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GLIMP

CompletedPhase 2Results posted

Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Effects of Glucagon-Like Peptide-1 Agonists on Metabolism and Ectopic Fat Deposition in Chronic Kidney Disease: A Pilot and Feasibility Study

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

7

actual

Study population

Chronic kidney disease, Obesity / overweight

Key I/E criterion

eGFR 15-59

Primary endpoints

Changes in Intermuscular Fat DepositionChanges in Skeletal Muscle Mitochondrial FunctionChanges in Physical Performance

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 IDNCT05254418
Org study ID220057

Timeline

Milestones

Study first posted2022-02-24actual
Study start2022-03-15actual
Primary completion2024-05-01actual
Study completion2024-08-01actual
Last update posted2025-04-20actual
Results first posted2025-04-20actual

Assets

Investigational agents

Study populations

Who this study enrolls

Chronic kidney diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)

2. Age ≥ 18 years and ≤75 years

Exclusion criteria

1. Patients with type 1 diabetes mellitus

2. Patients with T2D who are on insulin therapy or who started a new antidiabetic medication within 1 month prior to study or who received incretin-based therapy within 3 months prior to study

3. BMI <25 kg/m2, BMI >40 kg/m2

4. HbA1c>8% measured within 1 month prior to study, or a history of hypoglycemic episode within 1 year prior to study, or a history of diabetic ketoacidosis

5. Uncontrolled hypertension (>200/100 mmHg) despite optimal antihypertensive therapy

6. Arrythmia, heart failure (NYHA class III-IV), valve disease or heart diseases other than coronary artery disease

7. History of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis

8. Personal or family history of medullary thyroid cancer, or personal history of Multiple Endocrine Neoplasia (MEN)-2

9. Pregnancy, breast feeding or intention to become pregnant

10. Previous renal transplantation

11. Acute or chronic infectious diseases

12. Cancer or chemotherapy within 3 years prior to study

13. Treatment with systemic corticosteroids within 3 months prior to study

14. Known or suspected allergy to dulaglutide

15. Claustrophobia or other contraindications for magnetic resonance imaging

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

Weight & body composition
2
Safety / tolerability / PK
2
Other clinical outcomes
2
Other (unclassified)
2

Weight & body composition

2 endpoints
Primary/registry result

Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).

Time frame:16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), fat/muscle ratio95% CI
Dulagutide Arm-0.009
Primary/protocol endpoint

Changes in Intermuscular Fat Deposition as Assessed by Magnetic Resonance Imaging (MRI).

Time frame:16 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/registry result

Safety and Feasibility of Dulaglutide Treatment as Evaluated by Subject Interview, Continuous Glucose Monitoring, Adverse Events (AE), Laboratory Tests, Vital Signs, ECG & Allergic/Hypersensitivity Reactions.

Time frame:16 weeks

Treatment-emergent AEs (any)

descriptive

Posted result

GroupValue (count_of_participants), Participants95% CI
Dulagutide Arm2
Primary/protocol endpoint

Safety and Feasibility of Dulaglutide Treatment as Evaluated by Subject Interview, Continuous Glucose Monitoring, Adverse Events (AE), Laboratory Tests, Vital Signs, ECG & Allergic/Hypersensitivity Reactions.

Time frame:16 weeks

Treatment-emergent AEs (any)

descriptive

Other clinical outcomes

2 endpoints
Primary/registry result

Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test

Time frame:16 weeks

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
Dulagutide Arm0
Primary/protocol endpoint

Changes in Physical Performance as Assessed by Systemic Physical Performance Battery Test

Time frame:16 weeks

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/registry result/low confidence

Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS).

Time frame:16 weeks

change from baseline, descriptive

Primary/protocol endpoint/low confidence

Changes in Skeletal Muscle Mitochondrial Function as Assessed by Phosphocreatine Recovery Time Constant by 31P Magnetic Resonance Spectroscopy (31P-MRS).

Time frame:16 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.