← Trials/Trial dossier/NCT04657939

Lean-DM

CompletedPhase 4

Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes

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 ≤25HbA1c ≤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

NCT IDNCT04657939
Org study ID265208
Secondary ID18/0005908Diabetes UK
Secondary ID19/WM/0365West Midlands- Black Country Research Ethics Committee

Timeline

Milestones

Study start2020-12-01actual
Study first posted2020-12-08actual
Primary completion2022-10-31actual
Study completion2022-10-31actual
Last update posted2023-02-27actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
3
Cardiovascular outcomes
1
Glycemic / diabetes
1
MASH / liver
1
Heart failure
1
Cardiometabolic biomarkers
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Change in myocardial perfusion after treatment

Time frame:40 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Insulin resistance (HOMA-IR)

Time frame:40 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Hepatic steatosis (hepatic triglyceride content)

Time frame:40 weeks

Liver fat content, change

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Physical performance

Time frame:40 weeks

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Peripheral endothelial function

Time frame:40 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Myocardial energetics (PCr/ATP ratio)

Time frame:40 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Myocardial steatosis (myocardial triglyceride content)

Time frame:40 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

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.