Efruxifermin in patients with metabolic dysfunction-associated steatohepatitis: A GRADE-assessed systematic review and meta-analysis

Table 1 Baseline characteristics of included studies, mean ± SD/n (%)

Baseline characteristics	Harrison et al[20]		Harrison et al[22]		Noureddin et al[21]		Harrison et al[19]		Harrison et al[23]
	Efruxifermin	Placebo	Efruxifermin	Placebo	Efruxifermin	Placebo	Efruxifermin	Placebo	Efruxifermin	Placebo
Study type	RCT phase 2a		RCT phase 2b		RCT phase 2b		RCT phase 2a		RCT phase 2b
Country	United States		United States		United States, Puerto Rico, Mexico		United States		United States
Demographics
Sample size	20	10	21	10	120	61	59	21	85	43
Age (years)	61.1 ± 10.0	57.1 ± 14.4	59	55	60.5 ± 8.6	61 ± 7.5	52.0 ± 13.3	52.4 ± 9.6	52.0 ± 13	52.4 ± 9.6
Male	4 (20.0)	7 (70.0)	12 (57)	1 (10)	37 (31)	23 (38)	28 (47)	6 (29)	33 (38)	16 (37)
Female	16 (80.0)	3 (30.0)	9 (43)	9 (90)	83 (69)	38 (62)	31 (53)	15 (71)	52 (62)	27 (63)
Clinical parameters
Weight (kg)	97.9 ± 19.8	119.1 ± 30.5	101	96	NR	NR	104.9 ± 23.6	99.6 ± 15.3	103.3 ± 21.8	107.6 ± 25.6
BMI (kg/m2)	36.0 ± 5.6	39.1 ± 8.2	35	35.4	35.3 ± 6.5	36.7 ± 6.8	37.5 ± 7.3	37.6 ± 4.8	37.7 ± 6.7	38.7 ± 7.7
Type 2 diabetes	10 (50)	5 (50)	21 (100)	10 (100)	95 (79)	50 (82)	27 (46)	14 (67)	62 (73)	28 (65)
Liver profile
ALT (U/L)	31.7 ± 16.8	32.7 ± 20.0	35	31	39.2 ± 21.6	40.3 ± 22.3	57.4 ± 33.3	50.7 ± 25.2	56.6 ± 30.0	62.2 ± 41.7
AST (U/L)	31.4 ± 13.7	28.9 ± 21.1	26	24	37.3 ± 18.7	35.5 ± 17.0	40.4 ± 21.7	38.6 ± 17.8	47.2 ± 25.3	57.0 ± 45.0
Pro-C3 (μg/L)	25.6 ± 27.5	22.6 ± 11.8	86	82	144.4 ± 71.8	131.7 ± 61.9	17.5 ± 7.6	16.1 ± 6.7	16.9 ± 7.0	16.5 ± 6.1
ELF score	10.4 ± 1.2	9.7 ± 0.8	9.2	9.6	10.5 ± 0.8	10.4 ± 0.8	9.5 ± 0.8	9.5 ± 1.0	9.75 ± 0.80	9.8 ± 0.7
Liver stiffness (kPa)	22.1 ± 10.8	25.8 ± 13.2	10	12	24.3 ± 12.8	24.7 ± 14.2	NR	NR	14.9 ± 6.3	14.5 ± 6.2
Metabolic parameters
HbA1c (%)	6.1 ± 1.0	6.6 ± 1.4	7	6.5	6.7 ± 1.1	6.8 ± 1.2	6.3 ± 1.1	6.49 ± 1.0	6.75 ± 1.10	6.8 ± 1.1
Triglycerides (mg/dL)	134.6 ± 62.8	121.7 ± 59.6	163	171	154.0 ± 74.3	143.3 ± 60.1	177.6 ± 85.8	208.3 ± 132.5	156.2 ± 59.6	169.7 ± 87.3
HDL-C (mg/dL)	50.4 ± 13.8	43.3 ± 12.4	42	50	NR	NR	41.3 ± 10.5	45.1 ± 9.6	41.1 ± 8.3	42.2 ± 9.7
LDL-C (mg/dL)	90.1 ± 34.4	89.5 ± 34.7	73	98	NR	NR	106.1 ± 35.6	116.0 ± 36.5	103.5 ± 33.3	94.2 ± 33.8
Non-HDL-C (mg/dL)	119.8 ± 12.4	119.8 ± 12.4	105	131	NR	NR	141.0 ± 38.7	159.3 ± 53.3	NR	NR
HOMA-IR	8.4 ± 3.7	12.5 ± 1.1	9.7	9.2	NR	NR	14.9 ± 19.3	10.5 ± 8.2	NR	NR

RCT: Randomized controlled trial; BMI: Body mass index; ALT: Aspartate aminotransferase; AST: Alanine aminotransferase; Pro-C3: Procollagen type III N-terminal peptide; ELF: Enhanced liver fibrosis; HbA1c: Glycated hemoglobin A1c; HDL-C: High-density lipoprotein cholesterol; LDL-C: Low-density lipoprotein cholesterol; HOMA-IR: Homeostatic model assessment of insulin resistance; NR: Not reported.