Clinical Trial: Semaglutide Versus Placebo in NIT ‐Assessed MASH —A Multicenter Randomised Placebo‐Controlled Trial (SAMARA)

Jan 13, 2026Alimentary pharmacology & therapeutics

Semaglutide Compared to Placebo in a Clinical Trial for MASH-A Assessed by NIT

AI simplified

GLP-1 Therapies on OpenScience ↗PubMed ↗DOI ↗

Abstract

Fifty-five participants were randomized in a study showing that semaglutide significantly reduced the FAST score compared to placebo.

Patients receiving semaglutide experienced a greater reduction in the FAST score (-0.28) compared to those on placebo (-0.12; p = 0.002).
A higher percentage of participants on semaglutide achieved at least 5% weight loss (64%) compared to those on placebo (8.3%; p < 0.001).
Semaglutide recipients had a 30% reduction in MRI-PDFF (60%) versus 17% in the placebo group (p = 0.047).
Significant reductions were observed in ALT, AST, GGT, HbA1c, and LDL cholesterol levels in the semaglutide group (p < 0.05).
Gastrointestinal-related adverse events were common in both groups, with no significant difference in incidence (p = 0.59).

AI simplified

BACKGROUND/AIMS: Non-invasive test (NIT)-based assessment of eligibility and treatment response with semaglutide is needed to inform clinical practice guidance. Therefore, utilising a randomised, placebo-controlled study design, we evaluated the utility of NITs to assess eligibility and treatment response in patients with suspected at-risk MASH randomised to semaglutide versus placebo.

METHODS: In this multicentre, randomised, double-blind placebo-controlled 52-week trial, patients meeting AASLD criteria for MASLD with BMI ≥ 27 kg/m, or BMI ≥ 25 kg/mand prediabetes or type 2 diabetes with liver stiffness by VCTE ≥ 8 kPa and a FAST score ≥ 0.5 were randomised to either semaglutide 2.4 mg subcutaneously weekly or placebo. The primary outcome was change in the FAST score at end of treatment from baseline. Other endpoints included changes in body weight, MRI-PDFF, ALT and HbA1c. 2 2

RESULTS: Fifty-five participants were randomised (55% women, 20% with diabetes). Mean (SD) age, BMI, and FAST at baseline were 48.8 (14) years, 40.2 (15) kg/m, 0.62 (0.12), respectively. The semaglutide group had a significantly greater reduction in FAST compared with placebo (-0.28 vs. -0.12; p = 0.002). More semaglutide recipients achieved ≥ 5% weight loss (64% vs. 8.3%; p < 0.001) and ≥ 30% reduction in MRI-PDFF (60% vs. 17%; p = 0.047). Semaglutide led to a significantly greater reduction in ALT, AST, GGT, HbA1c and LDL cholesterol (p < 0.05). Gastrointestinal-related adverse events were common but not significantly different between the two groups (p = 0.59). 2

CONCLUSIONS: A NIT-based approach to identify at-risk MASH patients for semaglutide treatment is feasible and effective. This study provides RCT data showing that FAST, ALT, AST and MRI-PDFF can be used to monitor treatment response.

Full Text

Full text is available at the source.

View full text (PDF) ↗View full text (XML) ↗View full text ↗

Clinical Trial: Semaglutide Versus Placebo in NIT ‐Assessed MASH —A Multicenter Randomised Placebo‐Controlled Trial (SAMARA)

Abstract

Full Text

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief

Abstract

Full Text

Related papers

You found one interesting study. We’ll send the next 7.

what lands in your inbox each week:

Recent issues from the glp-1 therapies brief