What the FDA approved — exact wording
The approval covers semaglutide for adults with biopsy-confirmed MASH and significant liver fibrosis (F2 or F3). It does not cover patients with cirrhosis (F4) or no fibrosis (F0).
In practice, this means semaglutide is now an FDA-approved option for a specific group of MASH patients — those with active inflammation and moderate to significant scarring, but without cirrhosis.
The ESSENCE trial data
ESSENCE was the Phase 3 trial that supported approval. Key findings at 72 weeks:
- 62.9% of patients on semaglutide achieved histological MASH resolution (vs 17% on placebo)
- 36.8% achieved one-stage fibrosis improvement (vs 22.5% on placebo)
- Elastography liver stiffness reductions averaged 4–7 kPa in responders
- Weight loss was similar to weight-management trials of semaglutide
- Safety profile consistent with established semaglutide use — GI tolerability the main issue
Critically, the histological improvements were greater than weight loss alone could explain. This supports direct hepatic action of semaglutide via GLP-1 receptors expressed in liver tissue.
What this means for Australian patients
The TGA has not yet approved semaglutide specifically for the MASH indication. However:
- Ozempic is TGA-approved for type 2 diabetes
- Wegovy is TGA-approved for weight management
- Most patients with MASH have one or both of those indications, so semaglutide is already accessible
- A TGA application for the MASH indication is anticipated. Until then, MASH treatment is effectively off-label or via the weight-management or T2D pathway
The AASLD updated its MASH guidance in November 2025 to include semaglutide. The 2026 EASO guideline positions both semaglutide and tirzepatide in the treatment algorithm.
How elastography fits in
The FDA approval is for biopsy-confirmed MASH with F2–F3 fibrosis. In Australian practice, biopsy is rarely used as the primary diagnostic — elastography is the standard. A kPa above 8 typically suggests F2+ fibrosis in MASLD; kPa above 12 suggests F3 or higher.
For a patient with metabolic risk factors and an indeterminate FIB-4, the pathway is:
- FIB-4 score from routine bloods
- Elastography if FIB-4 is indeterminate
- If kPa > 8 and patient meets other criteria → consider semaglutide for MASH
- Repeat elastography at 12 months to track response (≥5 kPa reduction = meaningful)
Frequently asked questions
Is semaglutide approved for MASH in Australia?
TGA approval for the MASH-specific indication is anticipated but not yet confirmed. Semaglutide is already TGA-approved for type 2 diabetes (Ozempic) and weight management (Wegovy), so patients with MASH and either of those conditions can usually access it through standard channels.
Does the MASH approval cover cirrhosis?
No. The FDA approval is for biopsy-confirmed MASH with F2 or F3 fibrosis — not F4 (cirrhosis) or F0 (no fibrosis). Patients with cirrhosis need specialist hepatology management.
What was the ESSENCE trial outcome?
At 72 weeks, 62.9% of semaglutide-treated patients achieved histological MASH resolution vs 17% on placebo, with 36.8% showing fibrosis improvement vs 22.5% on placebo. Elastography liver stiffness reductions averaged 4–7 kPa in responders.
Will Wegovy be PBS-listed for MASH in Australia?
Wegovy is awaiting PBS listing for weight management. PBS listing for a MASH-specific indication would require both TGA approval and a separate PBS submission — neither is yet finalised.
Need elastography before considering semaglutide for MASH?
Get a baseline liver stiffness measurement so you and your GP can stage fibrosis accurately and track response over the first 12 months of treatment.
This page is educational and not medical advice. Always discuss your GLP-1 treatment and liver monitoring with your GP.