Cost-utility analysis of glucagon-like peptide-1 receptor agonists for type 2 diabetes mellitus and metabolic dysfunction-associated steatotic liver disease in Thailand

Table 2 Studies of glucagon-like peptide-1 receptor agonists and improvement of ≥ 1 fibrosis stage without worsening of metabolic dysfunction-associated steatohepatitis in adults with diabetes mellitus

Ref.	GLP-1 RA	n	Study design	Participants’ characteristics	Outcome
Sanyal et al[17]	Semaglutide	1197 (25.1%, Asia; 25.3%, Europe; 35%, North America; 7.9%, South America; 6.8%, other)	RCT	Demographics: Mean age: 56.3 years in semaglutide group, 55.4 in placebo group. Female: 58.6% in semaglutide group, 54.1% in placebo group. T2DM: 55.4% in semaglutide group, 56.8% in placebo group. Inclusion criteria: Age: 18 years or older. Liver biopsy with histological evidence of MASH and fibrosis stage 2 or 3. Exclusion criteria: (1) Excessive alcohol consumption1; (2) HbA1c > 9.5%; (3) AST or ALT > 5 × ULN at screening; (4) Chronic liver disease other than MASLD; (5) Hepatic decompensation or a MELD score > 12 at screening; and (6) Treatment with any GLP-1 RA or medication used for MASH at an unstable dose within 90 days before screening	Reduction in liver fibrosis without worsening of steatohepatitis: 34.5% in the semaglutide group and 25.6% in the placebo group
Armstrong et al[9]	Liraglutide	52 (88%, White; 4%, Asian; 2%, African or Caribbean; 6%, other)	RCT	Demographics: Mean age: 50 years in liraglutide group, 52 years in placebo group. Female: 31% in liraglutide group, 50% in placebo group. T2DM: 35% in liraglutide group, 31% in placebo group. Inclusion criteria: (1) Age: 18-70 years; (2) BMI ≥ 25 kg/m2 at screening; and (3) Liver biopsy with histological evidence of MASH obtained within 6 months of screening. Exclusion criteria: (1) Excessive alcohol consumption1; (2) Poor glycemic control (HbA1c > 9.0%); (3) Child-Pugh B or C cirrhosis; (4) Confounding concomitant drug use2; and (5) History of pancreatitis and pancreatic or thyroid carcinoma	Improvement of Kleiner fibrosis stage: 26% in the liraglutide group and 14% in the placebo group

¹Excessive alcohol consumption: > 20 g/day for women and > 30 g/day for men.

²Confounding concomitant drug use: Insulin, incretin mimetics, thiazolidinediones, vitamin E.

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BMI: Body mass index; GLP-1 RA: Glucagon-like peptide-1 receptor agonist; HbA1c: Hemoglobin A1c; MASH: Metabolic dysfunction-associated steatohepatitis; MASLD: Metabolic dysfunction-associated steatotic liver disease; MELD: Model for end-stage liver disease; RCT: Randomized controlled trial; T2DM: Type 2 diabetes mellitus; ULN: Upper limit of normal.