$9.5 million Novo Nordisk grant to fund trial of Ozempic, Wegovy for fibrosis in NAFLD
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Novo Nordisk has awarded a $9.57 million grant supporting a clinical trial at the University of California San Diego NAFLD Research Center to evaluate the use of semaglutide in patients with fibrosis due to nonalcoholic fatty liver disease.
NAFLD remains the second leading indication for liver transplantation in the United States, affecting approximately 24% of adults according to the NIH. Despite multiple hopeful contenders in the race for a first-to-market therapy, none have yet crossed the FDA finish line.
However, following the recent boom in glucagon-like peptide-1 (GLP-1) receptor agonists for weight loss, drugs like Ozempic or Wegovy (semaglutide, Novo Nordisk) have demonstrated potential for reversing fatty liver disease among patients with type 2 diabetes and obesity, who are at higher risk for developing NAFLD.
“Liver disease is a silent killer, and most people do not know they have a liver problem until it is advanced to cirrhosis because there are no obvious symptoms,” Rohit Loomba, MD, chief of the division of gastroenterology and hepatology and director of the NAFLD Research Center at UC San Diego School of Medicine, said in a press release. “Being awarded this grant represents an important step toward engaging populations in research, science and medicine to improve the health of individuals currently living with NAFLD.”
The grant from Novo Nordisk will support a phase 2 clinical trial known as “semaglutide treatment in the real-world for fibrosis due to NAFLD in obesity and type 2 diabetes mellitus” (SAMARA), which will examine semaglutide as a potential treatment for NAFLD among patients at higher risk for the disease.
“The results from our study could have a global impact on clinical care for patients with NAFLD and other chronic liver diseases,” Loomba noted in the release.
The SAMARA clinical trial is projected to include 120 patients with type 2 diabetes and obesity randomized to receive either once-weekly Ozempic or a placebo, adhering to a dose escalation schedule for a period of 16 weeks until they attain a 2.4 mg weekly dose. As part of the study, patients will undergo routine bloodwork and be tested for liver stiffness and liver fat using an ultrasound-based device in their primary care doctor’s office.
“Unlike other similar trials for NAFLD, the SAMARA study is the first of its kind in that it will be screening patients for eligibility using non-invasive methods that are applicable and practical in real-world, primary care settings,” Lomba said in the release. “By doing this in the primary care doctor’s office, we are hopeful this will provide an improvement in the detection and care for patients.”
Trial patients are currently being enrolled through UC San Diego Health, with plans to open additional trial sites through federally qualified health centers operating in Vista and Riverside counties to allow for underserved populations to also join the study. Once the preliminary SAMARA study is completed, researchers plan to conduct a larger, multicenter, international trial.
Reference:
- Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM (SAMARA). https://classic.clinicaltrials.gov/ct2/show/NCT06005012?term=semaglutide&cond=NAFLD&draw=2&rank=4Accessed Aug. 29, 2023.
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Press release.
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