Lilly oral GLP‑1 posts strong Phase III result

ATTAIN‑1 was a 72‑week, randomized, double‑blind Phase III that enrolled 3,127 adults and randomized participants 3:3:3:4 to once‑daily oral orforglipron (6 mg, 12 mg, 36 mg) or placebo as an adjunct to diet and activity. (nejm.org) In the trial’s key responder analyses, 54.6% of participants on the highest dose achieved ≥10% weight loss, 36.0% achieved ≥15%, and 18.4% achieved ≥20%, versus 12.9%, 5.9% and 2.8% in the placebo arm. (nejm.org) Safety data from the same publication showed adverse‑event discontinuations ranged from 5.3% to 10.3% across active doses versus 2.7% with placebo, with gastrointestinal events the most frequent complaints and broad cardiometabolic markers (non‑HDL cholesterol, systolic blood pressure, triglycerides) improving on therapy. (nejm.org) Lilly ran parallel Phase III programs in people with type 2 diabetes (ATTAIN‑2 and ACHIEVE trials), with ATTAIN‑2 enrolling roughly 1,600 patients and showing dose‑dependent weight and A1C benefits, and ACHIEVE‑1 reporting A1C reductions of about 1.3–1.6% and ~7.9% weight loss at the highest dose by week 40. (clinicaltrials.gov) (prnewswire.com) Lilly publicly signaled plans to file for regulatory review and built pre‑launch inventory; the company’s NDA filing was accepted and the FDA later shifted the target action date into Q2 2026, with reports showing roughly $1.5 billion in prelaunch stockpile ahead of the agency decision. (prnewswire.com) (marketscreener.com) (investing.com) Industry entrants and incumbents are already expanding GLP‑1 development into addiction medicine: Baseline Therapeutics launched with BT‑001 and announced FDA‑aligned plans for two Phase III trials in alcohol use disorder in 2026, while Lilly has publicly explored GLP‑1 programmes for substance‑use indications. (baseline-tx.com) (biospace.com)