Safety and effectiveness of GSK4532990 compared with placebo in adults with ALD

• Research type

  Research Study

• Full title

  A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults with Alcohol-related Liver Disease (ALD)

• IRAS ID

  1009945

• Contact name

• Contact email

  GSKClinicalSupportHD@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2024-511596-15

• Clinicaltrials.gov Identifier

  NCT06613698

• Research summary

  Alcohol-related Liver Disease (ALD) occurs after heavy and prolonged alcohol drinking. This study will test a new drug, GSK4532990 that is not yet approved for the treatment of ALD. The drug reduces expression of a liver protein that may play a role in ALD. Genetic studies strongly suggest that people with different forms of this protein have some protection from ALD.
  There are two parts to this study. The Safety Lead-in will test whether GSK4532990 is safe to administer to patients with ALD, and how the body handles the drug in patients with ALD.
  The Main Study will test whether GSK4532990 can improve ALD. It will also test how the body handles GSK4532990, whether it is safe, well-tolerated and improves quality of life for people with ALD. It will also help determine what dose of the drug works best.
  The study will involve 24 adults (18-70 years) in the Safety Lead-in, and a further 366 adults (18-65 years) in the Main Study. Approximately 20 participants will be from the UK. The Safety Lead-in is <12 weeks long, and the Main Study is <45 weeks long.
  GSK4532990 is given via an injection under the skin. Participants in the Safety Lead-in will receive one dose only of active drug. Participants in the Main Study will be randomly allocated to one of 4 different doses of GSK4532990 or to placebo (inactive drug) and will receive up to 6 doses accordingly. Neither the participant nor the study doctor will know which treatment each participant receives in the Main Study.
  Tests undertaken will include, but are not limited to:
  - blood, hair and urine tests
  - specialised ultrasound of the liver
  - physical examination
  - questionnaires
  Participants may be able to opt in to the following procedures:
  - Magnetic Resonance Elastography
  - Liver biopsy

• REC name

  Wales REC 1

• REC reference

  24/WA/0203

• Date of REC Opinion

  13 Sep 2024

• REC opinion

  Further Information Favourable Opinion