DelfaGLP-1 Atlas

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Not yet recruitingPhase NA

Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.

Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide - a Randomized Controlled Trial.

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

90

estimated

Study population

Chronic kidney disease, MASH / NAFLD / liver fibrosis, Type 2 diabetes

Key I/E criteria

•HbA1c ≤10%•eGFR ≥50•UACR ≥300

Primary endpoint

•Custom renal composite (eGFR, change, End-stage renal disease, Renal death, Cardiovascular death)

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 IDNCT07391267
Org study IDILBS-CKD-01

Timeline

Milestones

Study start2026-02-01estimated
Study first posted2026-02-05actual
Last update posted2026-02-05actual
Primary completion2028-12-31estimated
Study completion2028-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseMASH / NAFLD / liver fibrosisType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•1.Age above or equal to 18 years at the time of signing informed consent. 2.Diagnosed with type 2 diabetes mellitus 3.HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol) 4.Renal impairment defined either by:
•serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
•serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g 5.Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.

Exclusion criteria

1. Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)

2. Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).

3. Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.

4. Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).

5. Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.

6. Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).

7. Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.

8. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations

9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.

10. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure

11. Planned coronary, carotid or peripheral artery revascularisation

12. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis 13 Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupildilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Endpoints (24)

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

MASH / liver
8
Renal / kidney
8
Cardiometabolic biomarkers
3
Cardiovascular outcomes
2
Weight & body composition
1
Glycemic / diabetes
1
Safety / tolerability / PK
1

Cardiovascular outcomes

2 endpoints
Secondary/protocol endpoint

ime to first occurrence of a composite cardiovascular major adverse cardiovascular event (MACE) endpoint consisting of: Non-fatal myocardial infarction, non-fatal stroke, and cardiovascular (CV) death

Time frame:3 months, 6 months, 12 months,18 months and 24 months

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/protocol endpoint

Time to occurrence of all-cause death

Time frame:3 months, 6 months, 12 months,18 months and 24 months

All-cause death

time to event, event

SNOMED 419620001

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in bodyweight

Time frame:3 months, 6 months, 12 months,18 months and 24 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HBA1c

Time frame:3 months, 6 months, 12 months,18 months and 24 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

8 endpoints
Secondary/protocol endpoint

Changes in the liver histology in the animal model as assessed by Alpha-SMA, Col-1.

Time frame:4,8,16,24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in the liver histology in the animal model as assessed by SGOT/SGPT.

Time frame:4,8,16,24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

MASH resolution + fibrosis improvement

categorical status, improvement

Secondary/protocol endpoint

Changes in liver stiffness values assessed by transient elastography (FibroScan®)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

Liver stiffness (VCTE), change

change from baseline, improvement

Secondary/protocol endpoint

Change in ELF (Enhanced Liver Fibrosis) score

Time frame:3 months, 6 months, 12 months,18 months and 24 months

ELF score, change

change from baseline, improvement

Secondary/protocol endpoint

Change in ALT/AST

Time frame:3 months, 6 months, 12 months,18 months and 24 months

change from baseline, improvement

componentsALT, change, AST, change

Secondary/protocol endpoint

Change in CAP (Controlled Attenuation Parameter) values assessed by transient elastography (FibroScan)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in FAST (FibroScan-AST) score

Time frame:3 months, 6 months, 12 months,18 months and 24 months

change from baseline, improvement

Renal / kidney

8 endpoints
Primary/protocol endpoint

Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease.

Time frame:3 months, 6 months, 12 months,18 months and 24 months

Custom renal composite

time to event, event

componentseGFR, change, End-stage renal disease, Renal death, Cardiovascular death

Secondary/protocol endpoint

Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI))

Time frame:3 months, 6 months, 12 months,18 months and 24 months

eGFR slope (total)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR and proteinuria.

Time frame:3 months, 6 months, 12 months,18 months and 24 months

change from baseline, improvement

Secondary/protocol endpoint

Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

eGFR slope (chronic)

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in eGFR (CKD-EPI) and cystatin C

Time frame:3 months, 6 months, 12 months,18 months and 24 months

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Change in albumin creatinine ratio(ACR)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

Changes in the renal histology in the animal model as assessed by UPCR,GFR,Creatinine clearance.

Time frame:4,8,16,24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in the renal histology in the animal model as assessed by FITC-Sinistrin Clearance,cystatin-C.

Time frame:4,8,16,24 weeks

change from baseline, descriptive

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change in Systolic and diastolic BP

Time frame:3 months, 6 months, 12 months,18 months and 24 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in inflammation assessed by hsCRP (High Sensitive C-Reactive Protein)

Time frame:3 months, 6 months, 12 months,18 months and 24 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in triglyceride/LDL

Time frame:3 months, 6 months, 12 months,18 months and 24 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of hypoglycemic episodes

Time frame:3 months, 6 months, 12 months,18 months and 24 months

Documented hypoglycemia

event count, event

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.