Novo Nordisk Says Wegovy Brought Liver Fat to Normal in Most of a Small MRI Group
Novo Nordisk presented a post hoc analysis in Milan showing 23 of 26 Wegovy users with high liver fat dropped below 5%, though the MRI group was small and had no control result.
Novo Nordisk says Wegovy (semaglutide) brought liver fat back to normal levels in nearly nine in ten people who started with too much of it, in a small imaging subgroup of a larger obesity trial. The company presented the analysis on Oct. 1 at the European Association for the Study of Diabetes (EASD) meeting in Milan.
The headline number comes with significant caveats, which are covered below.
What the analysis found
The data come from a post hoc analysis of the STEP UP trial programme, which tested semaglutide in adults with obesity. In a subgroup of 55 people who had MRI scans, average liver fat in the semaglutide group fell from 8.8% at the start to 3.1% at week 72, which Novo describes as a drop of nearly two-thirds.
Of the 26 participants who began with liver fat above 5%, 23 (88.5%) were below that threshold by week 72. Novo treats anything under 5% as normal.
The company pooled two doses, 7.2 mg and 2.4 mg, for this result.
Why the numbers need context
Mugglehead's reporting on the presentation points out several limits. Forty of the 55 MRI participants received semaglutide, and Novo's release gives no placebo MRI result, so the change describes the treated group only, not a difference against control. The presentation calls its analyses descriptive and gives no p value or confidence interval for the MRI finding.
Larger pooled data did include placebo comparisons. Across 1,919 adults in STEP UP and STEP UP T2D, median levels of the liver enzyme ALT fell by 16 units per litre on either dose, against 7.5 on placebo, among those with elevated baseline levels.
Among people rated high risk on the fatty-liver index, 42.9% on the higher dose moved to a lower risk category. The figure was 32.3% on the lower dose and 10.7% on placebo. That index relies on body measurements and blood tests, not a biopsy.
Normal fat on an MRI also does not show whether inflammation or scarring has reversed in someone with MASH, the more serious form of fatty liver disease.
Where Wegovy stands on liver disease
Wegovy at 2.4 mg is already approved for MASH in the United States, Canada, the United Kingdom, China and other markets. Novo says the 7.2 mg dose is not being studied for MASH, so the new analysis does not add an approved dose.
Singapore's Health Sciences Authority also approved Wegovy 2.4 mg for adults with noncirrhotic MASH and moderate to advanced fibrosis, Novo announced on Sept. 23. That decision rests on interim results from the ESSENCE trial. In that trial, 63% on semaglutide saw steatohepatitis resolve without worsening fibrosis, versus 34% on placebo at week 72.
ESSENCE enrolled 1,197 people. Results from its longer second part are expected in 2029.
What happens next
Novo Nordisk's U.S.-listed shares (NVO) closed at US$37.91 on Sept. 30. The company's next quarterly results are scheduled for Nov. 4.
Anyone with questions about liver health or treatment should speak to a doctor. The findings come from a company presentation.
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