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High Dose GSK4532990 for Non-alcoholic Fatty Liver Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
GSK Investigational Site, Miami, FLNon-alcoholic Fatty Liver DiseaseGSK4532990 - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will measure liver health improvements in people with NASH and advanced fibrosis treated with GSK4532990 compared to a placebo. It will last up to 76 weeks.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

2 Primary · 20 Secondary · Reporting Duration: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

At Week 24
Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24
At Week 52
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH
Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52
Week 24
Change from Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl transferase (GGT) (Units Per Liter)
Change from baseline in Enhanced Liver Fibrosis (ELF) Score and its individual components (HA, PIIINP, TIMP-1)
Liver
Change from baseline in Pro-peptide of type III collagen (Pro-C3 )
Liver
Week 52
Bilirubin
Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury)
Change from Baseline in Vital Signs - Heart Rate (Beats per minute)
Respiratory rate
Change from Baseline in Vital Signs - Temperature (Celsius)
Day 1
Apparent clearance (CL/F) of GSK4532990
Apparent terminal phase half-life (t1/2) of GSK4532990
Apparent terminal phase volume of distribution (Vz/F) of GSK4532990
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990
Maximum observed concentration (Cmax) of GSK4532990
Time of occurrence of Cmax (tmax) of GSK4532990
Up to Week 52
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Guselkumab 100mg
2
Cotadutide
2
CSG452

Trial Design

3 Treatment Groups

High Dose GSK4532990
1 of 3
Low Dose GSK4532990
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

246 Total Participants · 3 Treatment Groups

Primary Treatment: High Dose GSK4532990 · Has Placebo Group · Phase 2

High Dose GSK4532990
Drug
Experimental Group · 1 Intervention: GSK4532990 · Intervention Types: Drug
Low Dose GSK4532990
Drug
Experimental Group · 1 Intervention: GSK4532990 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-dose (day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,661 Previous Clinical Trials
7,950,081 Total Patients Enrolled
6 Trials studying Non-alcoholic Fatty Liver Disease
451 Patients Enrolled for Non-alcoholic Fatty Liver Disease
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,568 Previous Clinical Trials
6,134,075 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
292 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Age 18 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The doctor thinks you might have metabolic syndrome and non-alcoholic fatty liver disease (NAFLD).
References

Frequently Asked Questions

Are there any adverse effects to administering Low Dose GSK4532990?

"Our risk assessment at Power has assigned GSK4532990 a safety rating of 2, as the existing clinical data confirms its relative security but falls short of demonstrating efficacy." - Anonymous Online Contributor

Unverified Answer

How many participants are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov has the details of this medical study, which was launched on January 2nd 2023, and it is actively enrolling participants. A total of 246 individuals need to be recruited from two distinct sites." - Anonymous Online Contributor

Unverified Answer

Is the age limit for participants in this experiment set beyond thirty?

"This clinical trial necessitates that participants must be between 18 and 75 years of age. There are 29 studies for those under the legal age and 316 studies involving individuals over 65." - Anonymous Online Contributor

Unverified Answer

Is this research actively recruiting participants?

"Affirmative. According to clinicaltrials.gov, the trial originally posted on January 2nd 2023 is actively seeking participants. The latest update was February 8th 2023 and 246 individuals are required between two medical facilities." - Anonymous Online Contributor

Unverified Answer

Is my eligibility to join this clinical research project in any way feasible?

"This clinical trial is looking for 246 individuals, aged between 18 and 75, who are suffering from non-alcoholic fatty liver disease. Participants must also meet the following criteria: have a BMI of 25 kg/m^2 or more (or 23 kg/m^2 if Asian), demonstrate features associated with metabolic syndrome as judged by the investigator, present an NAS score >=4 with at least 1 point each in steatosis, inflammation and ballooning; Fibrosis CRN score should be 3., agree to attend all assessments required for participation in this study including a Week 52 biopsy.." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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