Clinical trials for new weight loss drugs, devices, among the benefits at Weight Management Center

March 05, 2021
photo of a young woman standing before a turquoise blue wall in shade
Linda Wozniak is feeling healthier after losing 55 pounds during a clinical trial at the MUSC Health Weight Management Center. Photo provided

Weight loss is simple math, right? Eat fewer calories than you burn, and the pounds just melt away. That's how it works on paper, anyway. In real life, most everyone who’s tried to lose weight knows it isn’t always so easy.

“When you break it down to ‘consume less calories than you burn,’ obviously everyone gets that concept. But when you try to apply that to your day-to-day life – that doesn’t always work out so well,” said Linda Wozniak, who recently lost 55 pounds while participating in a clinical trial at the MUSC Health Weight Management Center.

Patrick O’Neil, Ph.D., professor in the Department of Psychiatry and Behavioral Sciences and the center’s director, said that’s why the center offers such a variety of programs, including online programs that can reach South Carolinians in every corner of the state.

“Obesity is a very complex condition with a variety of factors that can contribute to it. Management of it needs to be multifaceted as well. It’s easy to say, ‘Just push away from the table,’ but pushing away from the table is harder for some people than for others,” he said.

The center, in addition to offering more traditional weight-loss programs that utilize the expertise of on-staff dietitians, exercise physiologists, a physician, behavioral specialists and a nurse practitioner, also participates in clinical trials for new weight loss drugs and devices.

“Physicians really do not have very many options when it comes to medications that might help in the management of obesity, so there really is a need for a variety of obesity medications,” O’Neil said.

Because 42% of U.S. adults are obese, and obesity is associated with serious conditions like Type 2 diabetes, coronary heart disease and stroke, patients and their doctors need all the tools they can get to help with weight loss. But many people, in and out of the health care field, question whether it’s necessary to look for pharmacological help for obesity, arguing that diet and exercise should do the trick for everyone.

"Medication for obesity can be – for many people, not everybody – an important component of a comprehensive approach to
treating the condition."

Patrick O'Neil, Ph.D.
Director, Weight Management Center

“We don’t see a problem with medication for hypertension, in conjunction with changes in lifestyle. We don’t see a problem with diabetes medication, even though there’s a lot of lifestyle changes that are required to manage diabetes as well. Medication for obesity can be – for many people, not everybody – an important component of a comprehensive approach to treating the condition,” he said, noting that all obesity medications should be used in conjunction with those lifestyle changes.

O’Neil is particularly excited about the results of a recent phase III clinical trial that tested a weekly injection of semaglutide. Semaglutide mimics the action of the naturally occurring hormone glucagon-like peptide-1, which helps to generate the feeling of fullness while eating. Novo Nordisk currently sells the drug under the brand name Ozempic to treat Type 2 diabetes, but tested it at a higher dose, specifically for weight loss, in four slightly differing trials. MUSC Health Weight Management Center was a trial location for the study that combined the drug with intensive behavioral counseling and meal replacement options.

The study, which was recently written up in the Journal of the American Medical Association, showed that people who got the drug lost an average of 16% of their beginning body weight, compared to weight loss of 5.7% for those who received the placebo. Both groups received meal replacements during the first eight weeks and intensive behavioral therapy throughout.

Wozniak was one of the trial participants. She still doesn’t know whether she received the drug or the placebo but suspects, given how much weight she lost, that she received the medication.

She injected herself weekly from the fall of 2018 until the beginning of 2020. With the advent of COVID-19 and lockdowns, she’s gained some back but has mostly maintained the weight loss. The intensive behavioral counseling was important for her, she said, because she learned tips and tricks that she’s been able to continue after the trial ended.

While Novo Nordisk is now pursuing regulatory approval for semaglutide as a weight loss drug, other trials are ongoing. The Weight Management Center is currently recruiting participants for two trials – one with semaglutide is for people who have had a heart attack or stroke, and the other is testing a capsule that is swallowed before a meal, then swells up in the stomach to perhaps trigger the feeling of fullness more quickly.

O’Neil said they’re particularly looking for male volunteers, since men rarely volunteer for weight loss trials – in fact, 81% of participants in the overall semaglutide study were women – and participants from all ethnic and racial groups.

Wozniak said trials can be a great opportunity to reap the benefits of a new drug or protocol for free. Having worked as a research study coordinator for sickle cell trials at MUSC Health for six years, she’s familiar with clinical trial procedures and wasn’t worried about participating in a trial.

“For me personally, I thought that any potential risk was very much outweighed by how much I could improve my health by losing weight,” she said.

“I always felt very welcome.
I never felt judged."

Linda Wozniak
Trial Participant

For anyone considering signing up for a clinical trial, she noted that trials are completely voluntary for the entire duration of the study period. And, she added, the staff at the Weight Management Center made the experience pleasant.

“I always felt very welcome. I never felt judged,” she said.

That hasn’t always been the case for Wozniak. “I’ve definitely experienced bias from medical professionals in my life due to my weight, so it can create a sense of distrust. But it was really nice that when I had whatever issues come up during the study, I felt they weren’t just like, ‘Well you’re overweight, so that’s what caused that,’” she explained.

O’Neil added that even if people don’t feel comfortable with a trial, the center can still help. It offered online versions of its fee-for-service clinical programs long before COVID prompted everyone to go virtual and continues to do so as it has throughout the pandemic.

“We stand ready to serve everyone throughout the state of South Carolina, utilizing remote delivery of our programs and shipping meal replacement products as needed,” he said.