Wegovy remains the only GLP-1 approved for MASH as tirzepatide review continues

As of September 2026, Wegovy (semaglutide 2.4 mg weekly) remains the only GLP-1 medication with an FDA-approved indication for metabolic dysfunction-associated steatohepatitis (MASH), the liver disease formerly called NASH ^[1]. The agency approved the liver indication in August 2025 for adults with non-cirrhotic MASH and moderate-to-advanced fibrosis ^[1][2]. No other GLP-1, including tirzepatide (sold as Mounjaro and Zepbound), carries a MASH indication, so prescribing those drugs for MASH remains off-label ^[1].

What the label covers

Wegovy's MASH indication applies to adults 18 and older with confirmed MASH and fibrosis stage F2 or F3 on the NASH-CRN scale, meaning moderate fibrosis through advanced bridging fibrosis ^[1]. Cirrhosis, or stage F4, is excluded. The trial did not enroll patients with cirrhosis, and the FDA did not extend the approval beyond that population ^[1][2]. The indication has not been extended to adolescents, even though Wegovy is approved for weight management in patients as young as 12 ^[1].

There is no separate "MASH dose" of semaglutide. The label uses the same weekly titration — 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, then 2.4 mg maintenance — as the weight-management indication ^[1].

One distinction matters: the oral Wegovy tablet added to the label in June 2026 is indicated only for cardiovascular risk reduction and chronic weight management. It does not carry the MASH indication, because the ESSENCE trial tested the injection only ^[1].

The trial numbers behind the approval

ESSENCE was the phase 3 trial that supported the approval. The published report describes 1,197 adults with biopsy-confirmed MASH and fibrosis stage F2 or F3 who were randomly assigned to semaglutide 2.4 mg or placebo, both alongside lifestyle counseling ^[1]. The FDA's approval notice describes a planned week-72 interim analysis that included 800 participants, 534 on Wegovy and 266 on placebo ^[2].

At week 72, 62.9% of participants on semaglutide had MASH resolution without worsening fibrosis, compared with 34.3% on placebo ^[1]. The FDA rounds these figures to 63% and 34% ^[2]. Fibrosis improved by at least one stage without worsening MASH in 36.8% of the semaglutide group versus 22.4% of the placebo group ^[1]; the FDA gives 37% and 22% ^[2]. Average body-weight reduction was about 10.5% on semaglutide versus 2.0% on placebo ^[1].

Both co-primary endpoints were met ^[1]. The approval was granted under the accelerated pathway, based on biopsy findings rather than on outcomes such as death or liver transplant. As a result, continued approval may depend on a confirmatory trial showing clinical benefit ^[1][2].

Why it matters for patients

MASH often causes no symptoms until liver damage is advanced, and it can progress to cirrhosis, liver failure, liver cancer, the need for a transplant, or death. About 6% of U.S. adults — roughly 14.9 million people — are estimated to have it ^[2].

For labeling and coverage purposes, the approved indication is narrow. It requires documented MASH and fibrosis in the F2-F3 range; people with no or mild fibrosis (F0-F1) fall below the threshold, and people with cirrhosis fall outside it ^[1]. Insurers typically require a biopsy report or another accepted diagnostic pathway ^[1].

Patients taking tirzepatide for weight or diabetes should note that any MASH benefit would fall under off-label use, which can affect how a claim is handled, rather than an approved indication ^[1]. The new oral Wegovy tablet is not a substitute for the injection when the goal is treating MASH ^[1].

The most common side effects of Wegovy are gastrointestinal, including nausea, diarrhea, vomiting, constipation, abdominal pain and indigestion, along with headache and fatigue, according to the FDA. The label lists contraindications including a personal or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2, or a known sensitivity to semaglutide ^[2].

What happens next

ESSENCE is scheduled to continue for a total of 240 weeks to determine whether the improvements in inflammation and scarring seen at week 72 translate into fewer deaths, liver transplants and other liver-related events ^[2]. Those longer-term results have not been reported. Tirzepatide's MASH data remain under FDA review, and a decision timeline has not been reported ^[1].