Clinical Trials Revolutionize Patient’s Liver Disease

Behind Every Breakthrough

Story by:

• Annie Pierce- [email protected]

Topics covered:

• Clinical Trials
• Liver Disease
• Gastroenterology

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While Rosa Tellez-Moore sits in the waiting room in the Perlman Clinic at UC San Diego Health, she scrolls through photos of her grandkids on her phone with a sunny disposition not indicative of a patient about to discuss liver disease with her doctor.

Her name is called, and as she's guided to a clinic room where she'll meet with Irine Vodkin, MD, Tellez-Moore reflects on a very different demeanor during her first appointment with Vodkin in 2021.

A series of abnormal liver panels resulted in a referral to see Vodkin, associate professor of medicine at the University of California San Diego School of Medicine and gastroenterologist and transplant hepatologist UC San Diego Health. That was when, at age 66, a liver biopsy revealed she had metabolic dysfunction-associated steatohepatitis (MASH) with Stage 3 fibrosis, an advanced form of liver disease caused by the accumulation of fat in the liver that triggers inflammation and scarring.

Ultimately, the disease can lead to cirrhosis, and in severe cases, a liver transplant may be required.

"I was in shock," recalls Tellez-Moore, a retired medical lab technician. "I knew my labs had been elevated for quite a few years, but I had no idea how bad my situation actually was."

At the time of her diagnosis with MASH, there were no Food and Drug Administration (FDA) approved treatments. Vodkin educated Tellez-Moore on her options of standard treatment - which consisted of modifications to her weight, diet and exercise - and the option to refer her to the metabolic-dysfunction associated steatotic liver disease (MASLD) Research Center at UC San Diego School of Medicine where she could consider participating in clinical trials.

After a week of thinking through her options, she chose to pursue clinical trials and make lifestyle changes. Through the center, she enrolled in the 52-week, double-blind VK2809 clinical trial, a thyroid hormone medication being tested on its potential to decrease fat accumulation and scarring in the liver once it has progressed to MASH with moderate or advanced fibrosis.

While awaiting Vodkin's arrival in her clinic room during this recent follow-up visit, she gazes at the walls, adorned with imagery of the liver, while reflecting on the anxiety she felt in her early days of diagnosis.

"I was resolved to accept my fate, I really was," Tellez-Moore said. "But the thought that my liver may only last another 10 years just shook me. I wanted to do everything I could to be around much longer than that for my family and my grandkids."

Vodkin gives a soft knock on the clinic room door and walks in, greeting Tellez-Moore with a smile. While the visit begins with a routine checkup and doctor/patient questions and answers, it quickly progresses to a joyful reflection on Tellez-Moore's incredible results, which the two huddle over Vodkin's computer to pour through - excitedly pointing to the numbers, diagrams and results displayed on the screen.

She is currently taking a novel medication, prescribed by her primary care physician Ariel Portera, DO, that is part of another clinical trial led by Loomba and team and published in the New England Journal of Medicine - Tirzepatide for Metabolic Dysfunction-Associated Steathohepatitis with Liver Fibrosis, which is showing efficacy in MASH.

A New Era in Liver Disease Treatment

The VK2809 drug Tellez-Moore received is still in clinical trials, but it works through a similar mechanism as Resmetirom, which became the first FDA-approved treatment for MASH with moderate to advanced fibrosis in March 2024. UC San Diego participated in the Phase III trial, published in the New England Journal of Medicine. Both drugs are thyroid hormone receptor beta agonists, designed to reduce liver fat and inflammation. The FDA approved Resmetirom under accelerated approval, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need."

We're at an extremely exciting inflection point in the management of liver disease, and UC San Diego Health is at the forefront of offering research and clinical trials to patients before they would have been able to have access to them clinically," Ajmera said, adding that many years of research and ingenuity from a robust multi-disciplinary team have made UC San Diego Health a leader in the field of liver disease research.

"With approximately one third of adults having MASLD and a quarter of those having MASH, we've been committed to finding answers for unmet needs and to provide patients with substantial benefit. We're now seeing drugs that not only halt progression but may even reverse fibrosis."

Tellez-Moore's outcome is a testament to the innovation of the dedicated physicians and researchers with a calling to fight liver disease at the MASLD Research Center. With more studies and clinical trials on the horizon, hope is bright for MASLD research, which relies on patients like Tellez-Moore to contribute to data that will help future patients.

"We always thank the patients who choose to enroll in clinical trials because there's not just a potential benefit to themselves, there's also a benefit to society as it helps move the field forward. We wouldn't have gotten here if it weren't for the many thousands of patients in earlier trials that helped get us to this point," Ajmera said.

That sentiment resonates with Tellez-Moore, who realizes that the clinical trials she's participated in extend far beyond her own benefit.

Sipping her latte in the atrium at ACTRI, she reflects on the many mornings during the year-long clinical trial where she sat in this very spot, contemplating her future. An advocate for clinical trials, she recently enrolled in an Alzheimer's-specific clinical trial, motivated by her mother's battle with the disease.

"All my life I've worked in health care, wanting to help to see what the outcomes will be, not just for me, but for research - for my grandkids - for humanity."