The Alberta Diabetes Institute (ADI) will be at the center of a new clinical trial for an anti-obesity drug aimed at people with rare genetic conditions that contribute to their obesity. Led by Andrea Haqq, an ADI clinical scientist and associate professor at the Department of Pediatrics at the University of Alberta, the drug test will also be linked to a genetic study that is already trying to create a more complete image of genes which are related to obesity. .
"Something that people do not always recognize about obesity, especially childhood obesity, is that it is very complex. It's not as simple as eating too much," said Haqq. "These complex components are genetic influences in obesity, which really represent between 60 and 70 percent of what marks our body mass index (BMI)."
The clinical trial, sponsored by Rhythm Pharmaceuticals and which will begin at the end of July, will test the effects of Dermaloxide in obese participants who have Bardet-Biedl syndrome or Alström's syndrome, two rare genetic diseases that include Obesity as a symptom. In the studies on adults with obesity with other rare genetic disorders, it was found that setmelanotides had a profound effect on weight loss, almost 50% in some cases.
"What is really exciting about this drug is that this is one of the first anti-obesity medications that does not have the cardiovascular side effects that had the previous medications," he said. "As we gain more experience with him, I have the hope that this trial will make a great wave and will lead to other trials for other populations."
The trial will last one year. After a two to three week selection phase, participants will be part of a 14-week double blind trial with the medication and a placebo before moving on to a 38-week treatment with the medication. Haqq said: "The main measure at the end of the study will be the proportion of participants who lose 10% of their body mass or more after 52 weeks."
Along with the drug trial, Haqq is also conducting a genetic screening study to analyze the DNA of obese children and adults who have been identified as hyperphagia or with excessive hunger. Throughout the study, the Haqq team is trying to add to the list of genes that are associated with obesity. It is hoped that the results will help physicians to better recognize the physical signs of genetic disorders that contribute to patient obesity, including symptoms, medical history and family history. Participants who have other genetic disorders linked to their obesity identified as part of the genetic study could be added to the trial against obesities in future expansions, said Haqq.
The ADI is the main Canadian coordination center for the drug trial, responsible for hiring and overseeing other sites across Canada as it expands. Haqq will also coordinate its findings with its counterparts in the United States and in the United Kingdom.
"We are fortunate to have highly specialized research coordinators with a lot of experience in the execution of this type of testing," he said. "ADI also has everything we need in one place so we can do all our work right here, and patients only have a place to get there."
Faculty of Medicine and Dentistry of the University of Alberta