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Wegovy for fatty liver disease (MASH): what does Australia's provisional approval mean?

What MASH is, the 2026 approval and why it is provisional, what the ESSENCE trial found, side effects, and the PBS.

GLP Guidebook teamPublished 12 Oct 20266 min read12 sourcesWritten from published sources

Written for Australia. Other country versions are coming.

The short answer

Wegovy (semaglutide) has provisional TGA approval to treat MASH, a fatty liver disease with inflammation, in adults with moderate to advanced liver scarring but no cirrhosis. It rests on 72-week biopsy results; longer trials must confirm the benefit. It is not PBS-subsidised. Stomach side effects were common.

Key takeaways

  • The Australian Wegovy PI lists non-cirrhotic MASH with moderate to advanced liver fibrosis (stages F2 to F3) as an approved use, via the provisional approval pathway.1
  • In the ESSENCE trial, liver inflammation cleared without worse scarring in 62.9% on semaglutide and 34.3% on a dummy injection after 72 weeks.1,2
  • Liver scarring improved by at least one stage in 36.8% on semaglutide against 22.4% on a dummy injection; Novo Nordisk paid for the trial.1,2
  • Provisional registration lasts 2 years and can be extended to a maximum of 6 years while confirmatory trial data are collected, the TGA says.5
  • In the MASH trial, 36.1% on Wegovy felt sick against 12.4% on a dummy injection, the Australian PI says.1
On this page
  1. What has Wegovy been approved for in fatty liver disease?
  2. What is MASH, and how common is fatty liver in Australia?
  3. What does a provisional approval mean?
  4. What did the ESSENCE trial find?
  5. Is Wegovy on the PBS for fatty liver?
  6. What are the side effects of Wegovy in MASH?
  7. Questions people ask
  8. How we researched this

What has Wegovy been approved for in fatty liver disease?

For adults with MASH and moderate to advanced liver scarring (fibrosis stages F2 to F3), who do not have cirrhosis. newsGP reported the provisional approval on 1 April 2026.1,3

Before you go further
  • Wegovy is a prescription-only medicine in Australia. A prescriber decides whether it suits you.
  • Label facts come from the Australian Product Information (PI), revised 22 June 2026.1
  • We don't publish medicine prices for Australia. The TGA treats price information for prescription medicines as advertising unless strict rules are met.8
  • Every risk of semaglutide is in Guide 5: Side effects and risks.
  • This post describes a label and a trial. It is not a plan for your treatment, and no medicine guarantees any result.

The TGA's Advisory Committee on Medicines looked at the application in February 2026, listed as a provisional application.6 The PI now says the use "was approved via the provisional approval pathway based on resolution of steatohepatitis and improvement in liver fibrosis".1

  • Dose: the same steps as for weight, up to 2.4 mg a week. The 7.2 mg dose does not apply to MASH.1
  • Who can prescribe: newsGP reported that GPs will be able to prescribe it for this use.3
  • Not for cirrhosis: the indication excludes people whose scarring has reached cirrhosis (stage F4).1

What is MASH, and how common is fatty liver in Australia?

MASH stands for metabolic dysfunction-associated steatohepatitis: fat in the liver with inflammation and cell damage. The Liver Foundation says fatty liver disease affects about 1 in 3 Australians.4

  • Fatty liver on its own means extra fat stored in the liver.4
  • MASH adds inflammation. The Liver Foundation says about 1 in 5 people with fatty liver disease develop it.4
  • Fibrosis is scarring. The trial graded it from 0 (none) to 4 (cirrhosis).1 The approval covers stages 2 and 3.1

newsGP cited research projecting a 40% rise in MASH cases by 2030.3 An expert quoted there said MASH "is too often diagnosed after significant liver damage has occurred".3

The Liver Foundation says fatty liver disease is "largely preventable and, in many cases, reversible", and that losing 5 to 10% of body weight can help reduce liver damage.4 For a 90 kg person, that is 4.5 to 9 kg.

What does a provisional approval mean?

It is an early approval based on preliminary results, for serious conditions. The company must then supply confirmatory data, or the approval lapses after at most 6 years.5

  • The rule: provisional registration is for prescription medicines that treat serious and life-threatening conditions, based on "preliminary clinical data".5
  • The clock: it lasts 2 years, with up to 2 extensions, to a maximum of 6 years.5
  • The condition: the Wegovy PI says continued approval for MASH "depends on verification and description of clinical benefit in confirmatory trials".1

What is still unknown. The approval rests on liver biopsies at 72 weeks, which show inflammation and scarring.1 The PI reports no results yet on cirrhosis, liver failure, liver cancer or death. ESSENCE is an ongoing 240-week trial; the approval rests on its interim results.1,2

What did the ESSENCE trial find?

After 72 weeks, liver inflammation cleared in about 63 in 100 people on semaglutide, against 34 in 100 on a dummy injection. Scarring improved in 37 against 22.1,2

ESSENCE included 800 adults with MASH and stage 2 or 3 scarring, confirmed by liver biopsy. Average age was 56, 56% had type 2 diabetes and 27% were Asian.1 Novo Nordisk paid for it.2

ESSENCE results at 72 weeks
% of people, semaglutide 2.4 mg vs dummy injection, judged by liver biopsy
Australian Wegovy PI, Table 12, interim analysis of ESSENCE (534 on semaglutide, 266 on dummy), checked 12 Oct 2026.1

Read the dummy group too. More than a third on the dummy injection also had their inflammation clear.1 The medicine's added effect is the gap: about 29 percentage points for inflammation and 14 for scarring.2

People on semaglutide lost 10.5% of their weight, against 2.0% on the dummy.2 The trial did not show a clear difference in bodily pain scores.1,2

Free toolQuestions for your GP or liver specialist

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Open the question list

Is Wegovy on the PBS for fatty liver?

No. newsGP reported that Wegovy is not PBS-listed for MASH, and as of October 2026 Wegovy is not PBS-subsidised for any use.3,7

A GP quoted by newsGP said doctors should "consider affordability until the PBS catches up".3 We don't publish prices.8 See Wegovy and the PBS and private health insurance for what that means for cost.

What are the side effects of Wegovy in MASH?

Similar to the weight trials: mostly stomach effects. In ESSENCE, 36.1% felt sick against 12.4% on the dummy injection.1

Side effectWegovyDummy
Feeling sick (nausea)36.1%12.4%
Diarrhoea26.8%12.2%
Constipation22.1%7.8%
Vomiting18.5%5.6%

Australian Wegovy PI, Table 3, MASH trial (800 on Wegovy, 395 on dummy).1

  • Low blood sugar. Severe low blood sugar happened in 2.2% on Wegovy against 0.5% on the dummy in ESSENCE, where 56% had type 2 diabetes.1
  • Little data in some groups. The PI says safety data are limited for people with MASH and a BMI under 25, or under 23 for Asian people.1
  • Severe liver impairment. Experience is limited, and the PI advises caution.1
RisksThe risks, in brief
  • Pancreatitis has been reported with semaglutide, including fatal cases. The PI says to stop if it is suspected.1
  • Gallstones were reported in 1.4% on Wegovy against 0.8% on the dummy in the MASH trial.1
  • Dehydration from vomiting or diarrhoea can harm the kidneys.1
  • Sudden loss of sight (NAION) has been linked to semaglutide. Seek urgent care for any sudden vision loss.9
Full detail in Guide 5: Side effects and risks →
Get help now: call triple zero (000) if an illness is critical or life-threatening.10 For advice when you are not sure what to do, call the healthdirect nurse helpline free on 1800 022 222, 24 hours a day.10 If you think you have taken too much of a medicine, call the Poisons Information Centre on 13 11 26 at any time.11 Severe stomach pain that won't go away can be pancreatitis.1 You can report a side effect to the TGA online or through your GP or pharmacist.12

Questions people ask

Is Wegovy approved for fatty liver in Australia?

Yes, provisionally, for MASH with moderate to advanced scarring (stages F2 to F3) and no cirrhosis, in adults.1

What does provisional approval mean?

An early approval for a serious condition based on preliminary data. It lasts up to 6 years while confirmatory results are collected.5

Does Wegovy reverse liver scarring?

In ESSENCE, scarring improved by at least one stage in 36.8% on semaglutide and 22.4% on a dummy injection after 72 weeks.1

Is Wegovy on the PBS for MASH?

No. Wegovy is not PBS-subsidised for any use as of October 2026.3,7

Can people with cirrhosis use Wegovy for MASH?

The approved use excludes cirrhosis. The PI notes a small trial in compensated cirrhosis found no safety signals, with limited data.1

How we researched this

On 12 Oct 2026 we read the Australian Wegovy PI, the ESSENCE trial abstract, newsGP's April 2026 report, the Liver Foundation's April 2026 article, the TGA's page on provisional registration and the February 2026 ACM meeting statement.

Trial figures come from the Australian PI's interim ESSENCE tables. ESSENCE was paid for by Novo Nordisk. We found no date in the PI change table for when the MASH use was added, so we date it by the newsGP report. We don't publish Australian medicine prices.

Before you move on

  • Wegovy has provisional approval for MASH with F2 to F3 scarring, not cirrhosis.
  • In ESSENCE, inflammation cleared in 62.9% vs 34.3% at 72 weeks.
  • Long-term liver outcomes are still being studied.
  • It is not PBS-subsidised.
Side effects and risksYour optionsDoctor questions tool

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About GLP Guidebook

The monthly Australia update

An independent guide to GLP‑1 medicines. We don't sell medicines, take drug-company money or earn clinic commissions. Once a month: PBS decisions, TGA approvals, safety notices and recalls. How we write

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Sources

  1. Novo Nordisk. Wegovy (semaglutide) Australian Product Information, revised 22 June 2026. medsinfo.com.au Sections 4.1, 4.2, 4.4, 4.8 (Table 3, MASH columns) and 5.1 (ESSENCE, Tables 12 and 13).
  2. Sanyal AJ, Newsome PN, Kliers I et al. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis (ESSENCE). N Engl J Med 2025;392:2089–99. Funded by Novo Nordisk. DOI · PMID 40305708
  3. newsGP (RACGP). Wegovy approved to treat severe fatty liver disease (TGA provisional approval for non-cirrhotic MASH with F2–F3 fibrosis; GPs can prescribe; not PBS-listed). 1 April 2026. racgp.org.au
  4. Liver Foundation (Australia). New option offers hope for people with severe fatty liver disease (fatty liver affects about 1 in 3 Australians; "losing just 5–10% of body weight can help reduce liver damage"). 15 April 2026. liver.org.au
  5. Therapeutic Goods Administration. Apply for a prescription medicine via the provisional registration pathway (limited to 2 years, up to 2 extensions, maximum 6 years). Updated 1 May 2025. tga.gov.au
  6. Therapeutic Goods Administration. ACM meeting statement, Meeting 55, 5 February 2026 (semaglutide (WEGOVY), non-cirrhotic MASH, "Provisional"). Published 5 March 2026. tga.gov.au
  7. Pharmaceutical Benefits Scheme. Medicine status: semaglutide (Wegovy), established cardiovascular disease with obesity ("Medicine listed on the PBS: Has not yet occurred"). Information current as at 1 October 2026; page updated 23 July 2026. pbs.gov.au
  8. Therapeutic Goods Administration. Applying the Advertising Code rules: price information. Updated 21 July 2026. tga.gov.au
  9. Therapeutic Goods Administration. GLP-1 RAs and rare vision disorder (NAION). Medicine Safety Update, 23 July 2026. tga.gov.au
  10. Healthdirect Australia. How healthdirect can help you ("call triple zero (000) for an ambulance immediately"; nurse helpline 1800 022 222, 24 hours a day). healthdirect.gov.au
  11. Healthdirect Australia. Poisoning (Poisons Information Centre, 13 11 26, any time). healthdirect.gov.au
  12. Therapeutic Goods Administration. Reporting adverse events for consumers (online, or through your GP, nurse practitioner, midwife or pharmacist). Updated 2 September 2026. tga.gov.au

Last checked 12 Oct 2026 · Next review due 12 Apr 2027 · Report an error

How this post was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor, nurse or pharmacist before starting, stopping or changing any medicine. How we write