Table 3.
Effect of PPRA agonist in patients of NAFLD/NASH: Data from clinical studies.
| Drugs | Types | Treatment duration | Population | Effects | Adverse events | References | |
|---|---|---|---|---|---|---|---|
| PPRA-γ agonist | Pioglitazone (45mg/day) and additional dietary and exercise interventions | randomized, double-blind, placebo-controlled trial | 18 mouths | T2DM with NASH | improvement in liver histology, not worsened fibrosis | weight gain (in women) | Cusi et al. (71) |
| Pioglitazone(30mg/day) | randomized, controlled clinical trial | 96 weeks | NASH | improvement in liver histology, liver enzyme level and IR | weight gain | Sanyal et al. (98) | |
| Pioglitazone (30mg/day) | randomized placebo-controlled trial | 12 mouths | NASH | improvement in Liver metabolic and histological parameters | rash, fluid retention | Aithal et al. (99) | |
| Pioglitazone (45mg/day) and additional dietary and exercise interventions) | placebo-controlled trial | 6 mouths | impaired glucose tolerance or T2DM and NASH | improvement in metabolism and liver histology | Fatigue and mild lower-extremity edema | Belfort et al. (100) | |
| PPRA-α/γ agonist | Saroglitazar(1/2/4 mg/day) | randomized, double-blind, controlled phase 2 clinical trial | 24 weeks | NASH | liver histology improvement | NA | Siddiqui et al. (158) |
| Saroglitazar (1/2/4 mg/day) | randomized, double-blind, controlled phase 2 clinical trial | 16 weeks | NAFLD/NASH | liver fat content and triglyceride levels improvement | diarrhea, cough, abdominal pain, bronchitis and rash | Gawrieh et al. (160) | |
| Pan-PPRA agonist | Lanifibranor (800/1200 mg/day) | double-blind, randomized, placebo-controlled phase 2b trial | 24 weeks | NASH | fibrosis score (SAF-A) improvement | diarrhea, nausea, peripheral edema, anemia, and weight gain | Francque et al. (161) |
| PPRA-α/δ agonist | Elafibranor (80/120 mg/day) | international, randomized, double-blind placebo-controlled trial | 52 weeks | NASH | LFC and liver enzyme improvement, not worsened fibrosis | reversible increase in creatinine levels | Ratziu et al. (163) |
| PPRA-α agonist | Pemafibrate (0.2mg twice daily) | double-blind, placebo-controlled, randomised multicentre, phase 2 trial | 72 weeks | NASH | liver hardness decrease | gastrointestinal disorders, cough, rash | Nakajima et al. (164) |