COPENHAGEN, Nov 5 (Reuters) - Wegovy-maker Novo Nordisk

presented new data on Wednesday showing its experimental

weight-loss pill improved blood sugar control and reduced

cardiovascular risk factors, bolstering the Danish drugmaker's

case for the treatment ahead of an expected U.S. approval by

year-end.

If that goes ahead, the pill would be the first oral GLP-1

treatment approved for weight management.

New analyses from the OASIS 4 clinical trial, presented at

ObesityWeek 2025 in Atlanta, showed oral semaglutide 25 mg

delivered cardiovascular benefits and weight loss comparable to

the company's blockbuster injectable Wegovy.

NOVO WAITING FOR US APPROVAL OF PILL BY YEAR-END

The U.S. Food and Drug Administration (FDA) accepted Novo's

application for oral Wegovy in May and is expected to decide by

the end of the fourth quarter. Novo has said it expects approval

and plans to launch soon after.

Novo trimmed its full-year profit and sales forecasts on

Wednesday as sales growth stalled, but investors cheered a

better-than-expected Medicare pricing deal.

Novo is going through a tumultuous period marked by a share

price plunge and slowing sales growth, which have prompted a

change of CEO and a board shake-up.

In the analysis, 71.1% of participants with prediabetes who

took the pill achieved normal blood glucose at 64 weeks,

compared with 33.3% on placebo. Patients who lost at least 15%

of their body weight saw greater improvements in blood pressure

and reductions in inflammatory markers and triglycerides.

An indirect comparison between the OASIS 4 trial and the

earlier STEP 1 trial of injectable Wegovy showed that the oral

and injectable formulations delivered comparable results on

weight loss targets and cardiometabolic markers.

Novo has said it plans to make the pill available through

telehealth platforms including Ro and WeightWatchers, once

approved. The company is also considering a subscription model

with discounted pricing.

Hims & Hers Health said last week it was in talks with Novo

to offer both injectable and oral Wegovy through its platform.

The pill showed 16.6% weight loss in the primary OASIS 4

results published in September in the New England Journal of

Medicine.