Efpeglenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist, the same drug class as semaglutide and exenatide. It is given once a week by subcutaneous injection. The molecule is built differently from most peptide GLP-1 drugs: it is a modified version of exendin-4 (the same starting point as exenatide) joined through a flexible linker to an IgG4 Fc fragment. That Fc attachment slows breakdown and renal clearance and stretches the dosing interval, which is why early development described a once-weekly, and at one point once-monthly, schedule (Gerstein et al., NEJM 2021; AdisInsight).
The compound originated at South Korea's Hanmi Pharmaceutical, which has carried it under the code HM11260C. Sanofi licensed it, ran late-stage trials, and then returned the rights to Hanmi.
What the research shows
The standout study is AMPLITUDE-O, a cardiovascular outcomes trial published in the New England Journal of Medicine in 2021 (PMID 34215025). It enrolled 4,076 people with type 2 diabetes who already had cardiovascular disease, or kidney disease plus another risk factor. Participants were randomized to weekly efpeglenatide (4 mg or 6 mg) or placebo and followed for a median of about 1.8 years.
The results were positive on the endpoints that matter most in this population:
- The primary outcome of cardiovascular death, heart attack, or stroke occurred in 7.0% of the efpeglenatide group versus 9.2% on placebo, a 27% relative reduction.
- A composite kidney outcome (worsening kidney function or new macroalbuminuria) occurred in 13.0% versus 18.4% with placebo.
- Benefits followed a dose-response pattern, with the 6 mg dose doing more than the 4 mg dose, and appeared regardless of whether people were also taking an SGLT2 inhibitor (American College of Cardiology summary).
This made efpeglenatide one of the few GLP-1 agonists with documented cardiovascular and renal benefit, and notable as the first such result for an exendin-based agent. Gastrointestinal side effects (nausea, diarrhea, vomiting) were more common than with placebo, which is typical for the class.
Where it stands now
Efpeglenatide is not an approved medicine. After Sanofi handed it back, Hanmi repositioned it toward weight management. The company has run Phase 3 obesity trials sized for Korean patients with overweight or early-stage obesity, and Korea's Ministry of Food and Drug Safety granted it fast-track review. Reported timelines point to trial completion around 2026 and a possible launch as the country's first homegrown GLP-1 obesity drug after that (KED Global). As of this writing it has no FDA or EMA approval, and there is no WADA-specific prohibition tied to this individual compound; GLP-1 agonists are not on the prohibited list.
The buyer's-eye view
Because efpeglenatide is investigational, anything sold under this name through research-chemical channels is unapproved and labeled research-use-only, not for human consumption. That raises the usual quality questions an information aggregator can flag but not resolve: a vendor should be able to show a third-party certificate of analysis confirming identity and purity for the specific lot, and independent testing matters more, not less, for a Fc-conjugated peptide that is harder to make than a short linear chain. We aggregate vendor and testing signals where they exist, but published independent COA data on grey-market efpeglenatide is sparse.
Nothing here is medical, dosing, or efficacy advice. The trial figures above describe a controlled clinical study of a specific formulation and dose, not a product sold online.
Sources: [Gerstein HC et al., NEJM 2021 (AMPLITUDE-O)](https://www.nejm.org/doi/full/10.1056/NEJMoa2108269); [PubMed PMID 34215025](https://pubmed.ncbi.nlm.nih.gov/34215025/); [American College of Cardiology trial summary](https://www.acc.org/latest-in-cardiology/clinical-trials/2021/07/12/18/03/amplitude-o); [AdisInsight drug record](https://adisinsight.springer.com/drugs/800031952); [KED Global on Hanmi's obesity program](https://www.kedglobal.com/bio-pharma/newsView/ked202411210009).