Page data last changed: . Registry refreshes and identity assessments are separate from scientific content review.
A long-acting exendin peptide extended by Fc conjugation — studied in large cardiovascular-outcome trials.
Also known as: SAR439977 · LAPS-Exendin
Part of the Metabolic & GLP-1 peptides cluster
Overview
Efpeglenatide is a long-acting GLP-1 receptor agonist built from an exendin-based peptide conjugated to an antibody Fc fragment for extended duration. It has been evaluated in large clinical programs, including the AMPLITUDE-O cardiovascular-outcomes trial, and remains investigational — it is not authorized by Health Canada.
Source & context
Biological / chemical source: Engineered exendin-4 analog conjugated to an antibody Fc fragment (LAPSCOVERY platform)
Primary research or clinical context: Investigational; not authorized by Health Canada
Half-life by Fc conjugation
Efpeglenatide pairs an exendin-4-derived peptide with an immunoglobulin Fc fragment via a flexible linker (the developer's LAPSCOVERY platform). Attaching the Fc slows clearance and supports infrequent dosing — a third distinct half-life-extension strategy alongside fatty-acid acylation and albumin fusion seen in other GLP-1 agonists.
Development and status
Efpeglenatide has been studied in a broad clinical program, most notably the AMPLITUDE-O trial evaluating cardiovascular outcomes in type 2 diabetes. Approval status varies by jurisdiction and over time; it is investigational and not authorized by Health Canada. This page is educational and is not treatment advice.
Structure & chemistry
Molecular identity & reference confidence
Reference mass unavailable
Reference values are taken from the cited molecular record or curated profile. A database match is not independent laboratory verification; modifications, counter-ions, and formulations can change the measured mass.
- Molecular form
- Efpeglenatide (source record; form not independently established)
- Species
- Not established by this molecular identity audit
- Termini (N / C)
- Not specified / Not specified
Average reference mass
Reference policy updated: 2026-10-05
Clinical development snapshot
ClinicalTrials.gov lists 5 registered studies with “Efpeglenatide” as an intervention (snapshot 2026-10-01). A registry footprint is not evidence of efficacy or approval.
| NCT | Title | Phase | Status | Updated |
|---|---|---|---|---|
| NCT03353350 | Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Con | Phase 3 | completed | 2022-01-18 |
| NCT03770728 | Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Con | Phase 3 | terminated | 2021-12-02 |
| NCT03713684 | Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Con | Phase 3 | terminated | 2021-12-02 |
| NCT03684642 | Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately | Phase 3 | terminated | 2021-11-01 |
| NCT03496298 | Effect of Efpeglenatide on Cardiovascular Outcomes | Phase 3 | terminated | 2021-10-15 |
FAQ about Efpeglenatide
What is Efpeglenatide?+
Efpeglenatide is a long-acting GLP-1 receptor agonist built from an exendin-based peptide conjugated to an antibody Fc fragment for extended duration. It has been evaluated in large clinical programs, including the AMPLITUDE-O cardiovascular-outcomes trial, and remains investigational — it is not authorized by Health Canada.
What Canadian product status is recorded for Efpeglenatide?+
Canadian product status for Efpeglenatide has not been verified in this profile. No verified record here does not mean no authorization exists. Status depends on the product, formulation and use; consult Health Canada's product records.
What is the typical length of Efpeglenatide?+
Efpeglenatide is not a classic amino-acid chain peptide in the same sense; see the profile for classification details.
Related peptides
References & further reading
- 1.Gerstein et al. (2021). Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med
- 2.Yoon et al. (2020). Pharmacokinetic and dose-finding studies on efpeglenatide in patients with type 2 diabetes. Diabetes Obes Metab
- 3.Hompesch et al. (2021). Effects of efpeglenatide versus liraglutide on gastric emptying, glucose metabolism and beta-cell function in people with type 2 diabetes: an exploratory, randomized phase Ib study. BMJ Open Diabetes Res Care
- 4.Frias et al. (2022). Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care
- 5.Pratley et al. (2022). Efficacy and safety of efpeglenatide in key patient subgroups from the BALANCE randomized trial, stratified by pre-diabetes status, BMI, and age at baseline. BMJ Open Diabetes Res Care
- 6.Escobar et al. (2023). Safety and Efficacy of Efpeglenatide in Patients With Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials. Cureus
- 7.Gerstein et al. (2023). Exploring the Relationship Between Efpeglenatide Dose and Cardiovascular Outcomes in Type 2 Diabetes: Insights From the AMPLITUDE-O Trial. Circulation
- 8.Del Prato et al. (2020). Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study. Diabetes Obes Metab
- 9.ClinicalTrials.gov — AMPLITUDE-O: Effect of Efpeglenatide on Cardiovascular Outcomes (NCT03496298)
- 10.Wikipedia — Efpeglenatide