The Alberta Diabetes Institute (ADI) plans on conducting an anti-obesity drug clinical trial for those with rare genetic conditions that contribute to their obesity. The Canadian team will test the effectiveness of setmelanotide (Rhythm Pharmaceutical) on participants with obesity who have either Bardet-Biedl syndrome or Alström syndrome, two rare diseases that include obesity as a symptom.

The Study

Scheduled to begin in late July, Alberta Diabetes Institute (ADI) will conduct the study sponsored by Rhythm Pharmaceuticals. The clinical investigative team will test the effectiveness of setmelanotide on participants with obesity who have either Bardet-Biedl syndrome or Alström syndrome. This trial is also tied into an ongoing genetic study attempting to create a more comprehensive picture of the genes that are linked to obesity.

The trial will run over the course of a year. After a two-to-three-week screening phase, participants will be part of a 14-week double blind test with the drug and a placebo before moving to a 38-week treatment with the drug. The primary measure at the end of the study will be the proportion of participants who lose 10 percent of their body mass or more after 52 weeks.

Along with the drug trial, the principal investigator is also conducting a genetic screening study to analyze the DNA of children and adults who are obese, and have been identified as having hyperphagia, or excessive hunger. Through the study, Haqq’s team is seeking to add to the list of genes known to be associated with obesity. It’s hoped the findings will help physicians better recognize the physical signs of genetic disorders contributing to a patient’s 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 anti-obesity drug trial in future expansions.

About Setmelanotide

It is a peptide dug and investigational anti-obesity medication which acts as a selective agonist of the MC4 receptor. The company behind the drug is Rhythm Pharmaceuticals, a Boston-based biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity.

The Alberta Diabetes Institute

A research facility on the University of Alberta campus dedicated to translating discovery science into health solutions for the prevention, treatment and cure of diabetes. The 200,000 square foot institute was established in 2007 as a stand-alone facility to consolidate the University’s outstanding collection of diabetes researchers and their trainees.

Lead Research/Investigator

Andrea Haqq, Associate Professor, Department of Pediatrics, University of Alberta

Source: EurekAlert!

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