Efinopegdutide (MK-6024; formerly HM12525A / JNJ-64565111; Merck, licensed from Hanmi) is a GLP-1/glucagon co-agonist developed primarily for MASLD/MASH. In a phase 2a...
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Efinopegdutide
MARKETEDGLP-1/glucagon (GCGR) dual agonist
5
graded findings
4
effect domains
Evidence spread
High evidence 0Moderate evidence 5Low evidence 0Very low evidence 0
Efinopegdutide is shown as a marketed evidence record where applicable. Findings describe observed research and regulatory records; they do not provide treatment advice.
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
Efinopegdutide
MARKETED
Romero-Gomez et al., phase IIa efinopegdutide in NAFLD, J Hepatol 2023 (EASL 2023)
Source
Full findingEfinopegdutide (MK-6024; formerly HM12525A / JNJ-64565111; Merck, licensed from Hanmi) is a GLP-1/glucagon co-agonist developed primarily for MASLD/MASH. In a phase 2a active-comparator open-label study in NAFLD, efinopegdutide 10 mg weekly produced a significantly greater relative liver-fat reduction at 24 weeks than semaglutide 1 mg weekly; weight loss was 8.5% (efinopegdutide) vs 7.1% (semaglutide), with higher GI adverse-event incidence.
PopulationAdults with NAFLD; phase 2a randomised active-comparator open-label, efinopegdutide 10 mg vs semaglutide 1 mg weekly, 24 wk (NCT04944992)
Fundingindustry - Merck Sharp & Dohme LLC (efinopegdutide licensed from Hanmi)
Scope limitsno outcome data yet (ongoing); open-label (unblinded)
Comparatorssemaglutide
Efinopegdutide
MARKETED
In a phase 2a open-label active-comparator NAFLD trial (LFC >=10%), the GLP-1/glucagon dual efinopegdutide produced a significantly greater relative MRI-PDFF liver-fat...
Romero-Gómez M et al. A phase IIa active-comparator-controlled study to evaluate the effi...
Source
Full findingIn a phase 2a open-label active-comparator NAFLD trial (LFC >=10%), the GLP-1/glucagon dual efinopegdutide produced a significantly greater relative MRI-PDFF liver-fat reduction at 24 weeks than the GLP-1-mono semaglutide, at numerically (non-significantly) greater weight loss.
PopulationNCT04944992; N=145 (efinopegdutide 72 / semaglutide 73); NAFLD LFC >=10%, 33% T2D; open-label; 24 wk.
Fundingindustry-Merck (Merck Sharp & Dohme LLC; efinopegdutide licensed from Hanmi)
Scope limitsopen-label (unblinded)
Comparatorssemaglutide
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
Efinopegdutide
MARKETED
GLP-1/glucagon receptor co-agonist; glucagon arm posited to drive direct hepatic fatty-acid oxidation/reduced lipogenesis
Romero-Gómez M et al. A phase IIa active-comparator-controlled study to evaluate the effi...
Source
PopulationMechanistic framing in NAFLD trial
Fundingindustry-Merck (Merck Sharp & Dohme LLC; efinopegdutide licensed from Hanmi)
Scope limitsopen-label (unblinded)
Comparatorssemaglutide
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
Efinopegdutide
MARKETED
Slightly higher AEs vs semaglutide, mainly GI
Romero-Gómez M et al. A phase IIa active-comparator-controlled study to evaluate the effi...
Source
PopulationNAFLD (n=145), phase 2a, 24 wk
Fundingindustry-Merck (Merck Sharp & Dohme LLC; efinopegdutide licensed from Hanmi)
Scope limitsopen-label (unblinded)
Comparatorssemaglutide 1 mg
Thin or bounded evidence here means uncertainty remains visible. It is not evidence that an effect has been ruled out.
Efinopegdutide
MARKETED
Weight loss numerically greater than semaglutide but not statistically significant
Romero-Gómez M et al. A phase IIa active-comparator-controlled study to evaluate the effi...
Source
PopulationNAFLD (n=145), phase 2a, 24 wk, open-label
Fundingindustry-Merck (Merck Sharp & Dohme LLC; efinopegdutide licensed from Hanmi)
Scope limitsopen-label (unblinded)
Comparatorssemaglutide 1 mg