Evidence map›Paper›PMID 42023428›Full record

ArticleDiabetes, obesity & metabolism2026

Efficacy, Safety and PK of Once-Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model-Informed Drug Development Approach.

Rune Viig Overgaard, Oscar Birkhan, Naveen Rathor, Thomas Sparsø, Anders Strathe, Sean Wharton, Domenica Rubino

Abstract readComparative Study
In one paragraph

Article in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Rune Viig OvergaardNovo Nordisk A/S, Søborg, Denmark.ORCID 0000-0001-7095-4270
Oscar BirkhanNovo Nordisk A/S, Søborg, Denmark.ORCID 0000-0002-7554-5035
Naveen RathorNovo Nordisk A/S, Søborg, Denmark.
Thomas SparsøNovo Nordisk A/S, Søborg, Denmark.
Anders StratheNovo Nordisk A/S, Søborg, Denmark.ORCID 0000-0002-1598-2591
Sean WhartonUniversity of Toronto, York University, McMaster University, Wharton Weight Management Clinic, Burlington, Ontario, Canada.ORCID 0000-0003-0111-1530
Domenica RubinoWashington Center for Weight Management and Research, Arlington, Virginia, USA.

Funding

Novo Nordisk A/S
6 · The paper itself

Abstract

aimsSemaglutide has previously been approved for weight management and cardiovascular disease as a subcutaneous formulation, and more recently also as an oral formulation. However, there is limited information across oral dose levels, and there are no studies for the 25 mg dose in people with obesity and type 2 diabetes (T2D). To fulfil health authority approval requirements, population pharmacokinetic and exposure-response analyses were used to extrapolate efficacy and safety data from subcutaneous to oral semaglutide. MATERIALS AND

methodsOnce-daily oral semaglutide 25 mg was approved for obesity treatment based on historical semaglutide data and the OASIS programme. Two studies were simulated: a modelled/virtual Phase 2 trial to establish efficacy across different oral semaglutide dose levels, and a modelled/virtual Phase 3 trial to assess efficacy in a population with overweight/obesity and T2D.

resultsMost participants (82.2%) treated with oral semaglutide 25 mg in OASIS 4 achieved exposure levels within the same range as participants treated with once-weekly subcutaneous semaglutide 2.4 mg in STEP 1. In the simulated studies, oral semaglutide 25 mg provided significantly greater weight reduction compared with placebo, for the trial product estimand and treatment policy estimand, respectively, in those with overweight/obesity and T2D (9.4% and 7.8%), and in those with overweight/obesity without T2D (16.3% and 14.7%).

conclusionsEstimated exposure levels and efficacy observed with oral semaglutide 25 mg were similar to those obtained with subcutaneous semaglutide 2.4 mg, supporting application of oral semaglutide 25 mg to treat individuals with overweight/obesity, with/without T2D.

Indexed as

Anti-Obesity AgentsDiabetes Mellitus, Type 2Hypoglycemic AgentsObesitySemaglutideAdministration, OralAdultDrug Administration ScheduleDrug DevelopmentFemaleHumansInjections, SubcutaneousMaleMiddle AgedTreatment OutcomeWeight LossAnti-Obesity AgentsHypoglycemic AgentsSemaglutideGLP‐1 analoguepharmacokineticssemaglutidetype 2 diabetesweight management

Identifiers

PMID42023428
PMCPMC13243942

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.