Phase 2b Study of GSK4532990 in Adults with NASH (Horizon)

• Research type

  Research Study

• Full title

  17-beta-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with Pre-Cirrhotic Non-Alcoholic Steatohepatitis

• IRAS ID

  1006533

• Contact name

  Eleanor Davies

• Contact email

  eleanor.k.davies@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2022-002538-14

• Clinicaltrials.gov Identifier

  NCT05583344

• Research summary

  Nonalcoholic steatohepatitis (NASH) is a condition in which fat builds up in the liver. NASH causes inflammation, damage and scarring of the liver. This study will test a new drug, GSK4532990, that is not yet approved. The drug works by reducing expression of a particular protein called HSD17B13 that may be involved in the development and worsening of NASH.
  The purpose of the study is to test whether GSK4532990 can improve NASH. It will also test if the drug is safe, well-tolerated and improves quality of life for people with NASH. It will also help to determine what dose of the drug works best.
  The study will involve about 246 adult participants with NASH who are 18-75 years of age. Approximately 6 patients will be in the UK. It will last for 76 weeks for each participant which includes a 10-week screening period, 52 weeks of treatment, and a follow-up period of 14 weeks.
  GSK4532990 is given via an injection under the skin. This study will test two different doses of the drug and compare it with an inactive drug (called a placebo). Participants will be randomly allocated to 3 different treatment groups as listed below.
  1. 100 mg GSK4532990 once every 4 weeks
  2. 200 mg GSK4532990 once every 12 weeks, or
  3. Placebo once every 4 weeks.
  Each participant will receive two injections of the study drug or placebo every 4 weeks for up to 52 weeks. The reason for receiving two injections is to ensure no one will be able to know which treatment group each participant is in.
  Tests undertaken will include, but are not limited to:
  - blood tests including genetic tests to identify markers in specific genes (DNA that is passed down from parents to children)
  - liver biopsy (taking a sample of tissue from the liver)
  - urine tests
  - ultrasound and MRI scans that take images of parts of the body
  - physical examination
  - questionnaires about quality of life

• REC name

  North East - York Research Ethics Committee

• REC reference

  22/NE/0218

• Date of REC Opinion

  30 Mar 2023

• REC opinion

  Further Information Favourable Opinion