GB1211 in Patients with Suspected/Confirmed NASH and Liver Fibrosis

• Research type

  Research Study

• Full title

  GULLIVER-1 - A Randomised, Double-Blind, Placebo Controlled, Phase Ib, 12-week Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants with Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

• IRAS ID

  281087

• Contact name

  Jude Oben

• Contact email

  jude.oben@gstt.nhs.uk

• Sponsor organisation

  Galecto Biotech AB

• Eudract number

  2020-000687-34

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  The purpose of the study is to find out how well the study drug GB1211 works and how safe it is compared to a placebo in participants that have confirmed or suspected Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis. GB1211 has already been studied in 58 healthy participants but this will be the first study in participants with confirmed or suspected NASH or Fibrosis.
  GB1211 is an oral drug in capsule form.
  Approximately 72 people will take part in the study in the United States, United Kingdom and France. Each participant will attend 7 site visits (9 visits for those participating in the optional PK/PD sampling) and 2 telephone study visits over 12 weeks. The first 21 patients at select sites will also participate in the intense Pharmacokinetic/Pharmacodynamic group, these patients will have additional blood testing to check how the drug affects their body and how their body affects the drug. Participants in this group will also have 2 additional site visits during the 2.5 months.
  All participants will undergo a number of tests at each visit including blood tests, physical examinations, liver scan and ECG.
  Participants in this study will be randomised to get one of the following treatments:
  Treatment 1: GB1211 10mg twice a day (2 x 5mg capsules)
  Treatment 2: GB1211 100mg twice a day (2 x 50mg capsules)
  Treatment 3: Placebo twice a day

  Taking part in the study is entirely voluntary.
  

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  20/ES/0117

• Date of REC Opinion

  17 Dec 2020

• REC opinion

  Further Information Favourable Opinion