Clinical Trials Conducted

The SOCRATES HCC Study - A randomised controlled trial of Standard Of Care versus RadioAblaTion in Early Stage HepatoCellular Carcinoma

The SOCRATES HCC study is testing whether a precise type of radiation therapy called SABR (Stereotactic Ablative Body Radiotherapy) works better than current standard treatments for people with early-stage liver cancer. These standard treatments may involve heating the tumour or injecting chemotherapy or radioactive particles into its blood supply. People aged 18 and over with a single, small liver tumour (5 cm or less) who haven’t had treatment before may be eligible. Participants are randomly placed into two groups: one will get SABR in a few short outpatient visits, and the other will receive standard treatments based on their cancer’s size and location. All participants will be followed up regularly for several years with scans, blood tests, and health checks.

DEFINERx050 - A Multicentre, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab (Anti-VEGF Antibody) as Neo-Adjuvant Therapy Versus Active Surveillance in Hepatocellular Carcinoma Patients with high Onco-Fetal Characteristics Before Surgical Resection

This study is testing whether giving two immunotherapy drugs, atezolizumab (Tecentriq) and bevacizumab (Avastin), before liver surgery can help people with liver cancer do better than surgery alone.

You can join if you’re 18 or older, have just been diagnosed with liver cancer, and your doctor recommends surgery to remove the tumour.

Participants will be randomly placed into two groups: one will get the immunotherapy first, then surgery, and the other will have surgery right away. Both groups will have regular check-ups with scans and blood tests every 3 months for 3 years.

The goal is to see if this treatment approach can lower the chance of the cancer coming back.

DEFINERx150 - Circulating biomarkers of response in advanced Hepatocellular Carcinoma

This study is about improving treatment for advanced liver cancer (hepatocellular cancer or HCC). Right now, a type of treatment called immunotherapy works for only 20-40% of patients. Researchers have found a special environment in the tumor that might help predict who will respond well to immunotherapy. The study will collect tissue and blood samples from patients to look for specific markers that can predict treatment success. Patients with advanced liver cancer who are starting immunotherapy will be followed for two years to see how well the treatment works. The goal is to find better ways to decide who will benefit most from immunotherapy and improve outcomes for future patients.

LIVERAGE 1404-0044 - A randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with noncirrhotic non-alcoholic steatohepatitis/metabolic associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis

This study is for adults with a liver condition called MASH (formerly known as NASH) and moderate to advanced liver scarring (fibrosis). It aims to find out if a new medication called survodutide can improve liver health. Participants will be randomly assigned to receive either survodutide or a placebo (a dummy treatment) once a week as an injection under the skin. Everyone in the study also gets support to eat healthier and exercise more. The study runs for up to 7 years, with regular health checks, scans, blood tests, and some liver biopsies. The goal is to see if survodutide is safe and helps improve liver function better than no treatment.

AKERO 105 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

This study is testing a new medicine called efruxifermin (EFX) to see if it helps people with non-cirrhotic NASH or MASH (types of liver disease caused by fat build-up and inflammation) who also have moderate to advanced liver scarring (fibrosis stage 2 or 3). It will involve about 1,650 participants at multiple study sites. Participants will be randomly placed into two groups — one will receive the study drug and the other a placebo (a dummy drug with no active ingredient). The study is double-blinded, meaning neither the participants nor the doctors will know who is receiving which treatment. The goal is to find out if EFX is safe and effective at treating liver disease before it becomes cirrhosis (severe scarring).

AKERO 106 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrohosis Due to NASH/MASH

This study is testing a new medication called efruxifermin (EFX) in people who have early-stage (compensated) liver scarring caused by NASH or MASH, two types of fatty liver disease. Participants will be randomly assigned to receive either EFX or a placebo (a look-alike with no active medicine), and neither the participants nor the doctors will know who is getting which. The goal is to see if EFX is safe and can help slow or improve liver disease in people with compensated cirrhosis due to NASH/MASH.

LIVERAGE 1404-0064 - A Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated nonalcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis

This study is for adults with a liver condition called NASH or MASH and a BMI of at least 27 (or 25 if Asian). It will test whether a new medicine called survodutide can help improve liver health. Participants will be randomly assigned to receive either survodutide or a placebo (a dummy treatment) as a weekly injection, along with regular advice on diet and exercise. The study lasts up to 4.5 years, with regular check-ups, blood tests, scans, and questionnaires to monitor liver function, weight, and overall health. The goal is to see if survodutide helps people with NASH/MASH more than the placebo.

AZURE-1 - A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 (brelovitug) vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

This trial is testing a new drug, Brelovitug (BJT-778), for people with chronic hepatitis delta, a serious liver infection. Participants will receive either weekly or monthly injections, or delayed treatment for 24 weeks before starting the drug. The study aims to see if Brelovitug reduces the amount of virus, improves liver health, and is safe.