| Methods |
Randomised clinical trial |
| Participants |
Country: Multicentre, international.
Number randomised: 99.
Post‐randomisation drop‐outs: 3 (3%).
Revised sample size: 96.
Average age: 45 years.
Females: 26 (27.1%).
NASH: 96 (100%).
Diabetics: not stated.
Average follow‐up period in months: 3.
Inclusion criteria
1. Patients with NASH without cirrhosis.
2. Aged ≥ 18 years.
3. ALT > 1.5 times normal limit or > 60 U/L on more than 1 occasion.
Exclusion criteria
1. Uncontrolled diabetes.
2. Hepatic cirrhosis.
3. Liver disease other than NASH.
4. Excessive alcohol use (20 g/day for women and 30 g/day for men).
5. Weight change > 5% in the prior 6 months. |
| Interventions |
Participants were randomly assigned to two groups.
Group 1: ASP9832 (N = 66).
Further details: ASP9832 50 mg and 100 mg (random).
Group 2: control (N = 30).
Further details: control: placebo.
Duration of treatment: 3 months. |
| Outcomes |
Outcomes reported: 1. Adverse events. |
| Notes |
Reasons for post‐randomisation drop‐outs: discontinued treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "The randomization codes were created by an external organization". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The randomization codes were created by an external organization and had been concealed until the end of the study". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The participants were blinded to the received treatment; in addition, neither the investigator nor the pharmacist, nor the sponsor was aware of the treatment group". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The participants were blinded to the received treatment; in addition, neither the investigator nor the pharmacist, nor the sponsor was aware of the treatment group". |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Comment: there were post‐randomisation drop‐outs, which may be related to the treatment that the participants received. |
| Selective reporting (reporting bias) |
High risk |
Comment: protocol was not available; mortality was not reported. |
| For‐profit bias |
High risk |
Quote: "All clinical trials were sponsored by Astellas Pharma Europe BV". |
| Other bias |
Low risk |
Comment: no other risk of bias. |
