Patients for ARRIVE Study
Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) revealed on Tuesday that it has randomized the first patient in the Aramachol for the Reversal of Human-Immunodeficiency-Virus-Associated Lipodystrophy and Non-Alcoholic Fatty Liver Disease (NAFLD), which is more commonly known as the ARRIVE Study that shall test the efficiency and safety of Aramachol in treating about 50 people suffering from HIV-associated lipodystrophy and NAFLD.
Randomized, Placebo-Controlled, Proof-of-Concept Phase IIa Clinical Trial
The double-blinded, investigator-initiated ARRIVE study is conducted at the NAFLD Research Center of the University of California San Diego (UCSD). During the test, which is supervised by Professor Rohit Loomba, a maximum of 50 patients will be evaluated with either 600 mg of Aramchol or a placebo. They will be under observation for 12 weeks. The pre-treatment and post-treatment liver fat contant and total body fat via dual energy x-rayabsorptiometry (DEXA) will be examined. Significant indicators of the study’s success include the improvement in the MRI-measured hepatic steatosis, total body fat, liver biochemistry, and metabolic profile of the patients.
Together with Professor Sirlin and other team members at the UCSD, Professor Loomba initiated the test. In line with the NAFLD Research Center’s innovative approach of designing state-of-the-art clinical trials and working across all disciplines, they will use advanced imaging techniques to assess the overall procedure. Professor Loomba hopes that the ARRIVE Study will help in unveiling new discoveries about HIV-associated lipodystrophy and NAFLD.
Galmed CEO and President Allen Baharaff said that liver disease is one of the main causes of death among HIV patients. Moreover, persons with HIV have higher chances of acquiring NAFLD than those who are uninfected with the virus.
HIV-Associated Lipodystrophy and NAFLD by the Figures
35.30 million people are infected with HIV around the world, nearly three million of whom are residing in the US and Europe. NAFLD, on the other hand, is the leading cause of chronic liver disease, affecting approximately 30% of adults in the Western region. It represents a wide range of illnesses such as steatosis and Non-Alcoholic Steatohepatitis (NASH). In a recent clinical trial spearheaded by Professor Loomba, HIV-associated NFLD patients had higher rates of definite steatohepatitis. Both HIV and NAFLD patients are rapidly increasing worldwide with no enough treatment and medication available.