NCT06104319 (SKYLINE) is a Phase 2 clinical trial of GSK4532990 in Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline.

Who is sponsoring NCT06104319?

NCT06104319 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT06104319?

Interventions in NCT06104319: GSK4532990.

What condition does NCT06104319 study?

NCT06104319 studies Non-alcoholic Fatty Liver Disease.

Is NCT06104319 still recruiting?

NCT06104319 is currently completed. Last updated 14 October 2025.

Last reviewed 2025-10-14 · How we verify

NCT06104319: SKYLINE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 14 October 2025

What this trial tests

Phase 2 trial testing GSK4532990 in Non-alcoholic Fatty Liver Disease in 61 participants. Completed in 23 September 2025.

Timeline

22 January 2024

Primary endpoint
23 September 2025

23 September 2025

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	22 January 2024
Primary completion	23 September 2025
Estimated completion	23 September 2025
Sites	14 locations across United States

Drugs / interventions tested

GSK4532990 — full drug profile →

Conditions studied

Non-alcoholic Fatty Liver Disease — all drugs for Non-alcoholic Fatty Liver Disease →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-alcoholic Fatty Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Hepatocyte targeting <i>via</i> the asialoglycoprotein receptor.
Ramírez-Cortés F, Ménová P. · · 2025 · cited 22× · PMID 39628900 · DOI 10.1039/d4md00652f
MetALD: Does it require a different therapeutic option?
Marek GW, Malhi H. · · 2024 · cited 21× · PMID 38820071 · DOI 10.1097/hep.0000000000000935
Precision medicine and nucleotide-based therapeutics to treat steatotic liver disease.
Caddeo A, Romeo S. · · 2025 · cited 17× · PMID 39103998 · DOI 10.3350/cmh.2024.0438

Verify or expand the search:

Other trials of GSK4532990

Trials testing the same drug.

NCT06613698 — A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Y · Phase 2 · recruiting
NCT05583344 — Phase 2b Study of GSK4532990 in Adults With NASH · Phase 2 · active not recruiting

Other recruiting trials for Non-alcoholic Fatty Liver Disease

Currently open trials in the same condition.

NCT07358546 — A Study of Efimosfermin Alfa in Adults With Hepatic Impairment · Phase 1 · recruiting
NCT07335198 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a · Phase 1 · recruiting
NCT07221188 — A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or · Phase 3 · recruiting
NCT07221227 — A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH · Phase 3 · recruiting
NCT07514377 — JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China · active not recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06104319 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 14 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06104319.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing