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Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.
Plain-language guide to NCT07391267: not phased randomized trial of Semaglutide, fatty liver & elevated liver enzymes, 90 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07391267
- Phase
- not phased
- Status
- not yet recruiting
- Start
- 2026-02-01
- Completion (planned or actual)
- 2028-12-31
- Participants
- 90 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Chronic Kidney Diseases; MAFLD
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Semaglutide for fatty liver & elevated liver enzymes.
NAFLD and CKD frequently coexist due to shared mechanisms such as insulin resistance, inflammation, oxidative stress, dyslipidemia, and metabolic syndrome.
It had two arms (groups): Standard Medical Treatment (SMT) (active comparator) and Semaglutide with Standard Medical Treatment (experimental).
Control arm : Participants in this arm will receive Placebo with Standard Medical Treatment (SMT).
The registry classes the interventions as drug and other.
More on the Plan
Their shared risk factors, molecular mechanisms, and genetic predisposition represent the basis for this relationship.
It also promotes antioxidative and anti-inflammatory actions may be among the determining factors in this renoprotective effect, together with weight loss, blood pressure, and glucose-lowering.
Primary objective-To measure the progression of CKD and NAFLD in Semaglutide treated group versus non treated group.
Control arm-patients receiving standard of care.
Who Took Part
The registry lists 90 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: 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); congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations; myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The fatty liver & elevated liver enzymes participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
Groups ran in parallel: each of the fatty liver & elevated liver enzymes participants stayed in one arm throughout.
As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.
Those kept unaware of assignments: participant and investigator.
It started in 2026-02-01 with completion listed for 2028-12-31.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 23 secondary outcomes, for example Annual rate of change in eGFR (chronic kidney disease - epidemiology collaboration (CKD-EPI)), Change in eGFR and proteinuria, Annual rate of change in eGFR (CKD-EPI) (chronic eGFR slope), Change in eGFR (CKD-EPI) and cystatin C, Change in albumin creatinine ratio(ACR) and Change in bodyweight.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Semaglutide in 90 people with fatty liver & elevated liver enzymes.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, Fatty liver & elevated liver enzymes research.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.