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ASCEND PLUS

RecruitingPhase 4

A Study of Cardiovascular Events iN Diabetes Plus

Lead sponsor

University of Oxford

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

20,000

estimated

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Expanded / custom MACE composite (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Expanded / custom MACE composite)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05441267

Org study IDCTSU_ASCEND-PLUS

Timeline

Milestones

Study first posted2022-07-01actual

Study start2023-03-13actual

Last update posted2024-05-08actual

Primary completion2028-08-17estimated

Study completion2048-08-17estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Adults aged at least 55 years at the time of the Screening assessment

•Type 2 Diabetes Mellitus (based on self-reported medical history)

Exclusion criteria

•Myocardial Infarction

•Stroke

•Current or planned treatment with a GLP-1 RA

•Previous hypersensitivity to or intolerance of GLP-1 RA therapy

•Severe hypoglycaemia within the last six months or during run-in

•Symptomatic hypoglycaemia within the last month

•Currently under consideration to commence insulin

•Severe heart failure (NYHA class 4)

•Current or planned renal replacement therapy

•Unwilling to complete regular follow-up assessments

•Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years

•Type 1 or other type of diabetes (e.g. MODY)

•History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

•Currently breastfeeding or pregnant, or planning a pregnancy

•Any serious illness which is likely to limit survival or active participation for at least 5 years

•Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes

•For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial

•Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally')

•Their doctor does not wish them to be randomised

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Cardiovascular outcomes

2 endpoints

Primary/protocol endpoint

Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE+)

Time frame:Scheduled treatment period (anticipated median follow-up period of 5-years)

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Expanded / custom MACE composite, Coronary revascularization

Secondary/protocol endpoint

Time to the first occurrence of a Major Adverse Cardiovascular Events (MACE)

Time frame:Scheduled treatment period (anticipated median follow-up period of 5-years)

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.