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Lirabolic

WithdrawnPhase 3

Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criterion

HbA1c ≥7%

Primary endpoint

Changes in the metabolomics profile (fold changes) between Liraglutide

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 IDNCT04057261
Org study ID17-162

Timeline

Milestones

Study first posted2019-08-15actual
Last update posted2021-03-10actual
Study start2020-11estimated (month precision)
Primary completion2022-08estimated (month precision)
Study completion2022-11estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Type 2 diabetes

2. Serum levels of HbA1c ≥ 7,0%

3. Age ≥ 18 years

4. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III)

5. Written informed consent prior to study participation

Exclusion criteria

1. Type 1 diabetes

2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors within the last 4 weeks

3. Patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary C-cell cancer

4. Renal impairment (eGFR < 30 mL/min)

5. Occurrence of acute vascular events within 6 weeks before screening and randomization

6. Known or suspected hypersensitivity to Liraglutide

7. Pregnant females as determined by positive (serum or urine) hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.

8. Lactating females

9. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.

10. The subject received an investigational drug within 30 days prior to inclusion into this study.

11. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.

12. The subject is unwilling or unable to follow the procedures outlined in the protocol.

13. The subject is mentally or legally incapacitated.

Endpoints (16)

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 (unclassified)
7
Cardiometabolic biomarkers
4
Heart failure
2
Weight & body composition
1
Glycemic / diabetes
1
Renal / kidney
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

body weight

Time frame:3 month

descriptive, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

changes of serum levels of glucose, HbA1c, glucagon, insulin, C-Peptide, β-Hydroxybutyrate between Liraglutide treatment group and placebo group

Time frame:3 month

change from baseline, improvement

Heart failure

2 endpoints
Secondary/protocol endpoint

change in left ventricular systolic function

Time frame:3 month

change from baseline, improvement

Secondary/protocol endpoint

Changes in NT-proBNP serum levels (pg/ml)

Time frame:3 month

NT-proBNP, change

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Albumin excretion

Time frame:3 month

ratio, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Changes in systolic and diastolic blood pressure (mmHg)

Time frame:3 month

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Differences of the serum lipid profile between Liraglutide treatment group and placebo group

Time frame:3 month

change from baseline, improvement

componentsTriglycerides, change, Total cholesterol, change, LDL-C, change, HDL-C, change

Secondary/protocol endpoint

Heart rate variability

Time frame:3 month

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

changes in inflammasome analyses

Time frame:3 month

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other (unclassified)

7 endpoints
Primary/protocol endpoint/low confidence

Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months

Time frame:3 month

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

change in left ventricular diastolic function

Time frame:3 month

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in left ventricular diastolic function

Time frame:3 month

change from baseline, improvement

componentse over e prime, left atrial volume

Secondary/protocol endpoint/low confidence

Resting energy expenditure

Time frame:3 month

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Respiratory Exchange Ratio

Time frame:3 month

descriptive

Secondary/protocol endpoint/low confidence

Differences in gut microbiome composition measured by 16S rRNA targeted gene sequencing of feces between Liraglutide treatment group and placebo group

Time frame:3 month

descriptive

Secondary/protocol endpoint/low confidence

Differences in circulation inflammatory cell composition by flow cytometry analyses (FACS) between Liraglutide treatment group and placebo group

Time frame:3 month

descriptive

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.