NCT05441267 (ASCEND PLUS) is a Phase 4 clinical trial of Semaglutide Oral Tablet in Diabetes Mellitus, Type 2, sponsored by University of Oxford.

Who is sponsoring NCT05441267?

NCT05441267 is sponsored by University of Oxford.

What drugs are being tested in NCT05441267?

Interventions in NCT05441267: Semaglutide Oral Tablet, Placebo oral tablet.

What condition does NCT05441267 study?

NCT05441267 studies Diabetes Mellitus, Type 2.

Is NCT05441267 still recruiting?

NCT05441267 is currently recruiting now. Last updated 8 May 2024.

Last reviewed 2024-05-08 · How we verify

NCT05441267: ASCEND PLUS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Cardiovascular Events iN Diabetes Plus

Recruiting now Phase 4 Last updated 8 May 2024

What this trial tests

Phase 4 trial testing Semaglutide Oral Tablet in Diabetes Mellitus, Type 2 in 20,000 participants. Currently enrolling.

Timeline

13 March 2023

Primary endpoint
17 August 2028

17 August 2048

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	20,000
Start date	13 March 2023
Primary completion	17 August 2028
Estimated completion	17 August 2048
Sites	1 location across United Kingdom

Drugs / interventions tested

Semaglutide Oral Tablet
Placebo oral tablet — full drug profile →

Conditions studied

Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

University of Oxford

Who can join

55 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

ASCEND PLUS is testing whether, for people with type 2 diabetes who have not previously had a heart attack or stroke, regularly taking a tablet called semaglutide can safely help to reduce heart attacks, strokes, mini-strokes, the need for any procedures to unblock or bypass an artery to their heart, and the chance of dying because of vascular problems.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Tirzepatide and prevention of chronic kidney disease.
Bosch C, Carriazo S, Soler MJ, Ortiz A, et al · · 2023 · cited 46× · PMID 37151412 · DOI 10.1093/ckj/sfac274
Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial.
El-Nayir M, Wijesurendra R, Preiss D, Mafham M, et al · · 2024 · cited 2× · PMID 39175005 · DOI 10.1186/s13063-024-08393-2
GLP-1-based therapeutics for cardiorenal protection in metabolic diseases.
Apperloo EM, Heerspink HJL, van Raalte DH, Muskiet MHA. · · 2026 · cited 1× · PMID 40560166 · DOI 10.1093/ndt/gfaf110
Real-World Comparisons Between Glucagon-Like Peptide-1 Receptor Agonists and Other Glucose-Lowering Agents in Type 2 Diabetes: Retrospective Analyses of Cardiovascular and Economic Outcomes in England.
Connolly D, Collins E, Ren H, Wan Yau Ming S, et al · · 2025 · cited 1× · PMID 40117087 · DOI 10.1007/s13300-025-01715-w
Cardiovascular and kidney benefits of GLP-1 receptor agonists across large randomized placebo-controlled trials.
Yoshiji S, Inagaki N. · · 2025 · PMID 41047752 · DOI 10.1111/jdi.70166

Verify or expand the search:

Other trials of Semaglutide Oral Tablet

Trials testing the same drug.

NCT07391267 — Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and · NA · not yet recruiting
NCT05147896 — Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients · NA · unknown

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

NCT07415954 — A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 · Phase 2 · recruiting
NCT07532863 — A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Part · recruiting
NCT07336329 — Continuous Glucose Monitoring in Non-Insulin Treated Type 2 Diabetes: Continuous vs. Periodic Use · NA · recruiting
NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
NCT07444203 — Transformative Research in Diabetic Nephropathy 2.0 · recruiting

Other University of Oxford trials

Trials by the same sponsor.

NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05441267 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Oxford
Last refreshed: 8 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05441267.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing