Health Condition 1: K759- Inflammatory liver disease, unspecified
Conditions
Interventions
Intervention1: Drug: GSK4532990
: 100mg Arm
Dose: 1.5ml (0.5ml GSK4532990 + 1ml 0.9% NS)
Frequency: Every 4 weeks
Route of Administration: Subcutaneous
Total Duration: 52 weeks
200mg Arm
Dose: 1.5ml
Sponsors
GSK Research and Development Limite
GSK Research and Development Limite
Eligibility
Inclusion criteria
Inclusion criteria: BMI = 25 KG per meter square (all ethnic origins) except for Asian Participants who qualify for the study with BMI =23Kg/m2 at screening. In the opinion of the investigator there are features of metabolic syndrome and NAFLD is the most likely cause of Liver disease. Able and willing to comply with all the study assessments including a liver biopsy at week52.
Exclusion criteria
Exclusion criteria: 1) Cirrhosis (based on screening biopsy or historical biopsy showing definitive cirrhosis). 2) Current alcohol consumption =14 standard drinks (24 units, 196 g ethanol) per week for females or =21 standard drinks (37 units, 294g ethanol) per week for males. 3) Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1. 4) History of cancer within previous 2 years from Screening 1, except adequately resected non-melanoma skin cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Percentage of Participants Achieving = 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH [ Time Frame: At Week 52 ] Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation. 2) Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis [ Time Frame: At Week 52 ] NASH resolution is defined as a ballooning score of 0 and an inflammation score of 0-1. No worsening of fibrosis is defined as no increase in CRN fibrosis score.Timepoint: 52 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Pro-peptide of type III collagen. Change from baseline in liver fat using MRI-PDFF.Change from baseline in Liver stiffness measurement by VCTE.Change from baseline in Enhanced Liver Fibrosis Score and its individual components (HA, PIIINP, TIMP-1).% of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24.% of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52.Change from Baseline in ALT, AST and GGT.% of Participants with AEs and SAEs .Change from Baseline in Vital Signs - BP,Temp,HR,RR.Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine.% of Participants with Anti-drug Antibodies (ADA) to GSK4532990Timepoint: Baseline (Day 1) and up to Week 52 | — |
Countries
Argentina, Belgium, Canada, France, Greece, India, Italy, Japan, Mexico, Republic of Korea, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactSwapnali Raut
GSK Pharma India Private Limited
Outcome results
None listed