Wegovy for MASH: What the FDA Label and ESSENCE Show (2026)

What the Wegovy for MASH Indication Says

MASH stands for metabolic dysfunction-associated steatohepatitis. The Wegovy label describes it as "formerly known as nonalcoholic steatohepatitis (NASH)", so older articles about Wegovy for NASH refer to the same condition. Here is how FDA worded the indication, and the condition section 1 of the Wegovy prescribing information attaches to it:

In section 1 of the label, this use sits under the opening condition that Wegovy injection is used "in combination with a reduced calorie diet and increased physical activity".

Because it requires F2 or F3 fibrosis, MASH with no or mild fibrosis (F0 to F1) is outside the indication. It also leaves out three groups:

• People with cirrhosis. The indication covers noncirrhotic disease only. The Medication Guide puts it as moderate to advanced liver scarring without cirrhosis.
• Wegovy tablets. The label states that safety and effectiveness of Wegovy tablets have not been established in patients with MASH (section 6.1). More on the oral version in our Wegovy pill guide.
• Children and teens. The MASH indication is written for adults, and section 8.4 states that safety and effectiveness of Wegovy injection have not been established in pediatric patients for the treatment of noncirrhotic MASH.

F2 and F3 are biopsy fibrosis stages; the label groups them as "moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)". The MASH indication lists no BMI requirement.

What accelerated approval means here

The FDA approval letter for supplemental application NDA 215256/S-024 grants the MASH indication under section 506(c) of the Federal Food, Drug, and Cosmetic Act, effective August 15, 2025. Accelerated approval lets FDA approve a drug on a marker reasonably likely to predict clinical benefit, here liver tissue changes on biopsy, while the actual benefit is still being confirmed.

The letter attaches postmarketing requirement 4882-1: a 240-week trial, NN9931-4553, measuring progression to cirrhosis, hepatic decompensation events, liver transplant and death, with completion due 06/2029 and the final report 12/2029. ClinicalTrials.gov lists NN9931-4553 as the sponsor ID of ESSENCE (NCT04822181), so the confirmatory trial is ESSENCE itself.

Where else it is approved

In the European Union, the European Medicines Agency granted Kayshild (semaglutide) a conditional marketing authorisation on March 26, 2026 for adults with non-cirrhotic MASH and F2 to F3 fibrosis, alongside diet and exercise. The EU brand for MASH is Kayshild, not Wegovy.

How Wegovy Is Dosed for MASH

Section 2.2 of the label sets the MASH maintenance dose at 2.4 mg injected under the skin once weekly. If a patient does not tolerate 2.4 mg, the dose can drop to 1.7 mg once weekly, and the label says to consider going back up to 2.4 mg. The starting steps come from Table 1, which applies to every Wegovy injection indication:

Dose steps from Wegovy prescribing information section 2.2 and Table 1 (DailyMed version 19). Your prescriber may move more slowly.

In ESSENCE, patients reached 2.4 mg during the first 16 weeks, though escalation could be stretched out, or a patient could stay on a lower dose, if 2.4 mg was not tolerable (label section 14.4).

The label's 7.2 mg option is for weight reduction in adults only; for MASH, 2.4 mg is the top dose. Our semaglutide dosage chart sets the indications side by side, and the Wegovy calculator models the weekly steps.

What the ESSENCE Trial Found

Trial design and who was in it

ESSENCE (NCT04822181, called Study 11 in the label) is a phase 3, randomized, double-blind, placebo-controlled trial planned to run 240 weeks, funded by Novo Nordisk. Everyone entering had MASH on liver biopsy plus F2 or F3 fibrosis. ClinicalTrials.gov lists 1,205 people enrolled.

The approval rests on part 1: an interim analysis of the first 800 patients at week 72. Of those, 250 (31%) had F2 and 550 (69%) had F3 fibrosis. They were randomized 1:2 to placebo (266) or Wegovy 2.4 mg (534). Median age was 57, 57% were women, median BMI was 34, and 56% had type 2 diabetes.

Week-72 liver biopsy results

Source: Sanyal et al., N Engl J Med 2025;392:2089-2099 (ESSENCE part 1, Novo Nordisk-funded). The Wegovy label reports the same endpoints rounded to whole numbers in its Table 21.

Interim week-72 biopsy results (part 1), 800 adults with noncirrhotic MASH and F2 or F3 fibrosis. All three comparisons P<0.001. Figures from the NEJM paper (2025). Differences are pooled Mantel-Haenszel estimates stratified by type 2 diabetes status and fibrosis stage, with missing data handled by reference-based multiple imputation, per label section 14.4. Because the differences are model estimates, they can differ slightly from simple subtraction of the two percentages.

Biopsies were graded on the MASH CRN system by two pathologists, with a third settling disagreements (label section 14.4). "Resolution" meant lobular inflammation scored 0 or 1 and no hepatocyte ballooning; some fat could remain. Over the same 72 weeks, mean body weight fell 10.5% on Wegovy versus 2.0% on placebo (NEJM).

What the trial has not shown yet

Biopsy changes are a surrogate. Part 2 of ESSENCE continues to 240 weeks to test whether Wegovy reduces progression to cirrhosis, liver decompensation, transplant and death. As of November 5, 2026, we found no published results for part 2 in PubMed or on the ClinicalTrials.gov record, which lists estimated primary completion in April 2029. In its August 15, 2025 approval announcement, Novo Nordisk said part 2 is expected to read out in 2029.

The label makes the same point about blood and imaging markers. Section 12.2 states that semaglutide decreases liver fat (MRI-PDFF), liver stiffness and two fibrosis markers (ELF score and Pro-C3), then adds: "The clinical relevance of these changes is yet to be confirmed."

How Wegovy Works in MASH

The label does not pin it down. Section 12.1 of the label states: "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."

Beyond weight loss, the label names no specific liver mechanism, and neither does this page. For semaglutide's general actions, see how semaglutide works.

Safety in the MASH Trial

Label section 6.1 bases its MASH safety data on 1,195 adults in ESSENCE: 800 took Wegovy for a median of 95.3 weeks and 395 took placebo for a median of 83.1 weeks. The label says the most common adverse reactions matched those seen in the other Wegovy indications, which are mainly gastrointestinal. Stomach tips are in our nausea management guide.

Label section 6.1 gives two MASH-specific adverse-event rates:

• Lipase. Lipase above 3 times the upper limit of normal occurred in 4.7% (35/750) on Wegovy versus 1.3% (5/374) on placebo. Without other signs of pancreatitis, the label says the meaning of this is unknown.
• Fractures. Fractures occurred in 4.4% on Wegovy (2.6 per 100 patient-years) versus 3.3% on placebo (2 per 100 patient-years). Our semaglutide and bone article covers what this does and does not mean.

The label notes limited information in MASH patients with a BMI under 25. For MASH in pregnancy, it says to use Wegovy only if the potential benefit justifies the potential risk to the fetus. The full side-effect list is in our semaglutide side effects guide.

Wegovy for MASH Versus Other Options

Rezdiffra (resmetirom)

Rezdiffra, from Madrigal Pharmaceuticals, is approved for the same group: adults with noncirrhotic MASH and moderate to advanced fibrosis (consistent with F2 to F3), with diet and exercise. Its approval is also accelerated. The two drugs differ in class and form. Rezdiffra is an oral tablet that acts on the thyroid hormone receptor-beta, while Wegovy is a weekly GLP-1 injection.

We cite no head-to-head trial and do not set their trial percentages side by side, because the trials differ in design and analysis. The choice belongs to a liver specialist.

Tirzepatide (Zepbound and Mounjaro)

Our text search of the Zepbound and Mounjaro prescribing information on November 5, 2026 found no mention of MASH or steatohepatitis. In the phase 2 SYNERGY-NASH trial (190 adults with biopsy-confirmed MASH and F2 to F3 fibrosis, 52 weeks), all three tirzepatide doses achieved resolution of MASH without worsening of fibrosis more often than placebo (Loomba et al., NEJM 2024). SYNERGY-Outcomes (NCT07165028), a phase 3 trial of retatrutide and tirzepatide in adults with MASLD at increased risk of major adverse liver outcomes, was listed as recruiting on ClinicalTrials.gov on November 5, 2026.

Phase 2 results at 52 weeks and phase 3 interim results at 72 weeks cannot be compared as percentages. Our Wegovy vs Zepbound comparison covers the weight-loss head-to-head.

Who Qualifies and How It Is Decided

On paper, the label population is short: adults, MASH, F2 or F3 fibrosis, no cirrhosis. ESSENCE confirmed MASH and the fibrosis stage by biopsy. In practice, the November 2025 AASLD practice guidance update on semaglutide for MASH describes selecting patients with non-invasive tests, such as vibration-controlled transient elastography (VCTE), magnetic resonance elastography (MRE) and the Enhanced Liver Fibrosis (ELF) blood test, rather than relying on biopsy.

Staging and eligibility are decisions for a hepatologist or the prescriber treating your liver, not something to work out from a scan report at home.

Coverage and Cost for MASH

Medicare treats noncirrhotic MASH with moderate to advanced fibrosis as a Part D indication, not a weight-loss use. In CMS's words, beneficiaries with these diagnoses "are eligible to receive GLP-1s through their Part D plan and therefore are ineligible to receive them through the Medicare GLP-1 Bridge". More on the Bridge is in our TrumpRx pricing guide.

Commercial coverage varies by plan, and we could not verify a universal rule. Plans may require prior authorization, so check your formulary. For prices and savings options, see Wegovy GoodRx vs savings card and semaglutide cost, which carry their own dated price checks.