baseline of 90.9 kg.
At 104 weeks, 54.6% of Foundayo participants achieved an A1C of 6.5% or lower, compared to 23.8% in the insulin glargine group. Weight reduction of 10% or more was achieved by 35.9% of Foundayo participants versus 3.4% with insulin glargine.
The most common adverse events for Foundayo were nausea, vomiting, diarrhea, decreased appetite, and constipation. During the 52-week minimum treatment period, 10.6% of participants discontinued Foundayo due to adverse events.
Results were presented Tuesday at the European Association for the Study of Diabetes meeting in Milan and published in The Lancet. Foundayo is an oral GLP-1 receptor agonist taken once daily.
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