Weekly injectable GLP-1 agonist developed by Hanmi. Showed cardiovascular and kidney benefit in type 2 diabetes and in October 2026 was approved in South Korea for weight management.
Regulatory status
Not approved
Family
Long-acting GLP-1 receptor agonist
Scientific evidence
High
Number of findings
3
Where it acts
Hormones and metabolism · Heart and blood · Digestive and weight
Also known as
efpeglenatide, HM11260C, LAPS-Exendin, Efeo
Regulatory status
FDA (US): Not approved
EMA (EU): Not approved (authorized only in South Korea, 2026, for obesity or overweight without diabetes)
Dose
In the AMPLITUDE-O trial, 4 or 6 mg by weekly subcutaneous injection was used (clinical trial, PMID 34215025). In Korea, doses of 2 to 10 mg were approved; there is no dose approved by the FDA or EMA.
Safety
More diarrhea, constipation, nausea, vomiting, and abdominal bloating than with placebo. Use only with a medical prescription.
Interactions
May delay the absorption of oral drugs and increase the risk of hypoglycemia if combined with insulin or sulfonylureas.
Differences between women and men
In the Korean phase 3 obesity trial, the subgroup with the greatest weight loss was women with a BMI below 30 (−12.2% at 40 weeks), according to the company (Hanmi, 2025). In AMPLITUDE-O, 33% of participants were women.
Effect by goal · level of evidence
Fewer cardiovascular events in high-risk type 2 diabetes
reducesHighRCT (AA)in people
−27% CV events
AMPLITUDE-O with 4,076 people followed for a median of 1.8 years: 27% fewer heart attacks, strokes, or cardiovascular deaths vs placebo (HR 0.73).
Mimics the hormone GLP-1: it stimulates insulin when blood sugar rises, reduces appetite, and slows gastric emptying. It is attached to an antibody fragment that lengthens its life in the blood, which allows one dose a week.
What the evidence says
In people
Fewer cardiovascular events in high-risk type 2 diabetes. AMPLITUDE-O with 4,076 people followed for a median of 1.8 years: 27% fewer heart attacks, strokes, or cardiovascular deaths vs placebo (HR 0.73). PubMed 34215025
Kidney protection in type 2 diabetes. In the same trial, the composite of worsening kidney function was reduced by 32% (HR 0.68). The benefit was greater with 6 mg than with 4 mg. PubMed 34215025
Dose-dependent effect. Dose-based analysis of AMPLITUDE-O: 6 mg reduced major cardiovascular events by 35% (HR 0.65) and 4 mg by 18% (HR 0.82, not significant). PubMed 36802715