DRUG
GLP-1 receptor agonist
on and not on treatment
GLP-1 RA on Liver OMICS in MASLD
Status
Withdrawn
Phase
Not applicable
Enrollment
0
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
In patients with type II diabetes mellitus (T2DM) and obesity, an excess plasma-free fatty acid is found with an associated increased lipid accumulation in adipocytes and liver tissue. Lipid droplet accumulation in the hepatocytes is an initial step in the development of metabolic dysfunction associated steatotic liver disease (MASLD. Insulin resistance, which is associated with T2DM, mediates the inflammation of these lipids, resulting in the progression of MASLD to metabolic dysfunction associated steatotic hepatitis (MASH). Hence, in T2DM, obesity, and MASLD, changes in the lipid profile occur, and they are interrelated. In this study, we aim to assess improvement in the lipidomic, its associated metabolic changes and evaluate the co-regulated genes in the liver tissue among patients with MASLD with intervention with GLP-1 RA, which has shown to benefit T2DM and obesity.
Full detailed description
The study involves patients with a diagnosis of MASLD by histology and have diabetes/obesity. The 'omics' ( lipidomics, proteomics, metabolites, and inflammatory profiles and transcriptomics) data of liver tissue and plasma of patients will be compared between patients who have received 1 year of GLP-1 treatment with those who did not have GLP-1 agents. The study will evaluate the changes in different 'omics' and metabolites in the liver tissue following the use of GLP-1 agents in these patients
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 21, 2025
Study start
Jul 1, 2026
Primary completion
Jul 9, 2026
Study completion
Jul 9, 2026
Results posted
Not reported
Registry updated
Jul 13, 2026
Outcomes
What the study measures.
Primary outcomes
Changes in lipidomics profile on use of GLP-1 RA
Time frame · 1 year
Lipidomic profile being evaluated
Secondary outcomes
Changes in associated proteomics and transcriptomics with the use of GLP-1 RA
Time frame · 1 year
proteomic and transcriptomics profiles evaluated
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * known diagnosis of MASLD by histology, also have diabetes/ obesity * on treatment with GLP-1 RA at stable dose Exclusion Criteria: * unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia * on immunosuppression, liver or kidney transplant * pregnancy
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Froedtert Hospital
Milwaukee, Wisconsin, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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