GS-US-454-6075: Semaglutide and Fixed-Dose Combination of Cilofexor and Firsocostat Phase 2 Study

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH)

• IRAS ID

  1006537

• Contact name

  Lisa Boyette

• Contact email

  Lisa.Boyette@Gilead.com

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2021-001445-12

• Clinicaltrials.gov Identifier

  NCT04971785

• Research summary

  Gilead Sciences, Inc. is running a Phase 2, Randomised, Double Blind, Double Dummy, Placebo Controlled Study Evaluating the Safety and Efficacy of Semaglutide (SEMA), and the Fixed Dose Combination of Cilofexor and Firsocostat (CILO/FIR), Alone and in Combination, in Subjects with Compensated Cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH).
  Currently, no treatments are approved for patients with NASH, a condition which occurs due to buildup of fat and inflammation in the liver, which over time leads to scar tissue formation called fibrosis. Patients with the most advanced level of fibrosis, cirrhosis due to NASH, are at the highest risk of complications, including liver failure and death.
  This study will test a combination treatment in patients with cirrhosis due to NASH, including a once weekly injectable (under the skin) named SEMA and a once daily oral tablet which includes two medicines (CILO/FIR).

  The goal of this study is to determine if treatment with both SEMA and CILO/FIR will lead to improvements in disease activity and fibrosis. At the end of the study, patients treated with both SEMA injectable and CILO/FIR tablet will be compared to patients treated with a placebo injectable and placebo tablet.
  Adult participants with cirrhosis (F4) due to NASH may be eligible for participation in this study. 440 participants are planned globally.

  Taking part in this study will last about 85 weeks, including 8 weeks screening, 72 weeks treatment period and 5 weeks follow-up.

  This is a randomised study with four groups:
  Group A: SEMA injection and CILO/FIR tablet
  - Group B: SEMA injection and placebo CILO/FIR tablet
  - Group C: Placebo SEMA injection and CILO/FIR tablet
  - Group D: Placebo SEMA injection and placebo CILO/FIR tablet

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  22/LO/0829

• Date of REC Opinion

  21 Apr 2023

• REC opinion

  Further Information Unfavourable Opinion