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Lirabolic
WithdrawnPhase 3Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointbody weight
Time frame:3 month
descriptive, improvement
Glycemic / diabetes
1 endpointchanges 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 endpointschange in left ventricular systolic function
Time frame:3 month
change from baseline, improvement
Changes in NT-proBNP serum levels (pg/ml)
Time frame:3 month
NT-proBNP, change
change from baseline, improvement
Renal / kidney
1 endpointAlbumin excretion
Time frame:3 month
ratio, improvement
Cardiometabolic biomarkers
4 endpointsChanges in systolic and diastolic blood pressure (mmHg)
Time frame:3 month
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
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
Heart rate variability
Time frame:3 month
Heart rate, change
change from baseline, improvement
changes in inflammasome analyses
Time frame:3 month
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Other (unclassified)
7 endpointsChanges 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
change in left ventricular diastolic function
Time frame:3 month
change from baseline, improvement
change in left ventricular diastolic function
Time frame:3 month
change from baseline, improvement
componentse over e prime, left atrial volume
Resting energy expenditure
Time frame:3 month
change from baseline, descriptive
Respiratory Exchange Ratio
Time frame:3 month
descriptive
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
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 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.