Israeli biopharmaceutical firm Galmed has started enrolling patients in its Phase IIa Arrive trial, which is designed to evaluate aramachol as a treatment for HIV-associated lipodystrophy and nonalcoholic fatty liver disease (NAFLD).
Around 50 patients will be enrolled in the Arrive trial, which is being conducted at the NAFLD Research Center, University of California San Diego by professor Rohit Loomba.
Patients with HIV-associated lipodystrophy and NAFLD will be given either aramchol at 600mg or a placebo for 12 weeks.
The trial will also compare MRI-measured liver fat content and total body fat via dual energy x-rayabsorptiometry (DEXA) before and after treatment.
Loomba and his team of collaborators, including professor Sirlin at UCSD, will use advanced imaging methods to evaluate treatment response in patients.
Loomba said: “At the NAFLD Research Center, UCSD, our approach is to apply innovative clinical trial design by collaborating across disciplines to find solutions for clinical problems for patients suffering from liver diseases.
“The Arrive study is a prime example of this innovative team science approach as it brings together clinicians working on liver disease, MR imaging, body composition and HIV to help solve the understudied and under-appreciated issue of HIV-associated NAFLD and lipodystrophy.”
In the trial, the primary endpoint of successful therapy will be an improvement in hepatic steatosis as measured by MRI, while secondary endpoints will be an improvement in total body fat, metabolic profile, and liver biochemistry.
Galmed president and CEO Allen Baharaff said: “In patients with human immunodeficiency virus (HIV) infection, liver disease is among the leading causes of death.
“Nearly half of the HIV-infected patients without viral hepatitis that undergo evaluation for unexplained liver test abnormalities are found to have NAFLD.
“The prevalence of NAFLD is higher in individuals with HIV infection than in the general population. To date, there are no therapies for the treatment of HIV-associated NAFLD, like NASH, and clinical trials in this area have been few.”
NAFLD affects almost 30% of adults in Western countries.