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Reuters Health Information: CORRECTED-Semaglutide effective against nonalcoholic steatohepatitis in phase-2 trial

CORRECTED-Semaglutide effective against nonalcoholic steatohepatitis in phase-2 trial

Last Updated: 2020-11-16

(Adds "and advanced fibrosis" to paragraph 15.)

By Gene Emery

NEW YORK (Reuters Health) - Semaglutide injections resolved nonalcholic steatohepatitis (NASH) with no worsening of fibrosis in up to 59% of patients compared to 17% for patients getting placebo, according to a new phase-2 trial.

The results were reported at the American Association for the Study of Liver Disease's annual meeting and in the New England Journal of Medicine.

"These are very promising data," chief author Dr. Philip Newsome, a professor of hepatology at the University of Birmingham in the United Kingdom, told Reuters Health by phone.

"The primary outcome was improvement of liver injury. Almost 60% achieved that when they received the highest dose of semaglutide. That's very impressive," he said.

The highest dose was 0.4 mg per day given over 72 weeks. The rates of resolution were 36% with 0.2 mg and 40% with 0.1 mg.

The drug did not produce significant improvement in the stage of fibrosis, which was a surprising finding as previous research had suggested fibrosis might regress.

But it did cause patients in the highest-dose group to drop a mean of 13% of their weight, compared to 1% with placebo.

The 320 patients in the randomized trial were treated at 143 sites in 16 countries. People with and without diabetes were enrolled. All had a BMI above 25. All had stage F2 or F3 fibrosis.

The improvements came at a cost. Compared to placebo, the rate of nausea was 31 percentage points higher with the 0.4 mg dose (at 42%), the rate of constipation was 10 percentage points greater (22% with the drug) and vomiting was more than seven times more common with semaglutide (15% vs. 2%).

"This drug is already in widespread clinical use for the management of diabetes," so the side effects are well known, Dr. Newsome said. "Those feelings of nausea and vomiting peak and then start to settle in a large proportion of patients. There is an element of bearing-with-it and the understanding that, over time, your body adjusts and the symptoms will be reduced. The tradeoff is that patients will see substantial weight loss with it, and for many patients that's a significant motivating factor."

Neoplasms - benign or malignant, including cysts and polyps - were seen in 15% of the semaglutide patients compared to 8% of placebo recipients. Three patients on semaglutide had malignant neoplasms versus none in the placebo group.

"No pattern of occurrence in specific organs was observed," the researchers note.

The rate of discontinuation of treatment due the side effects was 7% with the drug versus 5% with placebo.

Novo Nordisk, which sells semaglutide as a diabetes treatment under the brand name Ozempic, paid for the study. Based on the per-milliliter list price on the website, the cost of treatment in the new study, using the highest dose, would exceed $80,000.

Dr. Newsome estimated that 0.5% of the population has some degree of NASH and advanced fibrosis, for which there is no approved therapy.

Worsening fibrosis was seen in 10% of patients with the low dose, 8% with the middle dose and 5% with the highest dose. The rate among placebo patients was 19%.

"It is possible that the current trial was not of sufficient duration for improvements in fibrosis stage to become apparent, especially since most of the patients had advanced fibrosis," the researchers note.

SOURCE: The New England Journal of Medicine, online November 13, 2020.

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