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Human evidence record · Retatrutide

Retatrutide Phase 2a MASLD liver-fat substudy

At week 24, mean liver-fat changes were -42.9%, -57.0%, -81.4% and -82.4% versus +0.3% placebo; 79% and 86% at 8/12 mg reached <5% liver fat.

Quick read
Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with obesity/overweight and MASLD with >=10% liver fat

How many?

n=98

What happened?

At week 24, mean liver-fat changes were -42.9%, -57.0%, -81.4% and -82.4% versus +0.3% placebo; 79% and 86% at 8/12 mg reached <5% liver fat.

What stops us overclaiming?

Substudy sample is much smaller than the main obesity trial; liver-fat improvement is not yet an approved MASLD indication.

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Key result

At week 24, mean liver-fat changes were -42.9%, -57.0%, -81.4% and -82.4% versus +0.3% placebo; 79% and 86% at 8/12 mg reached <5% liver fat.

Study details

Study designRandomized double-blind placebo-controlled substudy
PhasePhase IIa
PopulationAdults with obesity/overweight and MASLD with >=10% liver fat
Sample size98
RouteSubcutaneous
Regimen / exposure1, 4, 8 or 12 mg once weekly
Duration48 weeks
ComparatorPlacebo
Primary endpoint / questionRelative change in liver fat
Safety resultSafety profile arose within the parent obesity trial; GI and heart-rate signals remain relevant.
Key limitationsSubstudy sample is much smaller than the main obesity trial; liver-fat improvement is not yet an approved MASLD indication.
Registry / identifierPMID 38858523 / NCT04881760