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The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efimosfermin (Dose 1) | Experimental | Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W). |
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| Efimosfermin (Dose 2) | Experimental | Participants will receive efimosfermin (Dose 2) Q4W. |
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| Placebo | Placebo Comparator | Participants will receive placebo Q4W. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efimosfermin | Drug | Efimosfermin will be administered as a subcutaneous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | To assess the effects of efimosfermin on safety and tolerability. | From Day 1 to 100 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentrations of efimosfermin | To assess the steady-state PK of efimosfermin. | Up to Week 21 |
| Maximum serum drug concentration (Cmax) of efimosfermin | To assess the steady-state PK of efimosfermin. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Chandler | Arizona | 85224 | United States |
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| Placebo | Drug | Placebo will be administered as a subcutaneous injection. |
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| Up to Week 21 |
| Area under the serum concentration-time curve (AUC) of efimosfermin | To assess the steady-state PK of efimosfermin. | Up to Week 21 |
| Average serum drug concentration (Cavg) of efimosfermin | To assess the steady-state PK of efimosfermin. | Up to Week 21 |
| Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin | To assess the steady-state PK of efimosfermin. | Up to Week 21 |
| GSK Investigational Site | Recruiting | Mesa | Arizona | 85381 | United States |
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| GSK Investigational Site | Recruiting | Tucson | Arizona | 85712 | United States |
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| GSK Investigational Site | Recruiting | Fresno | California | 93720 | United States |
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| GSK Investigational Site | Recruiting | Lancaster | California | 93534 | United States |
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| GSK Investigational Site | Recruiting | Pasadena | California | 91105 | United States |
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| GSK Investigational Site | Recruiting | Rialto | California | 92377 | United States |
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| GSK Investigational Site | Recruiting | Santa Maria | California | 93458 | United States |
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| GSK Investigational Site | Recruiting | Miami | Florida | 33156 | United States |
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| GSK Investigational Site | Recruiting | Viera | Florida | 32940 | United States |
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| GSK Investigational Site | Recruiting | Marietta | Georgia | 30060 | United States |
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| GSK Investigational Site | Recruiting | Baltimore | Maryland | 21202 | United States |
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| GSK Investigational Site | Recruiting | Kansas City | Missouri | 64131 | United States |
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| GSK Investigational Site | Recruiting | New York | New York | 10029 | United States |
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| GSK Investigational Site | Recruiting | Fayetteville | North Carolina | 28304 | United States |
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| GSK Investigational Site | Recruiting | Wilson | North Carolina | 27612 | United States |
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| GSK Investigational Site | Recruiting | Austin | Texas | 78745 | United States |
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| GSK Investigational Site | Recruiting | Austin | Texas | 78757 | United States |
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| GSK Investigational Site | Recruiting | Austin | Texas | 78757 | United States |
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| GSK Investigational Site | Recruiting | Dallas | Texas | 75203 | United States |
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| GSK Investigational Site | Recruiting | Georgetown | Texas | 78626 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77079 | United States |
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| GSK Investigational Site | Recruiting | Pasadena | Texas | 77505 | United States |
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| GSK Investigational Site | Recruiting | Pearland | Texas | 77584 | United States |
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| GSK Investigational Site | Recruiting | San Antonio | Texas | 78215 | United States |
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| GSK Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
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| GSK Investigational Site | Recruiting | Waco | Texas | 76710 | United States |
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| GSK Investigational Site | Recruiting | Richmond | Virginia | 23249 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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