According to Yahoo Finance, D&D Pharmatech has initiated dosing in their Phase 1 trial of DD01, a treatment for nonalcoholic fatty liver disease (NAFLD) and diabetes in obese patients. As NAFLD patients hold the potential to develop nonalcoholic steatohepatitis (NASH), it is essential that they stop or reverse disease progression.
Nonalcoholic fatty liver disease occurs when fat builds in the liver of someone who drinks little to no alcohol. The accumulation of fat causes pain in the upper right abdomen and fatigue, and as more builds up, symptoms progress to a swollen abdomen, jaundice, enlarged blood vessels and spleen, and red palms. Managing this condition is integral, as it can lead to complications like cardiovascular disease, liver failure, cirrhosis, and liver cancer.
Medical professionals do not know why some people develop this condition while others do not, but they have identified risk factors: obesity, type 2 diabetes, insulin resistance, high blood sugar, sleep apnea, polycystic ovary syndrome, high cholesterol, high levels of fat in the blood, being of older age, and an underactive thyroid or pituitary gland. Lifestyle changes are the best way to treat this condition, such as losing weight, eating a healthy diet, and exercising regularly. A liver transplant may be necessary if cirrhosis has occurred.
DD01 works to stimulate GLP-1R and the glucagon receptor. It is a dual antagonist treatment strategy, which differs from typical NAFLD therapies; however, this form of treatment is gaining popularity.
This disease-modifying therapy is meant to induce weight loss, heighten glucose tolerance, and reduce fat in the liver, and was proven to do so in preclinical studies. In fact, this research demonstrated that DD01 improves the metabolism of fats and lipids while fixing insulin sensitivity. Additionally, these results were sustained even after treatment was stopped.
About the Phase 1 Study
This double-blind, single and multiple ascending doses, randomized, and placebo-controlled study was designed to evaluate DD01’s pharmacodynamic effects, safety, and pharmacokinetics. 64 patients will enroll in the study, the first of which has already been dosed.
As NAFLD nor NASH have viable treatment options, the development of this drug is very important. It could fill a severe unmet medical need.