GLP-1 agonist · weight management
Efpeglenatide is a long-acting GLP-1 receptor agonist developed by Hanmi Pharmaceutical. It is a modified exendin peptide chemically linked to an antibody Fc fragment. After its diabetes program with Sanofi was stopped early for funding reasons, Hanmi developed it for obesity, and South Korea approved it in October 2026 for chronic weight management.
Efpeglenatide's active part is an exendin analog with a single amino-acid change. Exendin-based peptides activate the GLP-1 receptor, the target of the gut hormone that raises insulin release when glucose is high, lowers glucagon, slows stomach emptying and reduces appetite. The peptide is joined through a short polyethylene glycol linker to the Fc region of human IgG4. That Fc conjugation slows its removal from the body: an early single-ascending-dose study in type 2 diabetes measured a half-life of about 5.6 to 7.5 days4. Exendin-based drugs often provoke antibodies; in a phase 2 obesity trial, 21.7% of participants treated with efpeglenatide developed them4.
In AMPLITUDE-O, 4,076 people with type 2 diabetes and cardiovascular or kidney disease were randomized to efpeglenatide or placebo; over a median 1.8 years, major cardiovascular events occurred in 7.0% versus 9.2% (hazard ratio 0.73) and a composite kidney outcome in 13.0% versus 18.4%1. Results looked similar with or without SGLT2 inhibitors2. Three glucose-lowering phase 3 trials were stopped early by the sponsor for funding reasons rather than concerns about harms or efficacy; in one, HbA1c lowering was noninferior to dulaglutide3.
In a 20-week phase 2 trial in adults with obesity but no diabetes, weight fell about 6 to 7 kg more than with placebo4. In the Korean phase 3 trial behind its approval, 448 Korean adults without diabetes lost 9.0% of body weight at 40 weeks versus 0.9% on placebo5. A Korean diabetes trial began recruiting in 20266.
South Korea's national drug regulator, the MFDS, approved efpeglenatide on 7 October 2026 for chronic weight management, alongside a reduced-calorie diet and exercise, in adults without diabetes who have obesity or are overweight with a weight-related condition. It is not approved by the FDA.
In the Korean obesity trial, the most frequent reactions were diarrhea (18% vs 5% on placebo), nausea, indigestion, constipation, injection-site reactions, vomiting and lowered blood sugar; gallstones occurred in 1.4% over 64 weeks5. The Korean label warns of thyroid C-cell tumors seen in rodents and rules out use with a personal or family history of medullary thyroid carcinoma or MEN 25. Injection-site reactions were more common in people who developed antibodies. Heart rate rose by about 7 beats per minute on average, with no change on placebo5.
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