Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511596-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK4532990 Dose 1 | Experimental |
| |
| GSK4532990 Dose 2 | Experimental |
| |
| GSK4532990 Dose 3 | Experimental |
| |
| GSK4532990 Dose 4 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK4532990 | Drug | GSK4532990 will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to 8 weeks | |
| Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests | Up to 8 weeks | |
| Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal) | Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device. | Baseline (Day 1) and up to Week 52 |
| Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52 | MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe. | Baseline (Day 1) and up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of GSK4532990 | Up to Day 4 | |
| Area Under the Curve from Time 0 to t [AUC (0-t)] of GSK4532990 | Up to Day 4 | |
| Area Under the Curve from Time 0 to 24 hours [AUC (0-24)] of GSK4532990 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Chandler | Arizona | 85224 | United States |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo will be administered |
|
| Up to 24 hours |
| Plasma half-life (t1/2) of GSK4532990 | Up to Day 4 |
| Apparent clearance (CL/F) of GSK4532990 | Up to Day 4 |
| Time to maximum concentration (tmax) of GSK4532990 | Up to Day 4 |
| Apparent terminal phase volume of distribution (Vz/F) of GSK4532990 | Up to Day 4 |
| Change from baseline in serum AST at Week 52 | Baseline (Day 1), and at Week 52 |
| Change from baseline in Enhanced Liver Fibrosis (ELFâ„¢) score at Week 52 | The ELFâ„¢ score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELFâ„¢ score is used as a prognostic marker for disease progression. ELFâ„¢ score will range between 4.5 to 14.7. A higher ELFâ„¢ score will predict worse prognosis | Baseline (Day 1), and at Week 52 |
| Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 | Up to Day 3 |
| Maximum observed plasma concentration (Cmax) of GSK4532990 | Up to Day 3 |
| GSK Investigational Site | Recruiting | Phoenix | Arizona | 85006 | United States |
|
| GSK Investigational Site | Recruiting | Tucson | Arizona | 85715 | United States |
|
| GSK Investigational Site | Recruiting | Davis | California | 95817 | United States |
|
| GSK Investigational Site | Recruiting | Los Angeles | California | 90033 | United States |
|
| GSK Investigational Site | Recruiting | Los Angeles | California | 90048 | United States |
|
| GSK Investigational Site | Recruiting | Brandon | Florida | 33511 | United States |
|
| GSK Investigational Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
|
| GSK Investigational Site | Recruiting | Atlanta | Georgia | 30309 | United States |
|
| GSK Investigational Site | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| GSK Investigational Site | Recruiting | Topeka | Kansas | 66606 | United States |
|
| GSK Investigational Site | Recruiting | Marrero | Louisiana | 70072 | United States |
|
| GSK Investigational Site | Recruiting | Detroit | Michigan | 48202 | United States |
|
| GSK Investigational Site | Recruiting | Las Vegas | Nevada | 89106 | United States |
|
| GSK Investigational Site | Recruiting | New York | New York | 10029 | United States |
|
| GSK Investigational Site | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
|
| GSK Investigational Site | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| GSK Investigational Site | Recruiting | Philadelphia | Pennsylvania | 19014 | United States |
|
| GSK Investigational Site | Recruiting | Arlington | Texas | 76012 | United States |
|
| GSK Investigational Site | Recruiting | Austin | Texas | 78757 | United States |
|
| GSK Investigational Site | Recruiting | Dallas | Texas | 75203 | United States |
|
| GSK Investigational Site | Recruiting | Dallas | Texas | 75235 | United States |
|
| GSK Investigational Site | Recruiting | Georgetown | Texas | 78626 | United States |
|
| GSK Investigational Site | Completed | McAllen | Texas | 78503 | United States |
| GSK Investigational Site | Recruiting | San Antonio | Texas | 78215 | United States |
|
| GSK Investigational Site | Recruiting | Richmond | Virginia | 23219 | United States |
|
| GSK Investigational Site | Recruiting | Richmond | Virginia | 23249 | United States |
|
| GSK Investigational Site | Recruiting | Buenos Aires | 1425 | Argentina |
|
| GSK Investigational Site | Recruiting | Buenos Aires | C1061AAS | Argentina |
|
| GSK Investigational Site | Recruiting | Buenos Aires | C1181ACH | Argentina |
|
| GSK Investigational Site | Recruiting | Buenos Aires | Argentina |
|
| GSK Investigational Site | Recruiting | Ciudad AutOnoma de Buenos Aire | 1118 | Argentina |
|
| GSK Investigational Site | Recruiting | Ciudad Autonoma de Buenos Aire | 1426 | Argentina |
|
| GSK Investigational Site | Recruiting | Rosario | S2002 | Argentina |
|
| GSK Investigational Site | Recruiting | San Miguel de Tucumán | T4000IHE | Argentina |
|
| GSK Investigational Site | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| GSK Investigational Site | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| GSK Investigational Site | Recruiting | Parkville Melbourne | Victoria | 3050 | Australia |
|
| GSK Investigational Site | Recruiting | Murdoch | Western Australia | 6150 | Australia |
|
| GSK Investigational Site | Recruiting | Perth | Western Australia | 6000 | Australia |
|
| GSK Investigational Site | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
|
| GSK Investigational Site | Recruiting | New Westminster | British Columbia | V3L 3W4 | Canada |
|
| GSK Investigational Site | Recruiting | Vancouver | British Columbia | V6Z 2K5 | Canada |
|
| GSK Investigational Site | Recruiting | London | Ontario | N6A 5A5 | Canada |
|
| GSK Investigational Site | Recruiting | Toronto | Ontario | M1S 4T7 | Canada |
|
| GSK Investigational Site | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
|
| GSK Investigational Site | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
|
| GSK Investigational Site | Recruiting | Terrebonne | Quebec | J6X 4P7 | Canada |
|
| GSK Investigational Site | Recruiting | Esbjerg | 6700 | Denmark |
|
| GSK Investigational Site | Recruiting | Hvidovre | 2650 | Denmark |
|
| GSK Investigational Site | Recruiting | Odense C | 5000 | Denmark |
|
| GSK Investigational Site | Recruiting | Angers | 49933 | France |
|
| GSK Investigational Site | Recruiting | Bobigny | 93000 | France |
|
| GSK Investigational Site | Recruiting | Créteil | 94000 | France |
|
| GSK Investigational Site | Recruiting | Lille | 59037 | France |
|
| GSK Investigational Site | Recruiting | Montpellier | 34295 | France |
|
| GSK Investigational Site | Recruiting | Rouen | 76031 | France |
|
| GSK Investigational Site | Recruiting | Bochum | North Rhine-Westphalia | 44892 | Germany |
|
| GSK Investigational Site | Recruiting | Berlin | 10787 | Germany |
|
| GSK Investigational Site | Recruiting | Berlin | 13353 | Germany |
|
| GSK Investigational Site | Recruiting | Kiel | 24105 | Germany |
|
| GSK Investigational Site | Recruiting | Leipzig | 04103 | Germany |
|
| GSK Investigational Site | Recruiting | Mainz | 55101 | Germany |
|
| GSK Investigational Site | Recruiting | Athens | 10676 | Greece |
|
| GSK Investigational Site | Recruiting | Athens | 11527 | Greece |
|
| GSK Investigational Site | Recruiting | Athens | 11527 | Greece |
|
| GSK Investigational Site | Recruiting | Bergamo | 24127 | Italy |
|
| GSK Investigational Site | Recruiting | Bologna | 40138 | Italy |
|
| GSK Investigational Site | Recruiting | Messina | 98124 | Italy |
|
| GSK Investigational Site | Recruiting | Milan | 20122 | Italy |
|
| GSK Investigational Site | Recruiting | Milan | 20142 | Italy |
|
| GSK Investigational Site | Recruiting | Milan | 20162 | Italy |
|
| GSK Investigational Site | Recruiting | Padova | 35131 | Italy |
|
| GSK Investigational Site | Recruiting | Roma | 00128 | Italy |
|
| GSK Investigational Site | Recruiting | Roma | 00168 | Italy |
|
| GSK Investigational Site | Recruiting | Chiba | 286-8520 | Japan |
|
| GSK Investigational Site | Recruiting | Ehime | 790-0024 | Japan |
|
| GSK Investigational Site | Recruiting | Gunma | 371-8511 | Japan |
|
| GSK Investigational Site | Recruiting | Hokkaido | 060-0033 | Japan |
|
| GSK Investigational Site | Withdrawn | Kagawa | 760-0017 | Japan |
| GSK Investigational Site | Recruiting | Kagawa | 761-0793 | Japan |
|
| GSK Investigational Site | Recruiting | Nara | 634-8522 | Japan |
|
| GSK Investigational Site | Recruiting | Niigata | 951-8520 | Japan |
|
| GSK Investigational Site | Recruiting | Osaka | 545-8586 | Japan |
|
| GSK Investigational Site | Recruiting | Osaka | 564-0013 | Japan |
|
| GSK Investigational Site | Recruiting | Osaka | 565-0871 | Japan |
|
| GSK Investigational Site | Recruiting | Saitama | 350-0495 | Japan |
|
| GSK Investigational Site | Recruiting | Shizuoka | 431-3192 | Japan |
|
| GSK Investigational Site | Recruiting | Tokyo | 180-8610 | Japan |
|
| GSK Investigational Site | Recruiting | DF | 14080 | Mexico |
|
| GSK Investigational Site | Recruiting | Mexico City | 11510 | Mexico |
|
| GSK Investigational Site | Recruiting | Monterrey | 66260 | Mexico |
|
| GSK Investigational Site | Recruiting | Katowice | 40-600 | Poland |
|
| GSK Investigational Site | Recruiting | Mysłowice | 41-400 | Poland |
|
| GSK Investigational Site | Recruiting | Warsaw | 00-124 | Poland |
|
| GSK Investigational Site | Recruiting | Johannesburg | 2193 | South Africa |
|
| GSK Investigational Site | Recruiting | Ansan | 15355 | South Korea |
|
| GSK Investigational Site | Recruiting | Bucheon-si | South Korea |
|
| GSK Investigational Site | Recruiting | Daegu | 700-721 | South Korea |
|
| GSK Investigational Site | Recruiting | Seoul | 02447 | South Korea |
|
| GSK Investigational Site | Recruiting | Seoul | 06351 | South Korea |
|
| GSK Investigational Site | Recruiting | Seoul | 07061 | South Korea |
|
| GSK Investigational Site | Recruiting | Seoul | 138-736 | South Korea |
|
| GSK Investigational Site | Recruiting | Suwon Gyeonggi-do | 442-723 | South Korea |
|
| GSK Investigational Site | Recruiting | Barcelona | 08003 | Spain |
|
| GSK Investigational Site | Recruiting | Barcelona | 08035 | Spain |
|
| GSK Investigational Site | Recruiting | Barcelona | 08036 | Spain |
|
| GSK Investigational Site | Recruiting | León | 24071 | Spain |
|
| GSK Investigational Site | Recruiting | Madrid | 28006 | Spain |
|
| GSK Investigational Site | Recruiting | Madrid | 28007 | Spain |
|
| GSK Investigational Site | Recruiting | Madrid | 28041 | Spain |
|
| GSK Investigational Site | Recruiting | Santander | 39011 | Spain |
|
| GSK Investigational Site | Recruiting | Seville | 41013 | Spain |
|
| GSK Investigational Site | Recruiting | Valencia | 46014 | Spain |
|
| GSK Investigational Site | Recruiting | Valladolid | 47003 | Spain |
|
| GSK Investigational Site | Recruiting | Vigo | 36071 | Spain |
|
| GSK Investigational Site | Recruiting | Stockholm | SE-141 86 | Sweden |
|
| GSK Investigational Site | Recruiting | Uppsala | 751 85 | Sweden |
|
| GSK Investigational Site | Recruiting | Kocaeli | İzmit | 41001 | Turkey (Türkiye) |
|
| GSK Investigational Site | Recruiting | Diyarbakır | Sur | 21280 | Turkey (Türkiye) |
|
| GSK Investigational Site | Recruiting | Adana | Yüreğir | 01230 | Turkey (Türkiye) |
|
| GSK Investigational Site | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
|
| GSK Investigational Site | Recruiting | Bristol | BS10 5NB | United Kingdom |
|
| GSK Investigational Site | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
|
| GSK Investigational Site | Recruiting | Glasgow Strathclyde | G51 4TF | United Kingdom |
|
| GSK Investigational Site | Recruiting | Leeds West Yorkshire | LS9 7TF | United Kingdom |
|
| GSK Investigational Site | Recruiting | Liverpool | L9 7AL | United Kingdom |
|
| GSK Investigational Site | Recruiting | London | NW3 2QG | United Kingdom |
|
| GSK Investigational Site | Recruiting | London | W2 1NY | United Kingdom |
|
| GSK Investigational Site | Recruiting | Middlesbrough | TS4 3BW | United Kingdom |
|
| GSK Investigational Site | Recruiting | Plymouth | PL6 5FP | United Kingdom |
|
| ID | Term |
|---|---|
| D008108 | Liver Diseases, Alcoholic |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided