Research and trials

Novo Nordisk presents four analyses of oral semaglutide 25 mg at ObesityWeek 2025

New analyses of a daily semaglutide pill showed blood sugar and blood pressure changes alongside weight loss in a 64-week trial, ahead of US approval of the pill in December 2025.

By the Semaglutides news desk·
Novo Nordisk presents four analyses of oral semaglutide 25 mg at ObesityWeek 2025
Image: appliedclinicaltrialsonline.com

Novo Nordisk presented four new analyses of oral semaglutide 25 mg at ObesityWeek 2025 on Nov. 5, covering heart and metabolic outcomes beyond weight loss. The company said the data supported its application then under review by the US Food and Drug Administration for a weight-loss pill [1][2].

The analyses came from OASIS 4, a 64-week randomized, double-blind, placebo-controlled trial of once-daily oral semaglutide 25 mg. The trial enrolled 307 adults with obesity or overweight plus at least one weight-related condition, and excluded people with diabetes. Participants were assigned 2:1 to the drug or placebo, with a 12-week dose-escalation phase, a lifestyle intervention for everyone, and a seven-week follow-up after treatment stopped [2].

What the new analyses showed

In a post hoc analysis of blood sugar and cardiovascular risk factors, 71.1% of participants who had prediabetes at the start of the trial reached normal blood glucose by week 64 in the semaglutide group, compared with 33.3% in the placebo group. Within the semaglutide group, participants who lost at least 15% of their body weight had larger average reductions in blood pressure: 10.1 mmHg versus 4.1 mmHg for systolic pressure, and 4.3 mmHg versus 1.1 mmHg for diastolic pressure [2].

A separate pooled post hoc analysis of OASIS 4 and the STEP trials reported weight loss across menopause stages: 18.2% in pre-menopausal participants, 15.0% in peri-menopausal participants and 15.7% in post-menopausal participants [2].

These analyses add to the trial's topline results, which were published in September 2025. With full adherence, oral semaglutide 25 mg produced 16.6% mean weight loss at 64 weeks, compared with 2.7% for placebo. In the treatment-policy analysis, which counted all participants regardless of whether they stayed on treatment, weight loss was 13.6% versus 2.2%. Serious adverse events occurred in 3.9% of people taking the drug and 8.8% of those taking placebo [2].

The company has not disclosed whether the four analyses presented at ObesityWeek have been peer-reviewed or published in full, and the presentations did not test whether the pill reduces heart attacks or strokes. The blood sugar and blood pressure findings come from post hoc analyses, meaning they were examined after the trial ended rather than set in advance as primary goals.

Why it matters for patients

For people weighing whether to start a GLP-1 medication, a daily pill is a different proposition from a weekly injection. Wegovy is already sold as an injection and, since the December 2025 approval, as tablets in 1.5 mg, 4 mg, 9 mg and 25 mg strengths taken once daily on an empty stomach [1]. The tablet carries the same boxed warning for thyroid C-cell tumors as the injection, along with warnings for pancreatitis, gallbladder disease, low blood sugar and other risks [1].

Patients who track blood sugar or blood pressure may find these analyses relevant, because the reported changes go beyond the number on a scale. The prediabetes finding applies only to people with prediabetes at the start of the trial, and the trial excluded people with diabetes, so the results do not describe that group [2].

The blood pressure figures describe differences between people who lost more weight and those who lost less within the semaglutide group, not a comparison against placebo alone [2].

What happens next

The FDA approved Novo Nordisk's Wegovy pill on Dec. 22, 2025, making it the first oral GLP-1 for weight loss in adults. The approval also covers reducing the risk of major adverse cardiovascular events, including cardiovascular death, heart attack or stroke [1][2].

Novo said it planned a full US launch in early January 2026, with manufacturing underway at its North Carolina facilities [2]. The company also submitted the oral formulation to the European Medicines Agency and other regulators in the second half of 2025; the timing of those decisions has not been disclosed [2].

Sources

  1. https://www.drugs.com/history/wegovy.html
  2. https://www.appliedclinicaltrialsonline.com/view/fda-approves-oral-wegovy-positive-oasis-trial-results

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