Non-alcoholic Fatty Liver DiseasePhase 2SKYLINENCT06104319

Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH

A Phase 2 study testing GSK4532990 in people with Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 24-36 weeks. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-alcoholic Fatty Liver Disease
What is being tested?: GSK4532990
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 14 sitesUnited States
Study dates: 22 Jan 2024to 23 Sep 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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®.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

GSK Investigational Site
Austin, Texas, 78745
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Chula Vista, California, 91911
GSK Investigational Site
El Dorado, Kansas, 67042
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Marrero, Louisiana, 70072
GSK Investigational Site
Miami, Florida, 33155
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Miami Lakes, Florida, 33014
GSK Investigational Site
Montclair, California, 91763
GSK Investigational Site
San Antonio, Texas, 78215
GSK Investigational Site
San Antonio, Texas, 78240
GSK Investigational Site
San Diego, California, 91911
GSK Investigational Site
San Diego, California, 91942

Other trials in United States

About this study

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

Conditions: Non-alcoholic Fatty Liver Disease
Being tested: GSK4532990
Keywords: GSK4532990, Non-alcoholic steatohepatitis (NASH), Non-alcoholic fatty liver disease (NAFLD), Suspected NASH
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK4532990Drug
GSK4532990 will be administered

Study groups in NCT06104319
Study group	Role	What they receive
GSK4532990 Dose 1	Experimental	Participants will receive GSK4532990 Dose 1 Receives: Drug: GSK4532990
GSK4532990 Dose 2	Experimental	Participants will receive GSK4532990 Dose 2 Receives: Drug: GSK4532990
GSK4532990 Dose 3	Experimental	Participants will receive GSK4532990 Dose 3 Receives: Drug: GSK4532990
GSK4532990 Dose 4	Experimental	Participants will receive GSK4532990 Dose 4 Receives: Drug: GSK4532990

What is being measured

The primary outcome is the main question the study is designed to answer.

Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 Protein Expression Levels
Predicted mean percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels quantify the predicted change in HSD17B13 protein expression, calculated as a percentage relative to baseline levels. The predictions are derived from a nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK-PD) target engagement model. This model utilized HSD17B13 protein concentrations obtained from pre-dose and post-dose liver biopsy samples. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), At weeks 8, 12 and 28
Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 mRNA Expression Levels
Predicted mean percent change from baseline (CFB) in liver biopsy-derived HSD17B13 mRNA expression levels, expressed as a percentage relative to pre-dose baseline quantified the alteration in HSD17B13 mRNA expression at each treatment arm and post-dose biopsy time. The prediction, along with its 95% prediction interval, was estimated using a nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK-PD) target engagement model. This model leveraged HSD17B13 mRNA concentrations obtained from pre-dose and post-dose liver biopsy samples. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), At weeks 8, 12 and 28

Secondary outcomes (4)

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Quantifiable Concentration (AUC0-t)
Blood samples were collected for the analysis of pharmacokinetic (PK) parameters.
Measured: Pre-dose (Day 1) and at post-dose 15, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours
Maximum Observed Concentration (Cmax)
Blood samples were collected for the analysis of pharmacokinetic (PK) parameters.
Measured: Pre-dose (Day 1) and at post-dose 15, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours
Percent Change From Baseline (CFB) in the Observed HSD17B13 Protein Expression Levels
Percent change from baseline in the observed HSD17B13 protein expression levels quantified the change in HSD17B13 protein expression relative to pre-treatment baseline levels, expressed as a percentage. This measure is calculated for each participant with non-missing baseline and post-dose liver biopsies. Percent change in data is summarized. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), At weeks 8, 12 and 28
Percent Change From Baseline (CFB) in the Observed HSD17B13 mRNA Expression Levels
Percent change from baseline (CFB) in the observed HSD17B13 mRNA expression levels, expressed as a percentage relative to pre-treatment baseline levels quantified the change in HSD17B13 mRNA expression. This measure is calculated for each participant with non-missing baseline and post-dose liver biopsies. Percent change in data is summarized. Baseline value was defined as the pre-dose value on Day 1.
Measured: Baseline (Day 1), At weeks 8, 12 and 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202423 Sep 2025

First posted27 Oct 2023
Study start22 Jan 2024
Primary completion23 Sep 2025
Study completion23 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06104319
Sponsor's protocol ID: 218675
Acronym: SKYLINE
Status last verified: Oct 2026
First submitted: 23 Oct 2023
Last updated: 27 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06104319
Acronym / sponsor ID: SKYLINE / 218675
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: GSK4532990, Non-alcoholic steatohepatitis (NASH), Non-alcoholic fatty liver disease (NAFLD), Suspected NASH
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 22 Jan 2024 (actual)
Primary completion: 23 Sep 2025 (actual)
Study completion: 23 Sep 2025 (actual)
First posted: 27 Oct 2023 (actual)
Results: Posted 27 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
GSK4532990 Dose 1	Experimental	Drug: GSK4532990Participants will receive GSK4532990 Dose 1
GSK4532990 Dose 2	Experimental	Drug: GSK4532990Participants will receive GSK4532990 Dose 2
GSK4532990 Dose 3	Experimental	Drug: GSK4532990Participants will receive GSK4532990 Dose 3
GSK4532990 Dose 4	Experimental	Drug: GSK4532990Participants will receive GSK4532990 Dose 4

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK4532990GSK4532990 will be administered	Drug	GSK4532990 Dose 1, GSK4532990 Dose 2, GSK4532990 Dose 3, GSK4532990 Dose 4

Primary outcome

Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 Protein Expression Levels
Time frame: Baseline (Day 1), At weeks 8, 12 and 28
Predicted mean percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels quantify the predicted change in HSD17B13 protein expression, calculated as a percentage relative to baseline levels. The predictions are derived from a nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK-PD) target engagement model. This model utilized HSD17B13 protein concentrations obtained from pre-dose and post-dose liver biopsy samples. Baseline value was defined as the pre-dose value on Day 1.
Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 mRNA Expression Levels
Time frame: Baseline (Day 1), At weeks 8, 12 and 28
Predicted mean percent change from baseline (CFB) in liver biopsy-derived HSD17B13 mRNA expression levels, expressed as a percentage relative to pre-dose baseline quantified the alteration in HSD17B13 mRNA expression at each treatment arm and post-dose biopsy time. The prediction, along with its 95% prediction interval, was estimated using a nonlinear mixed-effect pharmacokinetic-pharmacodynamic (PK-PD) target engagement model. This model leveraged HSD17B13 mRNA concentrations obtained from pre-dose and post-dose liver biopsy samples. Baseline value was defined as the pre-dose value on Day 1.

4 secondary outcomes

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Quantifiable Concentration (AUC0-t)
Time frame: Pre-dose (Day 1) and at post-dose 15, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours
Maximum Observed Concentration (Cmax)
Time frame: Pre-dose (Day 1) and at post-dose 15, 30 minutes, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours
Percent Change From Baseline (CFB) in the Observed HSD17B13 Protein Expression Levels
Time frame: Baseline (Day 1), At weeks 8, 12 and 28
Percent Change From Baseline (CFB) in the Observed HSD17B13 mRNA Expression Levels
Time frame: Baseline (Day 1), At weeks 8, 12 and 28

Results and safety

Results posted to the registry on 27 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK4532990 25 Milligram (mg)	17	17
GSK4532990 200 mg	15	15
GSK4532990 400 mg	15	14
GSK4532990 800 mg	14	14

Primary outcome: Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 Protein Expression Levels

Time frame: Baseline (Day 1), At weeks 8, 12 and 28. Mean (95% Confidence Interval). Unit: Percent Change

Measure	GSK4532990 25 Milligram (mg) n = 10	GSK4532990 200 mg n = 11	GSK4532990 400 mg n = 9	GSK4532990 800 mg n = 10
CFB to Week 8	-57.27 (-64.27 to -50.00)	-83.16 (-87.16 to -75.47)	-86.76 (-90.13 to -79.78)	-88.79 (-91.71 to -82.12)
CFB to Week 12	-49.03 (-55.55 to -42.73)	-80.21 (-83.96 to -75.64)	-84.94 (-87.93 to -81.06)	-87.64 (-90.16 to -83.98)
CFB to Week 28	-26.82 (-34.44 to -18.69)	-61.82 (-70.08 to -51.31)	-70.02 (-76.94 to -60.66)	-75.27 (-81.16 to -66.83)

Population analysed: HSD17B13 Protein Concentration population included all participants in the enrolled population with evaluable baseline biopsy protein assessment. Multiple Monte Carlo simulations of the PKPD model were performed on six participants per dose for the different timepoints. Simulations incorporated individual and residual variability and accounted for parameter uncertainty to generate the predicted mean and 95% CI

Primary outcome: Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 mRNA Expression Levels

Time frame: Baseline (Day 1), At weeks 8, 12 and 28. Mean (95% Confidence Interval). Unit: Percent Change

Measure	GSK4532990 25 Milligram (mg) n = 10	GSK4532990 200 mg n = 13	GSK4532990 400 mg n = 9	GSK4532990 800 mg n = 13
CFB to Week 8	-57.85 (-66.28 to -49.38)	-87.60 (-91.39 to -80.47)	-91.10 (-93.98 to -86.16)	-92.95 (-95.30 to -89.19)
CFB to Week 12	-49.98 (-56.74 to -43.04)	-84.50 (-88.03 to -80.01)	-89.07 (-91.74 to -85.56)	-91.54 (-93.69 to -88.62)
CFB to Week 28	-28.55 (-37.34 to -19.28)	-67.07 (-75.63 to -55.61)	-75.45 (-82.32 to -65.35)	-80.59 (-86.22 to -71.73)

Population analysed: HSD17B13 mRNA Concentration population included All participants in the enrolled population with evaluable baseline biopsy mRNA assessment. Multiple Monte Carlo simulations of the PKPD model were performed on six participants per dose for the different timepoints. Simulations incorporated individual and residual variability and accounted for parameter uncertainty to generate the predicted mean and 95% CI

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All cause mortality, Non-Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 87 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK4532990 25 Milligram (mg)	1 of 17 (5.9%)	8 of 17 (47.1%)	0 of 17
GSK4532990 200 mg	0 of 15 (0%)	5 of 15 (33.3%)	0 of 15
GSK4532990 400 mg	1 of 15 (6.7%)	5 of 15 (33.3%)	0 of 15
GSK4532990 800 mg	0 of 14 (0%)	8 of 14 (57.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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/

Related trials for Non-alcoholic Fatty Liver Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK4532990 in people with Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predicted Mean Percent Change From Baseline (CFB) in Liver Biopsy-derived HSD17B13 Protein Expression Levels (time frame: Baseline (Day 1), At weeks 8, 12 and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06104319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.