Efpeglenatide
Also known as: LY3434285
An exendin-4-based GLP-1 receptor agonist conjugated to an antibody Fc fragment that slows clearance and activates the GLP-1 receptor to boost glucose-dependent insulin secretion, slow gastric emptying and reduce appetite.
- Drug class
- GLP-1 receptor agonist (exendin-4-based)
- Primary targets
- GLP-1 receptor
- Dose reference
- Studied in trials at 4 mg or 6 mg once weekly subcutaneously (also 2 mg in dose-ranging); reference ranges from research only, not a recommendation or approved dose.
- Half-life
- Approximately 5.6 to 7.5 days (single-ascending-dose pharmacokinetic studies)
- Developer / origin
- Hanmi Pharmaceutical (South Korea); licensed to and trialed by Sanofi, rights returned 2020
- Reference year
- 2021
- Evidence score
- 4/5 - Strong trial evidence but investigational
Strong trial evidence but investigational
Efpeglenatide has genuine phase 3 outcomes evidence: the AMPLITUDE-O trial (NEJM 2021, n=4076) showed weekly subcutaneous dosing reduced major adverse cardiovascular events (7.0% vs 9.2% placebo) and a composite kidney outcome (13.0% vs 18.4%) in high-risk type 2 diabetes, with supporting glycemic and weight data from the broader AMPLITUDE program. However, development was halted by the original sponsor and the agent has no marketing approval.
Investigational compound with human randomized or phase 2/3 evidence.
Evidence basis
- Randomized, double-blind, placebo-controlled cardiovascular outcomes trial (AMPLITUDE-O, 4076 patients, 28 countries)
- Multiple phase 2/3 randomized controlled trials in the AMPLITUDE program (M, D, L, S) and a phase 2 study in adults without diabetes
- Published pharmacokinetic and dose-finding studies
- Limitation: single-sponsor program halted for business reasons; no regulatory approval and no real-world post-marketing data
Key references
- New England Journal of MedicineCardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes
- ClinicalTrials.govEffect of Efpeglenatide on Cardiovascular Outcomes (AMPLITUDE-O), NCT03496298
- Diabetes Care / PMCEfficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial
How to read this entry
Dose references and half-life values are pulled from trial protocols, labels, reviews, or published summaries where available. They are context for research and comparison, not a personal dosing recommendation.
Status matters: approved drugs have regulated indications; investigational compounds are still being studied; research-only peptides do not have established human dosing, safety, or efficacy for consumer use.
Efpeglenatide guides
Read the matching guide or adjacent research pages for more context.
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