The Alberta Diabetes Institute (ADI) will be the center to conduct a new clinical trial for an anti-obesity drug called setmelanotide, targeting patients with rare genetic conditions contributing to their obesity.
Dr. Andrea Haqq, Clinical Scientist at the ADI and Associate Professor at the University of Alberta’s Department of Pediatrics will lead the clinical trial, which will also be associated with a genetic study that has already been undergoing to develop a comprehensive picture of the genes linked to obesity.
“One thing that people don’t always recognize about obesity, especially childhood obesity, is that it is very complex. It’s not as simple as eating too much,” said Dr. Haqq. “One of those complex components is the genetic influences on obesity, which actually account for 60 to 70 percent of what sets our body mass index (BMI).”
Sponsored by Rhythm Pharmaceuticals, the clinical trial is expected to start in late July. Researchers will test the efficacy of setmelanotide on patients with obesity who have two rare genetic disorders attributing to obesity called Bardet-Biedl syndrome or Alström syndrome.
Previous studies conducted on obese adults with other rare genetic disorders have found that setmelanotide has profound effects on weight loss, with nearly 50 percent efficacy in a few cases.
Dr. Haqq said, “What’s really exciting about this drug is that this is one of the first anti-obesity drugs that doesn’t have the cardiovascular side-effects that previous drugs had. As we gain more experience with it, I’m hopeful this trial will make a big splash and lead to other trials for other populations.”
Along with this clinical trial, Dr. Haqq is also conducting a genetic screening test to understand the DNA of people who are obese and have been known to have increased appetite or excessive hunger. Dr. Haqq and her team will be seeking to add to the list of genes that are associated with obesity.
The researchers hope that the findings will help clinicians to recognize the physical signs and symptoms of genetic disorders that are contributing to obesity.
Dr. Haqq said, “Participants who have other genetic disorders linked to their obesity identified as part of the genetic study could be added to the anti-obesity drug trial in future expansions.” “We’re fortunate to have very skilled research coordinators with a lot of experience in running these types of trials. The ADI also has everything we need in one location so we can do all our work right here, and patients have only one place to come to,” added Dr. Haqq.