An investigational long-acting GLP-1 receptor agonist made by linking an exendin-4 analog to an antibody (IgG4) Fc fragment, developed by Hanmi Pharmaceutical. It has been studied in phase 1 to phase 3 human trials, including a large cardiovascular outcomes trial published in 2021.
Efpeglenatide activates the GLP-1 receptor, the target of the gut hormone GLP-1, which is normally broken down within minutes by the enzyme DPP-4 [1]. It is a modified exendin-4 peptide joined through a non-peptide linker to the Fc fragment of human IgG4, which slows clearance; pooled human data estimate an effective half-life of about 6 to 7 days [1]. Effects on gastric emptying and beta-cell function were measured directly in a phase 1b study [4].
| Study | Model | Reported result | Source |
|---|---|---|---|
| AMPLITUDE-O, phase 3 [2] | Human 4,076 adults at elevated cardiovascular risk, randomized, placebo-controlled, 344 sites in 28 countries, median follow-up 1.8 years | Primary endpoint: time to first major adverse cardiovascular event (composite). Published | Peer-reviewed NEJM 2021 |
| Phase 2 study (2019) [3] | Human Adults without elevated blood sugar, randomized, placebo-controlled | Endpoints: body weight change and safety. Published | Peer-reviewed Diabetes Obes Metab 2019 |
| Phase 1b gastric emptying study [4] | Human Adults, exploratory randomized comparison with liraglutide | Measured gastric emptying, glucose metabolism and beta-cell function. Published | Peer-reviewed BMJ Open Diabetes Res Care 2021 |
| Monthly-interval phase 2 study [5] | Human Adults, randomized, placebo-controlled, 16 weeks | Endpoints: glycemic measures and safety across monthly-interval regimens. Published | Peer-reviewed Diabetes Obes Metab 2020 |
| Population pharmacokinetic analysis [1] | Human Pooled data, 498 participants from one phase 1 and five phase 2 trials | Modeled effective half-life about 6-7 days; clearance compared with dulaglutide. Published | Peer-reviewed Front Pharmacol 2025 |
Human trials are listed for research context only; outcomes are reported in the linked publications. Animal and lab results do not establish effects in humans.
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