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Evidence: LowPeptide conjugate Clinical Trials Pipeline & In-Development

Efocipegtrutide

also known as: HM15211, HM-15211, Efocipegtrutida

Hanmi's once-weekly GLP-1/GIP/glucagon triple agonist, a peptide joined to an antibody Fc fragment and aimed at fatty liver disease with fibrosis (MASH). Its 215-patient phase 2b trial finished in July 2026 with no results out yet; the human figures so far are the company's phase 1 reports.

Efocipegtrutide (HM15211) is a long-acting injectable from Hanmi Pharmaceutical that activates the GLP-1, GIP and glucagon receptors, the receptor set of Lilly's retatrutide, but built as a peptide joined by a flexible synthetic linker to a human antibody Fc fragment so that one injection lasts a week. In Hanmi's 12-week phase 1b/2a trial in 66 adults with obesity and fatty liver, liver fat fell by 81% on average at the highest weekly dose against 6% on placebo (company conference abstract; registry results posted). A 52-week phase 2b trial in 215 people with biopsy-proven MASH (NCT04505436; design paper PMID 37028504) was completed in July 2026 and has not reported. It is approved nowhere.

No dosing data yet Details ↓

Mechanism of action

One peptide switches on three hormone receptors. GLP-1 receptor activity curbs appetite and lifts glucose-dependent insulin release, GIP is the second gut incretin, and glucagon receptor activity raises energy use and fat burning in the liver; Hanmi describes the molecule as a full agonist at all three, joined to a human Fc fragment through a flexible synthetic linker so it stays in the blood for days (Hanmi pipeline page; ChEMBL CHEMBL5095149). In people, single doses had half-lives of about 72 to 142 hours and lowered the body's own incretin and glucagon levels in a dose-related way (Hanmi's ADA 2019 abstract). Hanmi's mouse work credits the glucagon component with the anti-inflammatory and anti-fibrotic effects in the liver, because a glucagon-only agonist matched it there and the GLP-1/GIP dual agonist tirzepatide did not (AASLD 2024 poster, animal data); the design paper calls the phase 1 and rodent results promising (PMID 37028504).

Primary uses

  • Investigational: MASH (NASH) with liver fibrosis stage F1 to F3 (phase 2b, completed, results not yet reported)
  • Investigational: fatty liver disease with obesity (phase 1b/2a, completed)

Typical dosing

weekly in trials (subcutaneous)

No approved dose and no dose in a peer-reviewed paper. The two phase 1 trials gave weight-based doses under the skin, once or weekly for 12 weeks, as their posted registry results record (see the trial cards below); the phase 2b trial's doses have not been published.

Educational information, not medical advice. The doses on this page come from approved labels, published studies and, where no study exists, amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.

Regulatory status

Not approved anywhere: Drugs@FDA and the openFDA label endpoint hold no record for efocipegtrutide or HM15211 (searched November 4, 2026), and ChEMBL records a highest clinical phase of 2 (CHEMBL5095149). Hanmi Pharmaceutical has registered three trials: a single ascending dose study in 41 adults with obesity (NCT03374241, completed 2018, results posted), a 12-week multiple dose study in 66 adults with obesity and fatty liver (NCT03744182, completed 2020, results posted) and the phase 2b HM-TRIA-201 trial in 215 adults with biopsy-confirmed NASH in the United States and South Korea (NCT04505436, completed July 2026, no results posted). Hanmi reports FDA fast track designation for MASH and FDA and EMA orphan drug designations for idiopathic pulmonary fibrosis, primary biliary cholangitis and primary sclerosing cholangitis (company release, December 3, 2024).

Status as of this entry's last review, November 4, 2026. Approvals, compounding rules and sport rules change; the regulatory tracker is checked more often.

What the studies show

One paper in PubMed is about this molecule, and it describes a trial design rather than results. The human figures below come from the two phase 1 trials' results posted on ClinicalTrials.gov and from Hanmi's own conference abstracts, which the company presented and which have not been peer reviewed as full papers. Reviews that only list it among triple agonists are in References.

Human · 2023

HM-TRIA-201: how the phase 2b trial in NASH was designed

Hanmi and its investigators set out a 52-week, placebo-controlled, double-blind trial of weekly injections in about 217 adults whose NASH was confirmed by liver biopsy. Success means a repeat biopsy showing the steatohepatitis has resolved with no worsening of fibrosis. To spare patients extra biopsies, the design is adaptive: once 15 patients per group had finished 26 weeks, one of the dose groups was to be closed on safety and efficacy grounds and its patients re-randomised to the other two. The paper reports no results.

PMID 37028504

Registry · 2018

First-in-human single doses, results posted

Forty-one otherwise healthy adults with obesity received one injection under the skin of 0.01, 0.02, 0.04, 0.08 or 0.12 mg/kg, or placebo. The posted results show no serious adverse event in any group, with stomach and gut complaints concentrated at the two top doses (4 of 7 and 4 of 6, against 1 of 10 on placebo). Hanmi's ADA 2019 abstract adds that blood levels rose in step with the dose, the half-life was about 72 to 142 hours, which it took as support for weekly dosing, and heart rate and blood pressure did not change meaningfully.

NCT03374241 · ClinicalTrials.gov record

Registry · 2018

Twelve weeks of weekly doses in obesity with fatty liver, results posted

Sixty-six adults with obesity, no diabetes and liver fat of at least 10% were randomised three to one to weekly 0.01 to 0.08 mg/kg or placebo for 12 weeks. No serious adverse event occurred; nausea was the commonest effect and rose with dose (3 of 9 at each of the two highest doses, 1 of 17 on placebo). In Hanmi's EASL 2020 abstract, liver fat measured by MRI fell by an average of 81% at 0.08 mg/kg against about 6% on placebo, and every patient at that dose lost at least 30% of their liver fat; placebo-adjusted weight loss reached about 5% at that dose. Two patients developed high blood sugar that settled after the drug was stopped.

NCT03744182 · ClinicalTrials.gov record

Registry · 2020

Phase 2b in biopsy-confirmed NASH, completed, not yet reported

Two hundred and fifteen adults with NASH and fibrosis stage F1 to F3 on biopsy, at 60 sites in the United States and South Korea, received the drug or placebo for 12 months. The registry marks it completed on July 15, 2026, with no results posted. Hanmi said in December 2024 that the trial's independent data monitoring committee had advised keeping every dose group going.

NCT04505436 · ClinicalTrials.gov record

References

  1. [pubmed] Abdelmalek MF, et al. "A phase 2, adaptive randomized, double-blind, placebo-controlled, multicenter, 52-week study of HM15211 in patients with biopsy-confirmed non-alcoholic steatohepatitis - Study design and rationale of HM-TRIA-201 study." Contemp Clin Trials, 2023;130:107176. PMID: 37028504.
  2. [pubmed] Bailey CJ, et al. "Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities." Peptides, 2025;187:171380. PMID: 40081498.
  3. [pubmed] Bhat S, et al. "Efficacy and safety of incretin co-agonists: Transformative advances in cardiometabolic healthcare." World J Cardiol, 2025;17(8):107991. PMID: 40949933.
  4. [pubmed] Jepsen MM, et al. "Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity." Expert Opin Emerg Drugs, 2021;26(3):231-243. PMID: 34176426.
  5. [clinicaltrials] ClinicalTrials.gov NCT03374241: "A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Dose of HM15211(Efocipegtrutide) in Healthy Obese Subjects" Hanmi Pharmaceutical Company Limited. Phase 1, randomised, triple-masked, 41 participants at one site in Chula Vista, California, April to September 2018, completed; single subcutaneous doses of 0.01, 0.02, 0.04, 0.08 or 0.12 mg/kg against placebo. Results posted May 17, 2024: no serious adverse event in any group; gastrointestinal events in 4 of 7 at 0.08 mg/kg, 4 of 6 at 0.12 mg/kg and 1 of 10 on placebo. Registry record read November 4, 2026.
  6. [clinicaltrials] ClinicalTrials.gov NCT03744182: "A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD" Hanmi Pharmaceutical Company Limited. 66 adults with obesity, no diabetes and liver fat of at least 10% by MRI-PDFF, randomised 3:1 to weekly subcutaneous doses of 0.01, 0.02, 0.04, 0.06 or 0.08 mg/kg or placebo for 12 weeks, November 2018 to March 2020, completed. Results posted January 27, 2025: no serious adverse event in any group; nausea in 3 of 9 at each of the two highest doses and 1 of 17 on placebo. Registry record read November 4, 2026.
  7. [clinicaltrials] ClinicalTrials.gov NCT04505436 (HM-TRIA-201): "A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) Treatment for 12 Months in Subjects With Biopsy Confirmed NASH" Hanmi Pharmaceutical Company Limited. 215 adults with non-cirrhotic NASH and fibrosis stage F1 to F3 on biopsy, 60 sites in the United States and South Korea, July 2020 to July 15, 2026 (primary completion June 26, 2026), completed; primary endpoint resolution of steatohepatitis without worsening of fibrosis at 12 months. No results posted. Registry record read November 4, 2026.
  8. [manufacturer] Choi JD, Baek S, Kim Y, Eun K, Kwon SC, Morrow L, Hompesch M, Kang J. "A Double-Blinded, Placebo Controlled, Single Ascending Dose Study for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Subcutaneous Administration of Novel Long-Acting GLP-1/GIP/Glucagon Triple Agonist (HM15211) in Healthy Obese Subjects." Diabetes, 2019;68(Supplement 1):982-P. doi:10.2337/db19-982-P. Conference abstract by Hanmi Pharmaceutical and ProSciento; Hanmi's poster read November 4, 2026.
  9. [manufacturer] Abdelmalek M, Choi J, Kim Y, Seo K, Hompesch M, Baek S. "HM15211, a novel GLP-1/GIP/Glucagon triple-receptor co-agonist significantly reduces liver fat and body weight in obese subjects with non-alcoholic fatty liver disease: A Phase 1b/2a, multi-center, randomized, placebo-controlled trial." J Hepatol, 2020;73(Supplement 1):S124. doi:10.1016/S0168-8278(20)30765-0. Conference abstract by Hanmi Pharmaceutical and its investigators; Hanmi's poster read November 4, 2026.
  10. [manufacturer] Hanmi Pharmaceutical. Press release, December 3, 2024: "'Efocipegtrutide' by Hanmi Pharmaceutical Shows Promising Efficacy in Liver Fibrosis Improvement" (mouse data presented at AASLD 2024; the phase 2b trial's independent data monitoring committee recommended that every dose group continue; FDA fast track designation for MASH; FDA and EMA orphan drug designations for idiopathic pulmonary fibrosis, primary biliary cholangitis and primary sclerosing cholangitis; company statements). https://hanmipharm.com/about/investor-relations/press/detail-1502.hm. Read November 4, 2026.
  11. [manufacturer] Hanmi Pharmaceutical. Efocipegtrutide (HM15211) pipeline page: a long-acting glucagon/GIP/GLP-1 triple agonist chemically joined to a human immunoglobulin Fc region through a non-peptidyl flexible linker; phase 2b in biopsy-confirmed MASH with fibrosis in the US and Korea (company statements). https://www.hanmipharm.com/science/pipeline/focused/efocipegtrutide.hm. Read November 4, 2026.
  12. [manufacturer] Hanmi Pharmaceutical. "Glucagon engagement is essential for the direct anti-inflammation and anti-fibrosis effect of efocipegtrutide in TAA-induced mouse model of liver injury and fibrosis." AASLD The Liver Meeting 2024 poster. https://www.hanmipharm.com/science-pdf/HM15211/2024_AASLD_Poster_efocipegtrutide.pdf. Read November 4, 2026.
  13. [manufacturer] Hanmi Pharmaceutical. "Anti-fibrotic and mortality reduction potential of a novel long-acting glucagon/GIP/GLP-1 triple agonist in preclinical models of idiopathic pulmonary fibrosis." ATS International Conference 2023 poster P1055. https://www.hanmipharm.com/science-pdf/HM15211/2023_ATS_Poster_efocipegtrutide.pdf. Read November 4, 2026.
  14. [other] ChEMBL molecule CHEMBL5095149 (EFOCIPEGTRUTIDE), read November 4, 2026: molecule type Protein; INN stems ef-, -peg- and -tide; highest clinical phase recorded 2; components a 40-residue conjugated peptide (YXQGTFTSDYSKYLDEKRAKEFVQWLLDHHPSSGQPPPSC, X a non-standard residue) and a 221-residue immunoglobulin Fc monomer with its disulfide bridges. https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5095149/
  15. [other] US FDA, Drugs@FDA and the drug label endpoint (openFDA), searched November 4, 2026: no application and no label record for efocipegtrutide or HM15211.

Related peptides

Retatrutide

An investigational triple hormone agonist that produced 24.2% weight loss at 48 weeks in phase 2 and 28.7% at 68 weeks in the TRIUMPH-4 phase 3 trial.

HM15275

Hanmi's weekly GLP-1/GIP/glucagon triple agonist, a fatty-acid-linked peptide in the same class as retatrutide; phase 2 in obesity and type 2 diabetes, with only company-reported phase 1 data.

Efinopegdutide

A GLP-1 and glucagon dual agonist that failed to stand out for weight loss, then found a second life in fatty liver disease, where it cut liver fat by almost three-quarters.

HM15136

A weekly glucagon analogue in early trials for congenital hyperinsulinism, where raising blood sugar is the point.

Survodutide

A once-weekly glucagon/GLP-1 dual agonist: about 13% weight loss at 76 weeks in phase 3 and MASH improvement in phase 2, but not yet approved anywhere.

Pemvidutide

Altimmune's GLP-1 / glucagon co-agonist — received FDA Breakthrough Therapy Designation for MASH in January 2026 after positive IMPACT Phase 2b antifibrotic data, with Phase 3 initiation planned for 2026.

Guides & tools

Disclaimer

This entry is for educational purposes only and does not constitute medical advice. Dosing information reflects published regulatory or research data and is not a recommendation. Many compounds described here are not approved for human use in the United States. Consult a licensed medical professional before considering any peptide therapy.