Weight Loss Drug Clinical Trial Underway in Nashville

WKRN in Nashville broadcast this story on July 2, 2024 after interviewing Clinical Research Associates Medical Director Dr. Stephan Sharp. See the original here: Weight Loss Drug Clinical Trial Underway in Nashville, or go here to read about the studies mentioned in this story.

A local research lab is looking for participants in its clinical trial that looks into the newer versions of diabetes and weight management drugs.

Clinical Research Associates is conducting a drug study on glucagon-like peptide 1 (GLP-1) agonists, a class of medications used to treat Type 2 diabetes and weight loss.

“Everybody wants to come out with the next better drug, and then the older drugs kind of get laid by the wayside,” Sharp said. “This next generation we’re studying are expected to be more potent. They’re either combination drugs, or they’re drugs that act as if they were two or three drugs in one, and that’s pretty impressive.”

Dr. Stephan Sharp, medical director at Clinical Research Associates, said they are tracking several different outcomes, but their main focus is on seeing if GLP-1s, like Ozempic, Wegovy, Mounjaro and Zepbound, improve cardiovascular health.

“With all this experience we’ve had using these drugs in real life, we’ve seen reductions in heart attacks, strokes, heart failure admissions, slowed kidney damage from diabetes, and also improvements in fatty liver disease,” Sharp said. “We’ve got good evidence that’s associative evidence, it’s not proof of causality for the drugs that are on the market. Doing it in a clinical trial gives you that level of proof that it did, in fact, cause the event to be different compared to either a competitor or a placebo.”

Without insurance, GLP-1 medications can cost a pretty penny. For example, according to Ozempic’s manufacturer Novo Nordisk, the average monthly cost for Ozempic is $935.77.

All patients in Clinical Research Associates’ study get the medications for free and no insurance is required. They also receive complimentary diet and exercise counseling, 24/7 access to a medical professional and are compensated between $1,000 – $3,000.

Sharp said the community’s involvement in this study plays a critical role in finding how safe and effective these drugs are.

“We always want to encourage folks from all walks of life, all ethnicities, and races to consider participation,” Sharp said. “Overwhelmingly, the participants in studies for decades now had been white folks, …but we need to know about all types of people because sometimes we do find differences and how one group of folks responds to a drug compared to another, and if you don’t have the data, you’re not going to know that.”

This study is slated to last around two years, but Sharp said it could last longer since it’s outcome-based.

To determine if you’re eligible, you must fill out a form on the Clinical Research Associates’ website and then a member of their team will contact you to discuss your options.