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Trial record 1 of 2 for:    218675
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Dose Exploration Study of GSK4532990 in Participants With NASH or Suspected NASH (SKYLINE)

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ClinicalTrials.gov Identifier: NCT06104319
Recruitment Status : Not yet recruiting
First Posted : October 27, 2023
Last Update Posted : October 27, 2023
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24 weeks.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: GSK4532990 Phase 2

Study Design
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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 and Suspected NASH
Estimated Study Start Date : January 9, 2024
Estimated Primary Completion Date : May 26, 2025
Estimated Study Completion Date : May 26, 2025

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Predicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels [ Time Frame: Baseline (Day 1) and up to Week 16 ]
  2. Predicted percent change from baseline in liver biopsy-derived HSD17B13 mRNA expression levels [ Time Frame: Baseline (Day 1) and up to Week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Percent change from baseline in the observed HSD17B13 protein expression levels [ Time Frame: Baseline and Weeks 8, 12, or 16 post-dose ]
  4. Percent change from baseline in the observed HSD17B13 mRNA expression levels [ Time Frame: Baseline and Weeks 8, 12, or 16 post-dose ]

Eligibility Criteria
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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
Criteria

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®.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Sponsors and Collaborators
GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT06104319    
Other Study ID Numbers: 218675
First Posted: October 27, 2023    Key Record Dates
Last Update Posted: October 27, 2023
Last Verified: October 2023
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/

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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
Keywords provided by GlaxoSmithKline:
GSK4532990
Non-alcoholic steatohepatitis (NASH)
Non-alcoholic fatty liver disease (NAFLD)
Suspected NASH
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases