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news.Galmed Pharmaceuticals has randomized the first patient in the ARRIVE Study (ARamcholTM for the Reversal of HIV-AssociatEd Lipodystrophy and NAFLD), a proof-of-concept clinical trial that will evaluate the safety and efficacy of AramacholTM in up to 50 patients with HIV-associated lipodystrophy and nonalcoholic fatty liver disease, or NAFLD.
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The ARRIVE Study is a randomized, double-blinded, allocation-concealed, placebo-controlled, proof-of-concept Phase IIa clinical trial, which is an investigator-initiated study, and is being conducted at the NAFLD Research Center, University of California San Diego by Professor Rohit Loomba.
The study will evaluate up to 50 patients with HIV-Associated Lipodystrophy and NAFLD, with either AramcholTM at 600 mg or a placebo for 12 weeks. Pre- and post-treatment MRI-measured liver fat content and total body fat via dual energy x-rayabsorptiometry (DEXA) will be compared.
The primary end point of successful therapy will be an improvement in hepatic steatosis as measured by MRI. Secondary endpoints will be an improvement in total body fat, metabolic profile, and liver biochemistry.
Professor Loomba and his team of collaborators, including Professor Sirlin at UCSD, have pioneered the development of MRI-based assessment of treatment response in NAFLD, and will be using advanced imaging methods to assess treatment response in patients with HIV-associated NAFLD and lipodystrophy.
"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, and 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," said Professor Loomba, Director, NAFLD Research Center, UCSD.
"In patients with human immunodeficiency virus (HIV) infection, liver disease is among the leading causes of death," stated Galmed President and CEO, Allen Baharaff.
"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."