By Samantha Black, Ph.D.

A new phase 3 clinical trial expected to begin in late July 2019, will test an anti-obesity drug targeting people with rare genetic conditions, and will be tied to a genetic study attempting to create a more comprehensive understanding of the genes associated with obesity.

This trial will be conducted at The Alberta Diabetes Institute (ADI) and the results (to be completed by June 2020) will be shared with researchers in the United States and the United Kingdom.

Research in the past decades has identified that melanocortin-4 receptor (MC4R) agonists successfully instigate weight loss, but with the serious side effect of increased blood pressure. However, recent animal studies conducted at the University of Cambridge, identified nine MC4R variants with the potential to lower obesity without the risk of increased blood pressure. With this new evidence, Rhythm Pharmaceuticals, a Boston-based biopharmaceutical company focused on the treatment of rare genetic disorders of obesity, developed the candidate, setmelanotide, and began clinical trials in several populations with genetic disorders associated with obesity.

According to Rhythm, setmelanotide is an investigational, MC4R agonist used for the treatment of obesity in individuals with rare genetic disorders. This drug may activate the MC4R gene and is found to be involved in feeding behavior and regulation of metabolism, and in this case regulates weight by increasing energy expenditure and reducing appetite. This therapy will be targeted in individuals with Bardet-Biedl syndrome or Alström syndrome.

The study's primary efficacy endpoint will evaluate the proportion of patients who lose more than 10% of their baseline body weight following approximately 52 weeks of treatment with setmelanotide compared to a historical control rate. The study will consist of 3 treatment periods. Eligible patients will enter a 14 week, randomized, double-blind, placebo-controlled treatment period (Period 1) that will be followed by a 38 week open label treatment period (Period 2) in which all patients will receive setmelanotide. Period 3 will be a 14 week open-label treatment period.

This is an exciting time in anti-obesity research, as scientists work towards developing therapies to protect individuals against the disease of obesity in safe ways using novel genetic techniques. If this clinical trial is successful, then it could lead to the development of additional MC4R drugs and therapies in other populations, making a serious dent in the fight against obesity.


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