Lipids & metabolic liver disease
Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial
An erratum to this article was published (Nat Med, Oct 2026 ↗)
Authors' conclusion
In adults with obesity and at-risk MASLD, survodutide treatment was statistically and clinically superior to placebo for reductions in MRI-PDFF-assessed LFC and body weight.
Study context
- Population
- Adults with obesity (BMI ≥30 kg m-2 or ≥27 kg m-2 with ≥1 obesity complication) and at-risk MASLD (liver inflammation and/or fibrosis by noninvasive tests or biopsy-confirmed MASH); 131 female, 85 malerandomized 2:1
- Participants
- 216 adults
- Comparison
- Once-weekly subcutaneous survodutide 6.0 mg vs placebo
- Survodutiden = 146
- Placebon = 70reference
- Primary endpoint
- Co-primary: ≥30% reduction in magnetic resonance imaging-proton density fat fraction (MRI-PDFF)-assessed liver fat content and percentage change in body weight
- Follow-up
- Baseline to week 48
Methodological detailsdouble-blind, placebo-controlled, phase 3, Participants recruited in the United States and Spain
- Double-blind
- Placebo-controlled
- Phase 3
- Participants recruited in the United States and Spain
Primary result
As reported in the abstract
≥30% reduction in MRI-PDFF-assessed LFC; mean % change in body weight · week 48
≥30% reduction in MRI-PDFF-assessed LFC; mean % change in body weight · week 48
≥30% LFC reduction, treatment regimen estimand
P < 0.0001
Mean % change in body weight, efficacy estimand Survodutide −12.2% · Placebo −1.0%
Mean % change in body weight, treatment regimen estimand Survodutide −8.7% · Placebo −1.4%
- Survodutide vs Placebo: P < 0.0001 — ≥30% liver fat content (LFC) reduction, efficacy estimand
- Survodutide vs Placebo: P < 0.0001 — body weight % change, efficacy estimand
- Survodutide vs Placebo: P < 0.0001 — body weight % change, treatment regimen estimand
Safety
Adverse events
- Most frequent AEs with survodutide were gastrointestinal, commonly during dose escalation, generally mild-to-moderate
Original publication
Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial. Nat Med. Published 7 June 2026. doi:10.
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