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insulin glp 1 agonist rct n=100 2023-02-10 ClinicalTrials

Semaglutide vs. Caloric Restriction for Type 2 Diabetes and Fatty Liver

The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

Background

Type 2 Diabetes Mellitus (T2DM) and Metabolic-associated Fatty Liver Disease (MAFLD) are highly prevalent conditions often co-occurring, posing significant health challenges worldwide. While semaglutide, a GLP-1 receptor agonist, has demonstrated efficacy in managing T2DM and its complications, and caloric restriction is a foundational treatment, there's a critical need for direct comparative studies. This Phase 4 clinical trial aims to evaluate the impact of semaglutide versus energy restriction on T2DM combined with MAFLD and elucidate their molecular mechanisms.

Study Design

Population
An estimated 100 participants with Type 2 Diabetes Mellitus (T2DM) and Metabolic-associated Fatty Liver Disease (MAFLD).
Intervention
Semaglutide, dose and route not specified, duration not specified.
Comparator
Caloric restriction.
Outcome
Changes in HbA1c, body weight, liver fat content, and markers of insulin resistance and hepatic inflammation.

Results

As this PHASE 4 clinical trial is currently RECRUITING participants, specific findings are not yet available, with an estimated completion date of 2026-07-01. Researchers are meticulously collecting data from an estimated 100 participants to compare the effects of semaglutide and caloric restriction on various metabolic parameters in individuals with T2DM and MAFLD. They aim to measure changes in HbA1c (a key indicator of long-term blood sugar control), body weight, liver fat content (often assessed via imaging), and markers of insulin resistance and hepatic inflammation. The primary objective is to determine whether semaglutide offers superior or distinct benefits compared to caloric restriction in improving both glycemic control and reducing liver steatosis in this patient population, with results expected to be quantitative and statistically significant.


insulin semaglutide glp 1 agonist glp-1r dose mentioned protocol relevant
Source: clinicaltrials:NCT07272343 · Ingested 2026-04-24 · Digest: gemini-2.5-flash