Lipids & metabolic liver disease

Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial

Nat MedPublished Randomised controlled trial

Study context

Population
Participants of a 48-week phase 2 obesity study with MASLD and ≥10% liver fat
Participants
98 participants
Comparison
Once-weekly subcutaneous retatrutide vs placebo
Primary endpoint
Mean relative change from baseline in liver fat
Follow-up
24 weeks
Methodological detailsdouble-blind, placebo-controlled, phase 2a, substudy
  • Double-blind
  • Placebo-controlled
  • Phase 2a
  • Substudy

Primary result

As reported in the abstract

1 mg

−42.9%

mean

4 mg

−57.0%

mean

8 mg

−81.4%

mean

12 mg

−82.4%

mean

Placebo

+0.3%

mean

1 mg vs Placebo: P < 0.001 versus placebo · 4 mg vs Placebo: P < 0.001 versus placebo · 8 mg vs Placebo: P < 0.001 versus placebo · 12 mg vs Placebo: P < 0.001 versus placebo

Further findings

OutcomeValues
Normal liver fat (<5%) achieved · 24 weeks1 mg 27% · 4 mg 52% · 8 mg 79% · 12 mg 86% · Placebo 0%

Correlates of liver fat reduction

Liver fat (LF) reductions significantly related to changes in body weight, abdominal fat and metabolic measures associated with improved insulin sensitivity and lipid metabolism

Original publication

Triple hormone receptor agonist retatrutide for metabolic dysfunction-associated steatotic liver disease: a randomized phase 2a trial. Nat Med. Published 10 June 2024. doi:10.1038/s41591-024-03018-2

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