A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared with Placebo in Patients with Non-Alcoholic Steatohepatitis

Phase 1

• Conditions: on-alcoholic steatohepatitis (NASH); MedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-001897-27-FR
• Lead Sponsor: Genentech Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-07
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

- Age >= 18 and <= 75 years
- Hepatic steatosis on MRI (>= 8% average liver PDFF) prior to randomization
- Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
- Use of highly effective contraception as defined by the protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

- Patients with Type 1 diabetes, or on treatment with glucagon-like peptide-1 receptor agonists and/or thiazolidinediones
- Treatment with drugs historically associated with NAFLD for more than 2 weeks within the year prior to randomization
- History of endocrine diseases defined in the protocol including but not limited to Cushing’s disease, Addison’s disease, and hyper- or hypo-thyroidism
- History of any liver disease other than NASH, except for resolved, self-limited illnesses such as hepatitis A or E, and previous Hepatitis C and liver transplantation
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2
- Evidence of functional hepatic impairment, other forms of chronic liver disease, and cholelithiasis on ultrasound at screening - Liver enzymes levels >= 5 × upper limit of normal (ULN), Alkaline phosphatase >= 2 × ULN and total bilirubin > ULN at screening
- Actively involved in a structured weight loss, dietary program, treatment with medications for the purpose of weight loss, or planned medical procedure or surgery during the study
- Weight gain or loss > 5% within 3 months prior to randomization
- Patients with osteoporosis, other bone diseases/conditions, or have a history or are current on bone active treatments prohibited by the protocol
- Current or history of significant alcohol consumption
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified