GLP-1 Daily: Ozempic & Wegovy News
Lilly's Oral GLP-1 Orforglipron Clears Heart-Safety Bar in ACHIEVE-4
Friday, October 9, 2026 · 6 min
Eli Lilly's once-daily oral GLP-1 orforglipron showed no excess cardiovascular risk against insulin glargine in the 2,749-patient ACHIEVE-4 trial, published in The Lancet. That clears a key regulatory hurdle, while an NEJM perspective warns that obesity drug trials aren't built to detect emerging harms.
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Show notes
Eli Lilly's once-daily oral GLP-1 orforglipron showed no excess cardiovascular risk against insulin glargine in the 2,749-patient ACHIEVE-4 trial, published in The Lancet. That clears a key regulatory hurdle, while an NEJM perspective warns that obesity drug trials aren't built to detect emerging harms.
In this episode
- Step Back — With the FDA warning Empower Pharmacy over what it calls an “inordinate” number of copies of weight-loss drugs, how does the agency distinguish lawful compounding for individual patients from an impermissible copy—and what should patients ask their prescriber or pharmacy to understand which kind they’re receiving?
Background sources
- Will an FDA crackdown curb access to cheaper GLP-1 weight-loss drugs? Here's what to know. - CBS News — Cbsnews
- FDA Warning Letter to Empower Pharmacy and What It Means for 503A Compounding Pharmacies | Buchanan Ingersoll & Rooney PC — ,
- FDA Warning Letter Targets Compounded GLP-1 Products — Edgar J. Asebey, Guilherme Ferrari Faviero
- FDA Warning Letter To Empower Pharmacy And What It Means For 503A Compounding Pharmacies - Healthcare - United States — Lucas Morgan
- Empower, the B Vitamin, and the Word “Pretextual” — Lumalexlaw
- FDA Warning Letter Questions “Significant Difference” Documentation for Compounded GLP-1s | Spakinect — Paulina Riedler, RN
- Major trial confirms CVD safety of oral GLP‑1RA — The Limbic
“The once-daily oral GLP-1RA orforglipron does not show any excess cardiovascular risks when compared with insulin glargine for patients with type 2 diabetes, data presented at the European Association for the Study of Diabetes 2026 meeting has shown. Highly anticipated results…”
- NEJM Interview: Sarah Schmitz on protections for people enrolled in trials of investigational agents for obesity. — Exa
“So trials of obesity pharmacotherapies have largely been designed with change in BMI as the primary endpoint and a goal of maximizing weight loss. So my concern is that these trials aren't built to detect the harms that have become more likely as obesity pharmacotherapy is…”