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Enrolling by invitationPhase NA

Free Fatty Acid Effects In Type 2 Diabetes

Repositioning Omega-3 Fatty Acids For Treatment Of Glycaemia And Cardiometabolic Disease

Lead sponsor

University of Ulster

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

60

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 25-50

Primary endpoint

•Fasting glucose from baseline after 28 days of treatment

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07677995

Org study ID26/ES/0021

Secondary IDTA/PPA/25/215037British Heart Foundation

Timeline

Milestones

Study first posted2026-07-01actual

Last update posted2026-07-01actual

Study start2026-07estimated (month precision)

Primary completion2026-12estimated (month precision)

Study completion2027-02estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Individuals who are over 18 years of age with a BMI between 25-50 kg/m2, and who have been diagnosed with T2DM (>7.0 mmol/l fasting glucose) or pre-diabetes (impaired glucose tolerant 5.0-6.9mmol/l) and are either on no medication, are diet controlled or taking metformin. Participants may also have a history of cardiovascular disease.

Exclusion criteria

•Those who have severe or unstable cardiovascular disease

•Type 2 diabetics or prediabetics who are on an anti-diabetic medication (with the exception of metformin)

•Undergone recent major surgery or planned surgery during the study period

•Have implanted devices (such as pacemakers or defibrillators)

•Have an active infection

•Are involved in any other type of weight loss study/intervention

•Are pregnant/breastfeeding.

Endpoints (14)

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.

Coverage by outcome category

Glycemic / diabetes

6

Cardiometabolic biomarkers

4

Weight & body composition

2

MASH / liver

1

Other (unclassified)

1

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Body mass index (BMI) compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Waist-to-hip circumference compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

To evaluate the change in fasting glucose from baseline after 28 days of treatment, compared to each treatment group and placebo.

Time frame:From baseline to 28 days of treatment

change from baseline, improvement

Secondary/protocol endpoint

The change in insulin compared to placebo administration

Time frame:From baseline to 28 days of treatment

change from baseline, improvement

Secondary/protocol endpoint

The change in HbA1c compared to placebo administration

Time frame:From baseline to 28 days of treatment

change from baseline, improvement

Secondary/protocol endpoint

Glucose tolerance measurements during OGTT compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Area under the curve measurements during OGTT compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Liver function tests (ALT and AST) compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Full lipid profile (cardiovascular risk markers) compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Inflammatory and cardiovascular markers compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Blood pressure compared to placebo administration

Time frame:From baseline to 28 days of treatment

ratio, improvement

Secondary/protocol endpoint

Change in Omega-3 Index (EPA and DHA as a percentage of total fatty acids) compared to placebo administration

Time frame:From baseline to 28 days of treatment

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Plasma gut hormone concentrations (GLP-1, GIP, PYY, ghrelin, CCK and glucagon) compared to placebo administration

Time frame:From baseline to 28 days of treatment

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.