The Wegovy label (revised 06/2026) lists Wegovy injection for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) with moderate to advanced liver fibrosis (stages F2 to F3) in adults, under accelerated approval, meaning continued approval may depend on a confirmatory trial. At week 72 of the ESSENCE trial, steatohepatitis resolved without worsening fibrosis in 63% on semaglutide 2.4 mg versus 34% on placebo, and fibrosis improved without worsening steatohepatitis in 37% versus 22%. The trial runs 240 weeks, and the label does not claim outcomes such as cirrhosis or liver transplant.
A liver indication most patients have not heard about
Wegovy is widely known for weight management and, more recently, cardiovascular risk reduction. Its label also covers a liver disease. MASH is the more severe, inflammatory form of metabolic dysfunction-associated steatotic liver disease (MASLD), and the label’s wording “formerly known as nonalcoholic steatohepatitis (NASH)” explains why you may see either term. This article sets out what the label and the pivotal trial report, including the caveats attached to an accelerated approval.
We read the Wegovy label (revised 06/2026) on 14 October 2026, focusing on sections 1, 2.2, 5, 6.1 and 14.4 and the Medication Guide, along with the NEJM report of the ESSENCE trial as indexed on PubMed and the ClinicalTrials.gov record. Diagnosing and staging liver disease is a specialist task and we offer nothing on that here.
What the label says
- Indication: treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3) in adults, used with a reduced-calorie diet and increased physical activity.
- Accelerated approval: the label says this indication is approved under accelerated approval based on improvement of MASH and fibrosis, and that continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Dose: the recommended maintenance dosage for MASH is 2.4 mg injected subcutaneously once weekly; if 2.4 mg is not tolerated it can be lowered to 1.7 mg, with reescalation considered.
- Product: the label says the safety of Wegovy tablets and of the 7.2 mg injection has not been established in patients with MASH.
- Age: the Medication Guide says it is not known whether Wegovy injection is safe and effective for MASH in people under 18.
The ESSENCE trial results
Section 14.4 describes Study 11 (NCT04822181), a 240-week randomized, double-blind, placebo-controlled trial. Eligible patients had a baseline or recent liver biopsy showing MASH with fibrosis stage 2 or 3. The efficacy analysis at week 72 included the first 800 patients, randomized 1:2 to placebo (266) or Wegovy (534). The NEJM abstract notes that 1,197 patients were assigned in the full trial and that the week 72 results are an interim analysis of part 1. In the 800-patient analysis, 31% had F2 and 69% had F3 fibrosis, 56% had type 2 diabetes, and median BMI was 34.
| Week 72 endpoint (biopsy) | Placebo (n=266) | Wegovy (n=534) | Difference (95% CI, label) |
|---|---|---|---|
| Steatohepatitis resolved, no worsening of fibrosis | 34% | 63% | 29 points (21 to 36) |
| Fibrosis improved by 1 stage or more, no worsening of steatohepatitis | 22% | 37% | 14 points (8 to 21) |
| Both resolution and fibrosis improvement | 16% | 33% | 17 points (10 to 23) |
| Mean body weight change | -2.0% | -10.5% | -8.5 points (-9.6 to -7.4 per NEJM) |
The NEJM report gives the same results to one decimal place (62.9% versus 34.3%, 36.8% versus 22.4%, and 32.7% versus 16.1%). Biopsies were read independently by two pathologists with a third adjudicating disagreements. The label adds that starting at week 12, average ALT and AST showed a trend of greater reductions with Wegovy than placebo.
What these results do not show
This is where the accelerated approval wording matters. The week 72 endpoints are changes seen on liver biopsies. They are surrogate markers; the label itself says continued approval may depend on a confirmatory trial describing clinical benefit, and the trial is scheduled to run to 240 weeks. Neither the label nor the publication abstract reports cirrhosis, liver transplant or liver-related death results, so we do not either. Wegovy is also indicated only for noncirrhotic disease, so people with cirrhosis are outside the labelled use.
The population matters too. Only 3% of the week 72 analysis group (22 patients) had lean MASH (BMI under 25 for non-Asian patients), and the label notes that information is limited in patients with MASH and a BMI under 25. Few Black patients were enrolled (0.6%), and 68% of participants were White. Results in these groups are therefore less certain.
Safety notes specific to the MASH trial
Section 6.1 reports that the commonly reported adverse reactions in 1,195 treated MASH patients were consistent with the other Wegovy indications. Two findings from this trial are called out elsewhere in the label. Fractures occurred in 4.4% of Wegovy-treated patients (2.6 cases per 100 patient years) versus 3.3% on placebo. And lipase above three times the upper limit of normal occurred in 4.7% (35 of 750) of Wegovy patients versus 1.3% (5 of 374) on placebo; the label says the clinical significance is unknown. The general boxed warning and warnings for Wegovy continue to apply, and our label guides cover them: thyroid C-cell tumors, pancreatitis, gallbladder disease and kidney and liver impairment.
Mechanism, pregnancy and older adults
The label is candid about what is not understood. Section 12.1 says that for treatment of MASH in humans the precise mechanism of action of semaglutide is not fully understood and may involve multiple pathways mediated by weight loss and other factors, and that the relationship between animal-model MASH and human disease has not been fully established. In other words, the label does not claim the liver benefit is independent of weight loss, and we do not either; the average weight loss in the trial was 10.5%.
On pregnancy, the label separates its indications. For weight reduction or cardiovascular risk reduction, Wegovy is discontinued when pregnancy is recognized. For MASH, the label says the underlying liver disease with advanced fibrosis may carry risks to mother and fetus, that whether treatment reduces those risks is unknown, and that Wegovy for MASH should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It also advises discontinuing at least 2 months before a planned pregnancy where the risk outweighs the benefit, because of semaglutide’s long half-life. In the trial, 26% of Wegovy-treated patients (138 of 534) were 65 or older and 2% (13) were 75 or older; the label reports no overall differences in safety or effectiveness between older and younger adults with MASH, while noting that adults 75 and older reported more serious adverse reactions overall across the program.
One last practical point: the label’s indication for MASH applies to the injection. If you are comparing the injection with the Wegovy tablet, the label’s statement that tablet safety has not been established in MASH is the key difference, and our guide to oral GLP-1 versus injection covers the broader trade-offs.
Getting care and coverage
Because MASH is a biopsy- or imaging-staged liver diagnosis, care typically involves a hepatologist or gastroenterologist as well as a primary care prescriber. We did not verify any insurer’s MASH coverage rules or any price, so we offer none. For navigation, see our guide to prior authorization and appeals, the list of providers that accept insurance, the manufacturer’s own routes under official manufacturer programs, and the drug-level view in Ozempic vs. Wegovy vs. Zepbound. For people who first come to this drug through weight management, our online GLP-1 telehealth platform review lists services; none of these pages is a recommendation.
Questions to bring to your prescriber
- How was my liver disease staged, and do I fall within F2 to F3 without cirrhosis?
- Given that this is an accelerated approval, how will my liver be monitored over time?
- How do my other conditions, such as type 2 diabetes, and my other medicines factor in?
- Which formulation and dose does the label support for this use? (The label says tablets and the 7.2 mg injection are not established for MASH.)
Frequently asked questions
Is Wegovy approved for fatty liver?
It is approved for noncirrhotic MASH with moderate to advanced fibrosis (F2 to F3) in adults, under accelerated approval. The label does not list simple fatty liver without MASH.
Is MASH the same as NASH?
The label says MASH was formerly known as NASH.
Does the label say Wegovy prevents cirrhosis?
No. The label reports biopsy improvements at week 72 and notes that clinical benefit must be verified in a confirmatory trial.
What dose is used for MASH?
2.4 mg once weekly, or 1.7 mg if 2.4 mg is not tolerated.
Sources
- Novo Nordisk, Wegovy (semaglutide) injection and tablets prescribing information, revised 06/2026, sections 1, 2.2, 6.1, 14.4 and Medication Guide, fetched 14 October 2026.
- Sanyal AJ, et al. Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis. N Engl J Med, 5 June 2025 (PubMed 40305708), abstract read 14 October 2026.
- ClinicalTrials.gov NCT04822181: semaglutide in non-cirrhotic NASH (ESSENCE), status active, not recruiting, record read 14 October 2026.
Medical disclaimer. This article is informational, was prepared by the GLP-1.Reviews editorial team from the public sources listed above, and has not been reviewed by a physician. It is not medical advice. Label wording can change; confirm the instructions for your product with the Medication Guide that came with it. Talk to your prescriber or pharmacist about your own treatment, and see our medical disclaimer and editorial standards.
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