To help combat the obesity epidemic, investigators at Baylor seek overweight, non-diabetic men and women for a new research study focused on weight loss. The study, which mixes a well-known traditional therapy with an innovative new one, could help identify safe weight loss strategies for people whose body mass index (BMI) falls between 30 and 50.
Led by Priscilla Hollander, MD, researcher at the Baylor Endocrine Center, the study offers obese individuals a chance to take part in a large-scale national research effort while staying in the Dallas-Fort Worth (DFW) area. In exchange, selected participants receive free study-related medical tests and weight loss counseling.
“We’re so pushed to find effective methods of helping people lose weight,” said Dr. Hollander, who has led clinical trials for obese diabetics and non-diabetics for 20 years. “It’s difficult, because even though there are a couple of new drugs out that have been helpful, they haven’t made a huge impact.”
Through this effort, investigators will determine if the combination of canagliflozin (a diabetes drug) and phentermine (a weight loss pill) supports a safe change in body weight over a 26-week period. Both drugs are already approved by the FDA. In early testing, the combination successfully attacked weight gain in two different, but supplementary, ways.
“We find that one drug alone to lose weight just doesn’t seem to work as well,” Dr. Hollander said. “The problem with weight is that there are so many pathways in the body that play a role in weight gain. If you block one pathway, another may take over.”
Some may recognize phentermine from its role as the innocent partner in fenfluarmine/phentermine (“fen-phen”), a popular 1990s weight loss drug that was dropped because of fenfluarmine’s fatal side effects. Fen-phen resulted in rapid weight loss because it, too, was a multi-drug combo. By itself, phentermine showed no harmful effects and is still used today as a safe appetite suppressant, but results tend to be modest and people often regain the lost weight.
As the newer half of the old drug/new drug blend, canagliflozin received FDA approval in March 2013 for diabetics to reduce blood sugar. The drug works by helping the kidneys extract sugar from the blood. In non-diabetics, canagliflozin does not trigger low blood sugar.
“They saw when they were testing [canagliflozin] that the drug did have positive effects on blood sugar, but also that people did lose some weight,” Dr. Hollander said. “When they were developing this class of drugs [for diabetes], they looked at doing small studies to develop it as a weight loss drug.”
Fast-forward nearly two years, and those small studies have evolved into this national trial with an intended 344 participants across 19 research centers. Dallas and Odessa are the only two cities in Texas where the trial is available.
To continue DFW's involvement, Dr. Hollander’s team needs up to 30 obese men and women between the ages of 18 and 65. Diabetics will not be considered.
Since both drugs are currently FDA-approved individually and the research doesn’t involve new drug development, the go-to-market process could be faster than usual. If the trials show promising results for the canagliflozin/phentermine combo, Dr. Hollander said, the potent drug mix could be available to the general public in as little as a year.
More than 1 out of 3 U.S adults suffers from obesity, a serious health risk that can cause chronic problems, including diabetes, heart disease and cancer. Studies such as this one help address those emerging problems within structured research overseen by the FDA and regulated by the Institutional Review Board.
For enrollment information or to learn more, call 214-818-7155 or email researchtrials@baylorhealth.edu.
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About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com