Review Article

Role of Bile Acids in Dysbiosis and Treatment of Nonalcoholic Fatty Liver Disease

Table 2

Clinical trials studying effects of bile acid receptor agonists in NAFLD.

ReferencesDrug, dose, frequency, and durationFinding or objectivePhase of trialStatus

NCT00501592, (Mudaliar et al. [113])OCA; 25 mg, 50 mg, or placebo; once daily; 6 weeksFinding: improved insulin sensitivity and reduced markers of liver inflammation and fibrosis in patients with T2DM and NAFLDPhase 2Completed
NCT01265498 (Neuschwander-Tetri et al. [97])OCA, 25 mg or placebo, once daily, 72 weeksFinding: improved liver histology in noncirrhotic NAFLDPhase 3Completed
NCT02633956OCA; 5 mg, 10 mg, 25 mg, or placebo; once dailyObjective: effects of OCA and atorvastatin treatment on lipoprotein metabolism in NAFLDPhase 2Completed
NCT02548351OCA; 10 mg, 25 mg, or placebo; once dailyObjective: histology and liver-related clinical outcomes in patients with noncirrhotic NAFLD with liver fibrosisPhase 3Ongoing
NCT03439254OCA; 10 mg, 25 mg, or placebo; once dailyObjective: liver histology in adults with compensated cirrhosis due to NAFLDPhase 3Ongoing
NCT01999101GS-9674 (Px-104), 5 mg, 28 daysObjective: analysis of clinical chemistry, hematology, and assessment of clinical signs and adverse events of Px-104 in adult NAFLD patientsPhase 2Terminated
NCT02854605. Abstract in The Liver Meeting 2018GS-9674; 30 mg, 100 mg, or placebo; once daily; 24 weeksFinding: decline in hepatic fat, improvement in liver biochemistry tests, and reduction in bile acid synthesisPhase 2Completed
NCT02781584GS-9674, 30 mg, once daily, 12 weeksObjective: treatment with GS-9674, selonsertib, and GS-0976 alone or in combination, in NAFLD patients with advanced fibrosisPhase 2Ongoing
NCT02913105LMB763, dose not revealed, once daily, 12 weeksObjective: effects of LMB763 with respect to safety, tolerability, and inflammation in patients with NAFLDPhase 2Ongoing
NCT02855164LJN452 or placebo, dose and frequency not revealed, 12 weeksObjective: effects of different doses of LJN452 with respect to safety, tolerability, and on markers of liver inflammation in patients with NAFLDPhase 2Ongoing

OCA: obeticholic acid; T2DM: type 2 diabetes mellitus; NAFLD: nonalcoholic fatty liver disease.