GLP-1 Peptide Atlas, by Delfa

CompletedPhase NA

The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

A Randomised, Double-blind, Placebo-controlled Study of the Effect of LIraglutide on Left VEntricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes (The LIVE-study)

Lead sponsor

Flyvbjerg, Allan, DMSc

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

240

actual

Study population

Heart failure, Type 2 diabetes

Key I/E criterion

•EF ≤45%

Primary endpoint

•Left ventricular function from visit 1

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 IDNCT01472640

Org study IDDKprotokol(LIVE)v5

Secondary ID2011-002468-26

Timeline

Milestones

Study first posted2011-11-16estimated

Last update posted2015-10-12estimated

Study start2011-11 (month precision)

Primary completion2015-09actual (month precision)

Study completion2015-10actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Heart failureType 2 diabetes

Eligibility

Who can enroll

Minimum age30 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Able to understand the written patient information and to give informed consent

•CHF, NYHA-class I, II or III at visit 0

•LVEF ≤45 %

•Age 30 to 85 (both inclusive)

•Stable pharmacological treatment of heart failure according to ESC guidelines for the last 3 months prior to randomisation (visit 1)

For patients with diabetes exclusively:

•T2D (WHO criteria), diagnosed at least 3 months prior to visit 0

•Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs

•Stable and optimal dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)

Exclusion criteria

•Myocardial infarction (MI), unstable angina or coronary revascularization within the last three months prior to visit 1

•Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1)

•CHF (NYHA class IV)

•ECG suggestive of malign ventricular arrhythmia at visit 0

•Type 1 diabetes

•HbA1c > 10% measured at visit 0

•Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1)

•Known or suspected hypersensitivity to trial product or related products

•Alcohol/drug abuse

•Pregnant or nursing women

•Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives

•Cancer unless in complete remission for ≥5 years

•Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)

•Inflammatory bowel disease

•Acute or chronic pancreatitis

•Gastroparesis

•Compromised kidney function (eGFR < 30 ml/min), dialysis or kidney transplantation

•History of thyroidea adenoma or carcinoma

•Severely elevated blood pressure (systolic >180 mmHg and/or diastolic >105 mmHg)

•Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation

•Simultaneous participation in any other clinical intervention trial

•Receipt of an investigational drug with 30 days prior to visit 0

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.

Heart failure

2 endpoints

Primary/protocol endpoint

Change in Left ventricular function from visit 1 to week 24, measured by Ecco

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

left ventricular diastolic function

Time frame:24 weeks

descriptive

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

Effect of liraglutide on myocardial glucose uptake and blood flow in stable chronic heart failure patients: A double-blind, randomized, placebo-controlled LIVE sub-study.
Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology2019 Apr (month)PMID28770459doi:10.1007/s12350-017-1000-2via clinicaltrials gov reference derived + pubmed nct search
A protocol for a randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE Study).
BMJ open2014 May 20PMID24844271doi:10.1136/bmjopen-2014-004885via clinicaltrials gov reference derived + 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.