Table 2.
Clinical trials studying effects of bile acid receptor agonists in NAFLD.
| References | Drug, dose, frequency, and duration | Finding or objective | Phase of trial | Status |
|---|---|---|---|---|
| NCT00501592, (Mudaliar et al. [113]) | OCA; 25 mg, 50 mg, or placebo; once daily; 6 weeks | Finding: improved insulin sensitivity and reduced markers of liver inflammation and fibrosis in patients with T2DM and NAFLD | Phase 2 | Completed |
| NCT01265498 (Neuschwander-Tetri et al. [97]) | OCA, 25 mg or placebo, once daily, 72 weeks | Finding: improved liver histology in noncirrhotic NAFLD | Phase 3 | Completed |
| NCT02633956 | OCA; 5 mg, 10 mg, 25 mg, or placebo; once daily | Objective: effects of OCA and atorvastatin treatment on lipoprotein metabolism in NAFLD | Phase 2 | Completed |
| NCT02548351 | OCA; 10 mg, 25 mg, or placebo; once daily | Objective: histology and liver-related clinical outcomes in patients with noncirrhotic NAFLD with liver fibrosis | Phase 3 | Ongoing |
| NCT03439254 | OCA; 10 mg, 25 mg, or placebo; once daily | Objective: liver histology in adults with compensated cirrhosis due to NAFLD | Phase 3 | Ongoing |
| NCT01999101 | GS-9674 (Px-104), 5 mg, 28 days | Objective: analysis of clinical chemistry, hematology, and assessment of clinical signs and adverse events of Px-104 in adult NAFLD patients | Phase 2 | Terminated |
| NCT02854605. Abstract in The Liver Meeting 2018 | GS-9674; 30 mg, 100 mg, or placebo; once daily; 24 weeks | Finding: decline in hepatic fat, improvement in liver biochemistry tests, and reduction in bile acid synthesis | Phase 2 | Completed |
| NCT02781584 | GS-9674, 30 mg, once daily, 12 weeks | Objective: treatment with GS-9674, selonsertib, and GS-0976 alone or in combination, in NAFLD patients with advanced fibrosis | Phase 2 | Ongoing |
| NCT02913105 | LMB763, dose not revealed, once daily, 12 weeks | Objective: effects of LMB763 with respect to safety, tolerability, and inflammation in patients with NAFLD | Phase 2 | Ongoing |
| NCT02855164 | LJN452 or placebo, dose and frequency not revealed, 12 weeks | Objective: effects of different doses of LJN452 with respect to safety, tolerability, and on markers of liver inflammation in patients with NAFLD | Phase 2 | Ongoing |
OCA: obeticholic acid; T2DM: type 2 diabetes mellitus; NAFLD: nonalcoholic fatty liver disease.