Dose Exploration Study of GSK4532990 in Participants With NASH or Suspected NASH (SKYLINE)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06104319 |
Recruitment Status :
Recruiting
First Posted : October 27, 2023
Last Update Posted : March 18, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-alcoholic Fatty Liver Disease | Drug: GSK4532990 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2a, Single Dose, Open-label, Dose Exploration Study to Assess the PK-PD Activity, Safety, and Tolerability of GSK4532990 in Adult Participants With NASH or Suspected NASH |
Actual Study Start Date : | January 22, 2024 |
Estimated Primary Completion Date : | June 27, 2025 |
Estimated Study Completion Date : | June 27, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: GSK4532990 Dose 1
Participants will receive GSK4532990 Dose 1
|
Drug: GSK4532990
GSK4532990 will be administered |
Experimental: GSK4532990 Dose 2
Participants will receive GSK4532990 Dose 2
|
Drug: GSK4532990
GSK4532990 will be administered |
Experimental: GSK4532990 Dose 3
Participants will receive GSK4532990 Dose 3
|
Drug: GSK4532990
GSK4532990 will be administered |
Experimental: GSK4532990 Dose 4
Participants will receive GSK4532990 Dose 4
|
Drug: GSK4532990
GSK4532990 will be administered |
- Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels [ Time Frame: Baseline (Day 1) and up to Week 16 ]
- Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels [ Time Frame: Baseline (Day 1) and up to Week 16 ]
- Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 [ Time Frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose ]
- Maximum observed concentration (Cmax) of GSK4532990 [ Time Frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose ]
- Percent change from baseline in the observed HSD17B13 protein expression levels [ Time Frame: Baseline and Weeks 8, 12, or 16 post-dose ]
- Percent change from baseline in the observed HSD17B13 mRNA expression levels [ Time Frame: Baseline and Weeks 8, 12, or 16 post-dose ]
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant must be 18 to 75 years of age.
- Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
- Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
- Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
- Cirrhosis or current unstable liver or biliary disease.
- Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
- Known weight loss of ≥5% within 3 months prior to Screening.
- Weight reduction surgery or procedures within 2 years of Screening.
- Any contraindication to undergoing liver biopsy.
- Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06104319
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
United States, California | |
GSK Investigational Site | Recruiting |
Chula Vista, California, United States, 91911 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Victoria Mirza | |
GSK Investigational Site | Recruiting |
Chula Vista, California, United States, 91911 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Michael Patrick Waters | |
GSK Investigational Site | Recruiting |
Montclair, California, United States, 91763 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Rizwana Mohseni | |
GSK Investigational Site | Recruiting |
San Diego, California, United States, 91942 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Jeffrey Scott Overcash | |
United States, Florida | |
GSK Investigational Site | Recruiting |
Brandon, Florida, United States, 33511 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Patrick Weston | |
GSK Investigational Site | Recruiting |
Miami Lakes, Florida, United States, 33014 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Robert G. Perry | |
GSK Investigational Site | Recruiting |
Miami, Florida, United States, 33155 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Keila Hoover | |
GSK Investigational Site | Recruiting |
Miami, Florida, United States, 33173 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Barbara Moscoso | |
United States, Indiana | |
GSK Investigational Site | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Raj Vuppalanchi | |
United States, Kansas | |
GSK Investigational Site | Recruiting |
El Dorado, Kansas, United States, 67042 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Michael Rausch | |
United States, Louisiana | |
GSK Investigational Site | Recruiting |
Marrero, Louisiana, United States, 70072 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Gary Reiss | |
United States, North Carolina | |
GSK Investigational Site | Recruiting |
Morehead City, North Carolina, United States, 28557 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Kathryn Jean Lucas | |
United States, Texas | |
GSK Investigational Site | Recruiting |
Austin, Texas, United States, 78745 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Nomita Jairaj Kim | |
GSK Investigational Site | Recruiting |
San Antonio, Texas, United States, 78215 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Eric J Lawitz | |
GSK Investigational Site | Recruiting |
San Antonio, Texas, United States, 78240 | |
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Principal Investigator: Nitendra Agarwal |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT06104319 |
Other Study ID Numbers: |
218675 |
First Posted: | October 27, 2023 Key Record Dates |
Last Update Posted: | March 18, 2024 |
Last Verified: | March 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | 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. |
Access Criteria: | 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. |
URL: | https://www.gsk.com/en-gb/innovation/trials/data-transparency/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
GSK4532990 Non-alcoholic steatohepatitis (NASH) Non-alcoholic fatty liver disease (NAFLD) Suspected NASH |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |