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LIONESS

CompletedPhase 2

Liraglutide to Improve corONary Haemodynamics During Exercise streSS

The Physiological Effects of GLP-1 on Haemodynamics During Exercise in Patients With Ischaemic Heart Disease

Lead sponsor

King's College London

Assets

GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Cardiovascular disease

Key I/E criterion

—

Primary endpoints

•Rate pressure product at 0.1 mV ST-segment depression•Degree of ST-segment depression at peak exercise

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 IDNCT02315001

Org study IDRJ112/N131

Secondary IDFS/11/70/28917British Heart Foundation

Timeline

Milestones

Study first posted2014-12-11estimated

Last update posted2015-05-20estimated

Study start2014-01 (month precision)

Primary completion2015-03actual (month precision)

Study completion2015-03actual (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Cardiovascular disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Men and women aged 18-80

2. Patients with a recent abnormal exercise tolerance test demonstrating >0.1 mV of planar or down-sloping ST-segment depression.

3. Patients with known coronary artery disease and angiographic evidence of a >70% stenosis in a main epicardial artery, with or without coronary stenoses elsewhere.

4. Patients must be able to walk confidently on a treadmill.

5. Patients must have a normal resting electrocardiogram (ECG) in sinus rhythm without bundle branch aberration or other conduction disturbance.

6. Patients must have normal left ventricular function.

Exclusion criteria

1. An abnormal resting ECG including atrial fibrillation, bundle branch aberration or other conduction disturbance.

2. Pre-existing left ventricular systolic dysfunction.

3. Pre-existing ischaemic or non-ischaemic cardiomyopathy.

4. Pre-existing valvular heart disease.

5. Inability to safely negotiate an exercise treadmill.

6. Type I diabetes mellitus.

7. Type II diabetes mellitus taking oral or subcutaneous anti diabetic therapy.

Endpoints (9)

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

Other clinical outcomes

Safety / tolerability / PK

Renal / kidney

Cardiometabolic biomarkers

Other (unclassified)

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Evidence of renal dysfunction

Time frame:During 6-week study protocol

eGFR, change

change from baseline, descriptive

LOINC 98979-8

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint/low confidence

Change in rate pressure product at 0.1 mV ST-segment depression

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Evidence of hypoglycaemia

Time frame:During 6-week study protocol

Documented hypoglycemia

descriptive, event

Secondary/protocol endpoint

Evidence of acute pancreatitis

Time frame:During 6-week study protocol

Pancreatitis

categorical status, event

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Change in degree of ST-segment depression at peak exercise

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Secondary/protocol endpoint

Change in total exercise duration

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in recovery time to 0.05 mV ST-segment depression

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Secondary/protocol endpoint

Change in time to maximum ST-segment depression

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in time to 0.1 mV ST-segment depression

Time frame:Following consecutive exercise treadmill tests performed at Week 2, Week3, Week 5 and Week 6 of a 6-week study protocol

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS): a double-blind randomised placebo-controlled crossover trial.
Diabetology & metabolic syndrome2021 Feb 12PMID33579317doi:10.1186/s13098-021-00635-6via clinicaltrials gov reference derived + pubmed nct search
Design and rationale for the randomised, double-blinded, placebo-controlled Liraglutide to Improve corONary haemodynamics during Exercise streSS (LIONESS) crossover study.
Cardiovascular diabetology2015 Feb 19PMID25848859doi:10.1186/s12933-015-0193-4via CT.gov background + pubmed nct search

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.