Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library · Trial & Regulatory Tracker →

Efpeglenatide (HM11260C, Eppe): what the evidence says

Name: Efpeglenatide (HM11260C, Eppe)
Published: 2026-10-27

At a glance

What it is: a weekly exendin-4-based GLP-1 receptor agonist attached to an antibody (Fc) fragment, from Hanmi; Sanofi licensed it and returned it. ^R1 South Korea approved it for weight management in adults without diabetes on Oct 7, 2026, as "Eppe". ^R1 Not FDA-approved.

What the evidence says: in AMPLITUDE-O (4,076 people with type 2 diabetes and heart or kidney disease), major heart events dropped (HR 0.73) and kidney outcomes improved (HR 0.68). ^R2 A Korean phase 3 in 448 adults with obesity reported 9.75% average weight loss vs 0.95% on placebo at 40 weeks. ^R3

Biggest risks: diarrhea, constipation, nausea, vomiting and bloating. ^R2

Rating


Human Human evidence	Moderate: AMPLITUDE-O, n = 4,076 ^R2; Korean obesity phase 3, n = 448, company-reported ^R3
Animal Animal / lab evidence	Not reviewed
Regulatory	Not FDA-approved · approved in South Korea, Oct 2026 ^R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R4, R5, R6} · not named by WADA ^R7
Established human dose	Korea label only; none in the US

Evidence verdict: Heart and kidney outcomes in type 2 diabetes: Moderate (one large RCT, stopped early for business reasons) · Weight loss without diabetes: Moderate (one Korean phase 3, approved in Korea) · US status: Not FDA-approved

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: AMPLITUDE-O is a large randomized trial but was cut short. UNVERIFIED the stop reason, believed to be Sanofi dropping the program. The obesity result is company-reported and not yet peer reviewed.

What is it?

Related pages: Exenatide, Dulaglutide, Semaglutide.

Does it work?

Human Heart and kidney (AMPLITUDE-O): MACE 7.0% vs 9.2% (HR 0.73); kidney composite 13.0% vs 18.4% (HR 0.68). ^{R2, R8} UNVERIFIED the 7.0% vs 9.2% event rates, which are from the full text.
Human Weight (Korean phase 3): −9.75% vs −0.95% at 40 weeks; 79% lost at least 5%. ^R3

Is it safe?

Human Stomach side effects were more common than with placebo. ^R2 In the Korean trial nausea was 16.7%, vomiting 11.7% and diarrhea 17.7%. ^R3

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: investigational; Sanofi's phase 3 program was terminated. ^R8
South Korea: approved for weight management in adults without diabetes. ^R1
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R4, R5, R6}
Sport: not named on WADA's 2026 Prohibited List. ^R7

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
AMPLITUDE-O 2021	4,076 adults, T2D + CVD/CKD	SC weekly	4 or 6 mg weekly	Median 1.8 years	MACE HR 0.73	PMID 34215025
Korean obesity phase 3 (company)	448 adults, no diabetes	SC weekly	Strengths 2 to 10 mg (company filing)	40 weeks	−9.75% weight (company-reported)	Hanmi KRX filing, Dec 17, 2025

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Hanmi Pharmaceutical press release, 'Eppe' MFDS marketing approval, Oct 7, 2026 (Korean). https://www.hanmi.co.kr/about/news-media/press/detail-5083.hm
^R2 Gerstein HC, et al. N Engl J Med. 2021. PMID 34215025
^R3 Hanmi Pharmaceutical, KRX disclosure of MFDS application with phase 3 topline results, Dec 17, 2025 (Korean). https://kind.krx.co.kr/external/2025/12/17/000622/20251216000193/92008.htm
^R4 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R5 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R6 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R8 ClinicalTrials.gov NCT03496298, AMPLITUDE-O, Sanofi, terminated (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03496298

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Efpeglenatide (HM11260C, Eppe). This is an investigational drug. Outside a registered clinical trial, any product sold under this name is unregulated. In South Korea it is a prescription medicine. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).