Weight & metabolic
Efpeglenatide
LAPS-Exendin4
Efpeglenatide is a long-acting exendin-based GLP-1 receptor agonist fused to an antibody Fc fragment, developed by Hanmi and later Sanofi. It is best known for the AMPLITUDE-O cardiovascular outcomes trial. It is not FDA approved.
Also known as: HM11260C
- Status
- Efpeglenatide is in Phase 3 clinical trials and not approved.
- Evidence
- Human trials. Published clinical trials in people report results.
- Half-life
- Consistent with weekly dosing; extended by Fc fusion.
- How it's taken
- Weekly subcutaneous injection (investigational)
- Mechanism
- Incretin (GLP-1 / GIP / glucagon / amylin)
- Pathways
- GLP-1
How Efpeglenatide works
Efpeglenatide is an exendin-4 analogue linked to an immunoglobulin Fc fragment, which extends its half-life by reducing renal clearance and engaging FcRn-mediated recycling. Pharmacologically it is a conventional GLP-1 receptor agonist: glucose-dependent insulin secretion, glucagon suppression, delayed gastric emptying and reduced appetite.
What research has looked at
- The AMPLITUDE-O trial reported a reduction in major adverse cardiovascular events in people with type 2 diabetes and either established cardiovascular disease or kidney disease with risk factors.
- The same trial reported a reduction in a composite kidney outcome, adding to evidence for renal benefit across the GLP-1 class.
- The cardiovascular benefit was observed in a population with a high proportion of participants already on SGLT2 inhibitors, suggesting the effects are at least partly additive.
Evidence level: Human trials. Published clinical trials in people report results. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Gastrointestinal effects characteristic of the GLP-1 class — nausea, vomiting, diarrhea.
- Exendin-based GLP-1 agonists carry a higher rate of anti-drug antibody formation than human GLP-1-based agents such as semaglutide.
- Increased heart rate, as with the class.
- It is not approved by any major regulator and development has not resulted in a marketed product; long-term safety outside trials is not characterised.
Sources
- PubMed research on efpeglenatide AMPLITUDE-O cardiovascular · NIH · National Library of Medicine
- DrugBank record for efpeglenatide · DrugBank
- Active clinical trials for efpeglenatide · U.S. National Library of Medicine
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Efpeglenatide FAQ
What is Efpeglenatide?
Efpeglenatide is a long-acting exendin-based GLP-1 receptor agonist fused to an antibody Fc fragment, developed by Hanmi and later Sanofi. It is best known for the AMPLITUDE-O cardiovascular outcomes trial. It is not FDA approved.
How does Efpeglenatide work?
Efpeglenatide is an exendin-4 analogue linked to an immunoglobulin Fc fragment, which extends its half-life by reducing renal clearance and engaging FcRn-mediated recycling. Pharmacologically it is a conventional GLP-1 receptor agonist: glucose-dependent insulin secretion, glucagon suppression, delayed gastric emptying and reduced appetite.
Is Efpeglenatide FDA approved?
No. Efpeglenatide is in Phase 3 clinical trials and not approved. Evidence level: human trials. Published clinical trials in people report results.
What is the half-life of Efpeglenatide?
Reported half-life: Consistent with weekly dosing; extended by Fc fusion.
How is Efpeglenatide taken?
Weekly subcutaneous injection (investigational).
What side effects have been reported with Efpeglenatide?
Reported in the sources: Gastrointestinal effects characteristic of the GLP-1 class — nausea, vomiting, diarrhea; Exendin-based GLP-1 agonists carry a higher rate of anti-drug antibody formation than human GLP-1-based agents such as semaglutide; Increased heart rate, as with the class; It is not approved by any major regulator and development has not resulted in a marketed product; long-term safety outside trials is not characterised.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.