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Lean-DM
CompletedPhase 4Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
57
actual
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≤25•HbA1c ≤10%
Primary endpoint
•Myocardial perfusion after treatment
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
Lean cohort
1. Men and women>18 years of age;
2. Normal body weight (18.5 ≤ BMI ≤25 kg/m2);
3. T2D patients can be on treatment with oral glucose lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening;
4. 6.5≤HBA1c≤10% at screening;
5. Agreement to maintain prior diet and exercise habits for the duration of the study.
Overweight cohort
1. Men and women>18 years of age;
2. Increased body weight (BMI >27 kg/m2);
3. T2D patients can be on treatment with oral glucose lowering therapies, and must have been on these treatments for at least 12 weeks prior to screening;
4. 6.5≤HBA1c≤10% at screening;
5. Agreement to maintain prior diet and exercise habits for the duration of the study.
Exclusion criteria
1. Any type of diabetes other than T2D;
2. Past history of significant CAD;
3. Known HF;
4. Significant renal impairment (eGFR<30ml/min/m2);
5. Participation in a clinical trial of an investigational medicinal product (CTIMP) in the preceding 12 weeks;
6. Known hypersensitivity to dobutamine or gadolinium or any other contra-indications to MRI;
7. Participants with obesity where their girth exceeds the scanner bore;
8. History of pancreatitis;
9. Any history of liver disease;
10. Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
11. Prior or current use of thiazolidinediones (aka PPAR-γ agonists), fibrates, GLP-1RA or insulin;
12. Patients that are pregnant (female participants only);
13. Inflammatory bowel disease
14. Diabetic gastroparesis
Endpoints (8)
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
Cardiovascular outcomes
1 endpointChange in myocardial perfusion after treatment
Time frame:40 weeks
change from baseline, improvement
Glycemic / diabetes
1 endpointInsulin resistance (HOMA-IR)
Time frame:40 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
MASH / liver
1 endpointHepatic steatosis (hepatic triglyceride content)
Time frame:40 weeks
Liver fat content, change
change from baseline, improvement
Heart failure
1 endpointPhysical performance
Time frame:40 weeks
6-minute walk distance
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointPeripheral endothelial function
Time frame:40 weeks
change from baseline, improvement
Other (unclassified)
3 endpointsMyocardial energetics (PCr/ATP ratio)
Time frame:40 weeks
change from baseline, descriptive
Myocardial steatosis (myocardial triglyceride content)
Time frame:40 weeks
change from baseline, improvement
Myocardial function
Time frame:40 weeks
change from baseline, improvement
Publications (1)
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
- Journal of the American College of Cardiology2024 Aug 6PMID39084829doi:10.1016/j.jacc.2024.04.064via clinicaltrials gov reference derived + pubmed nct search
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.