Peptide LibraryEfpeglenatide dosage in published studies and labels
These are the doses used for Efpeglenatide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Efpeglenatide has no approved dosage. Human dosing comes from the AMPLITUDE phase 3 programme in type 2 diabetes, which tested 2, 4 or 6 mg injected under the skin once a week; in the AMPLITUDE-O outcomes trial, 4 or 6 mg weekly lowered the risk of major cardiovascular events against placebo. Four phase 3 trials are listed on ClinicalTrials.gov as terminated by sponsor decision, not for safety reasons, and the drug was not approved.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 2–6 mg once weekly in phase 3 trials |
| Route | Subcutaneous |
| Frequency | Once weekly (once-monthly dosing was tested in phase 2) |
| Duration studied | Up to 56 weeks of treatment; median follow-up 1.81 years in AMPLITUDE-O |
| Titration | In the AMPLITUDE trial against dulaglutide, participants started at 2 mg weekly and stepped up every 2 weeks to 4 mg or 6 mg. |
| Half-life | 135–180 hours (geometric mean) in phase 2 studies in type 2 diabetes |
| Evidence level | Clinical Trial Evidence |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| AMPLITUDE-O — phase 3 cardiovascular and kidney outcomes (NCT03496298)Clinical trial · Randomized, placebo-controlled phase 3 outcomes trial | Adults with type 2 diabetes and cardiovascular disease or kidney disease plus a risk factor (n=4,076) | 4 mg or 6 mg | Subcutaneous | Once weekly | Median follow-up 1.81 years | Major cardiovascular events in 7.0% with efpeglenatide against 9.2% with placebo (hazard ratio 0.73); composite kidney outcome in 13.0% against 18.4% (hazard ratio 0.68) | Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes. N Engl J Med. 2021. |
| AMPLITUDE-M — phase 3 monotherapyClinical trial · Randomized, double-blind, placebo-controlled phase 3 trial | Adults with type 2 diabetes on diet and exercise alone (n not stated in the indexed abstract) | 2, 4 or 6 mg | Subcutaneous | Once weekly | Up to 56 weeks (primary endpoint at week 30) | HbA1c fell from 8.1% to 6.9%, 6.6% and 6.4% at week 30 with 2, 4 and 6 mg; each dose beat placebo | Efficacy and Safety of Once-Weekly Efpeglenatide Monotherapy Versus Placebo in Type 2 Diabetes: The AMPLITUDE-M Randomized Controlled Trial. Diabetes Care. 2022. |
| Phase 2 single-dose and repeated-dose studiesClinical trial · Two randomized, double-blind, placebo-controlled phase 2 trials | Adults with type 2 diabetes (n=48 single-dose; n=71 repeated-dose) | Single dose 2–100 mcg/kg; repeated 1, 2 or 4 mg weekly or 8, 12 or 16 mg monthly | Subcutaneous | Single dose, once weekly or once monthly | Single dose; 8 weeks (weekly) or 9 weeks (monthly) | Dose-proportional exposure; repeated doses lowered HbA1c against placebo; gastrointestinal effects most common | Pharmacokinetic and dose-finding studies on efpeglenatide in patients with type 2 diabetes. Diabetes Obes Metab. 2020. |
| AMPLITUDE trial versus dulaglutide — terminated (NCT03684642)Clinical trial · Phase 3 randomized trial, terminated | Adults with type 2 diabetes on metformin (n=908) | Started at 2 mg and raised every 2 weeks to 4 mg or 6 mg (compared with dulaglutide 1.5 mg) | Subcutaneous | Once weekly | Up to 56 weeks | Terminated; the registry reason is "Sponsor decision to cancel TRIAL, not related to safety concern". Results are posted on ClinicalTrials.gov and not summarised here | NCT03684642 — Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin |
Where sources disagree
- Efpeglenatide was not approved. Four phase 3 efpeglenatide records on ClinicalTrials.gov, including AMPLITUDE-O (NCT03496298), are listed as terminated by sponsor decision "not related to safety concern". AMPLITUDE-O still reported its primary outcome.
- Efpeglenatide is an exendin-based GLP-1 receptor agonist. Its milligram doses are not interchangeable with exenatide, which is dosed in micrograms, or with other weekly GLP-1 drugs.