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GLP-1 RA on Liver OMICS in MASLD

Effect of Glucagon-like Peptide -1 Receptor Agonist on Liver Tissue and Plasma Lipids in MASLD

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06982378
Acronym
OMICS in MASLD
Enrollment
0
Registered
2025-05-21
Start date
2026-07-01
Completion date
2026-07-09
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, NAFLD, Obesity

Brief summary

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.

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

DRUGGLP-1 receptor agonist

on and not on treatment

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Changes in lipidomics profile on use of GLP-1 RA1 yearLipidomic profile being evaluated

Secondary

MeasureTime frameDescription
Changes in associated proteomics and transcriptomics with the use of GLP-1 RA1 yearproteomic and transcriptomics profiles evaluated

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026