GLP-1 RA on Liver OMICS in MASLD

NCT06982378 | Not Yet Recruiting FDA Drug

• 1 other identifier: PRO00050604
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in lipidomics profile on use of GLP-1 RA

  Lipidomic profile being evaluated

  1 year

Secondary Outcomes (1)

• Changes in associated proteomics and transcriptomics with the use of GLP-1 RA

  1 year

Study Arms (2)

Without GLP-1 RA treatment

Patients with MASLD and obesity/diabetes - on standard of care treatment but not on any GLP-1 RA

Had GLP-1 RA treatment

Patients with MASLD and obesity/diabetes - on GLP-1 RA as a standard of care treatment

Drug: GLP-1 receptor agonist

Interventions

GLP-1 receptor agonist DRUG

on and not on treatment

Had GLP-1 RA treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

known diagnosis of MASLD by histology, also have diabetes/ obesity

You may qualify if:

• known diagnosis of MASLD by histology, also have diabetes/ obesity
• on treatment with GLP-1 RA at stable dose

You may not qualify if:

• unable to have a liver biopsy, recent change in medication for diabetes or hyperlipidemia
• on immunosuppression, liver or kidney transplant
• pregnancy

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue and plasma

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Achuthan Sourianarayanane, MD

CONTACT

4149556850; asourianar@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)