By VETTAPHARMA reporter – Derek Roche: Eli Lilly’s Foundayo (orforglipron) demonstrated clinically meaningful weight loss in adults 65 years and older in a post‑hoc analysis of the Phase 3 ATTAIN‑1 and ATTAIN‑2 trials, the company reported May 22, 2026. At the highest approved dose (17.2 mg), older participants in ATTAIN‑1 (without type 2 diabetes) showed a 13.0% mean body‑weight reduction at 72 weeks versus 1.6% with placebo; comparable reductions were observed across lower doses and in ATTAIN‑2 (with type 2 diabetes), where the 17.2 mg group recorded 12.2% mean weight loss. The analysis pooled safety data and separated efficacy by age subgroup.
Trial context and design: ATTAIN‑1 enrolled 3,127 adults (195 aged ≥65) without pre‑existing type 2 diabetes; ATTAIN‑2 enrolled 1,613 adults (418 aged ≥65) with type 2 diabetes. Both were randomized, double‑blind, placebo‑controlled studies of three once‑daily oral doses of orforglipron (5.5 mg, 9 mg, 17.2 mg) over 72 weeks, combined with diet and activity guidance. The post‑hoc analysis presented at ECO 2026 examined percent change in body weight at Week 72 using the efficacy estimand and treated the age subgroups as exploratory, hypothesis‑generating findings.
Safety and tolerability: The safety profile in older adults aligned with the broader ATTAIN populations. Gastrointestinal adverse events—nausea, constipation, diarrhea, vomiting—were the most frequent class effects. Pooled serious adverse event (SAE) rates in participants ≥65 were 9.9% (5.5 mg), 13.0% (9 mg), and 11.6% (17.2 mg) versus 11.4% for placebo. Lilly noted these findings are consistent with known GLP‑1 receptor agonist class effects and emphasized the need to weigh benefit and risk in older patients.
Access and policy note: Lilly highlighted that starting July 1, 2026, Medicare beneficiaries can access Foundayo through the Medicare GLP‑1 Bridge program at a $50 monthly copay, a development that could materially affect affordability and uptake among older adults in the U.S. The company also reiterated label warnings including potential thyroid tumors, pancreatitis, gallbladder events, and interactions affecting oral contraceptives.
Clinical and commercial implications: As the only approved oral, non‑peptide GLP‑1 receptor agonist that can be taken with or without food, Foundayo’s demonstrated efficacy in older adults supports its positioning for broad adult populations, including those with and without type 2 diabetes. The 8–13% weight‑loss range at 72 weeks across doses strengthens Lilly’s obesity portfolio and may influence payer discussions, especially given the Medicare access pathway and the product’s oral dosing convenience for older patients.
