Clinical trial of a new anti-obesity drug ready to be launched at the University of Alberta

The Alberta Diabetes Institute (ADI) will be at the center of a new clinical trial of an anti-obesity drug for people with rare genetic diseases that contribute to their obesity. Led by Andrea Haqq, Clinical Scientist at ADI and Associate Professor in the Department of Pediatrics of the University of Alberta, the study will also be linked to an ongoing genetic study aimed at creating a more complete picture of genes related to obesity. .

"One thing that people do not always recognize about obesity, especially childhood obesity, is that it's very complex. It's not that simple than overeating, "Haqq said. "One of these complex components is the genetic influence on obesity, which actually accounts for 60 to 70% of what defines our body mbad index (BMI)."

The clinical trial, sponsored by Rhythm Pharmaceuticals and expected to begin at the end of July, will test the effects of setmelanotide on obese participants with Bardet-Biedl syndrome or Alström syndrome, two rare genetic diseases whose obesity is a symptom. In studies on adults suffering from obesity and presenting with other rare genetic disorders, it has been found that setmelanotide has a profound effect on weight loss – almost 50% in some cases.

"What's really exciting about this medication is that it's one of the first anti-obesity drugs that does not have the cardiovascular side effects of previous medications," he said. she said. "As we gain more experience, I hope this essay will make waves and lead to further trials for other populations."

The trial will take place over a year. After a screening phase of two to three weeks, participants will participate in a 14-week double-blind test with the drug and a placebo before switching to a 38-week treatment with the drug. The main measure at the end of the study will be the proportion of participants who lose 10% or more of their body mbad after 52 weeks, Haqq said.

Along with the drug trial, Haqq is also conducting a genetic screening study to test the DNA of obese children and adults who have been identified as suffering from overeating or excessive hunger. Through this study, the Haqq team seeks to add to the list of genes known to be badociated with obesity. We hope the results will help physicians better recognize the physical signs of genetic disorders contributing to the patient's obesity, including symptoms, medical history and family history. Participants who have other genetic disorders related to their obesity identified as part of the genetic study could be added to the anti-obesity drug trial in future extensions, Haqq said.

The ADI is Canada's primary center for drug testing coordination. She is responsible for recruiting and supervising other sites across Canada as the trial develops. Haqq will also coordinate its findings with counterparts in the United States and the United Kingdom.

"We are fortunate to have very competent research coordinators who are experienced in conducting this type of testing," she said. "The ADI also has everything we need in one place, allowing us to do all our work right here, and patients have only one place."

Supplied by the Faculty of Medicine and Dentistry of the University of Alberta