Adiponectin Biomarker Trial for Metabolic Disorders
ClinicalTrials.gov Studies
Summary
NIH registered an open-label randomized controlled trial (NCT07539584) evaluating whether high-molecular-weight adiponectin levels predict treatment response in 130 adults aged 40-65 with type 2 diabetes and metabolic dysfunction-associated fatty liver disease. Patients are randomized to SGLT2 inhibitor monotherapy, GLP-1 receptor agonist monotherapy, combination therapy, or no drug therapy. The primary outcome is change in serum HMW-adiponectin levels over 6 months; secondary outcome is change in liver steatosis measured by Controlled Attenuation Parameter.
What changed
NIH added a clinical trial registration for a randomized controlled trial studying adiponectin as a biomarker in patients with type 2 diabetes and metabolic dysfunction-associated fatty liver disease. The trial will randomize 130 participants across four arms and follow them for 6 months.
Pharmaceutical companies developing GLP-1 receptor agonists or SGLT2 inhibitors for metabolic indications should track this trial for post-hoc subgroup data on adiponectin responders. Healthcare providers managing patients with MAFLD and T2DM may gain additional biomarker insights to guide therapy selection once results are published.
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Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Adiponectin in Patients With Metabolic Disorders
N/A NCT07539584 Kind: NA Apr 20, 2026
Abstract
Background. Metabolic dysfunction-associated fatty liver disease (MAFLD/MASLD) is highly prevalent in patients with type 2 diabetes mellitus (T2DM) and is associated with insulin resistance. Adiponectin, particularly its high-molecular-weight (HMW) form, is a promising biomarker of metabolic status. However, its role in predicting response to antidiabetic therapy remains unclear.
Objective. To evaluate the association between circulating HMW-adiponectin levels and the clinical course of MAFLD in patients with T2DM receiving different treatment regimens: glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors), and their combination.
Study Design. Open-label randomized controlled trial.
Population. Adults aged 40-65 years with confirmed T2DM and MAFLD, body mass index 25-39.9 kg/m², with glycated hemoglobin exceeding the target by no more than 1%.
Interventions. Patients were randomized into three intervention groups (n=30 each): SGLT2 inhibitor monotherapy, GLP-1 RA monotherapy, or combination therapy. A control group (n=40) received no drug therapy for MAFLD.
Outcome Measures. Primary outcome: change in serum HMW-adiponectin levels from baseline to 6 months. Secondary outcome: change in liver steatosis measured by Controlled Attenuation Parameter (CAP).
Timeframe. Follow-up duration: 6 months.
Conclusion. This study will determine whether baseline HMW-adiponectin levels predict the reduction in liver steato...
Conditions: Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD), Type 2 Diabetes Mellitus (T2DM)
Interventions: SGLT2 inhibitor, GLP-1 RA
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