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The Alberta Diabetes Institute (ADI) of the University of Alberta is about to conduct a clinical trial of the new drug setmelanotide for the treatment of obesity badociated with rare genetic diseases at the University of Alberta. Canada.
The international study, scheduled to start at the end of the month, is funded by Rhythm Pharmaceuticals, the company that developed setmelanotide as a melanocortin-4 receptor agonist (MC4R). .
It is thought that MC4R stimulates a biological pathway that regulates weight in humans. Variants of the MC4R pathway may lead to excessive hunger (hyperphagia) and severe early obesity.
Setmelanotide is intended to serve as a potential replacement therapy for restoring the activity of the lost MC4 pathway to regain control of weight and appetite in patients with rare genetic diseases.
The new study will evaluate the drug for more than a year in patients with Bardet-Biedl syndrome or Alström syndrome, which are rare genetic diseases characterized by obesity.
Participants will initially be randomized to receive setmelanotide or placebo for 14 weeks before receiving treatment with the drug for 38 weeks.
The main measure of the trial is the proportion of patients who lose 10% or more of their body mbad after 52 weeks.
Andrea Haqq, clinical researcher at ADI, said, "What's really interesting about this drug is that it's the first anti-obesity drug that does not have the cardiovascular side effects that previous medications .
"As we gain more experience, I hope this test will make waves and lead to further trials for other populations."
The institute will act as a coordination center and will recruit and supervise other sites in Canada.
In addition to the clinical trial, ADI is also conducting a genetic study to badyze the DNA of children and adults suffering from obesity and overeating.
Individuals identified as having obesity related to their genetic disorders, other than Bardet-Biedl syndrome or Alström syndrome, could be enrolled in the future in the setmelanotide clinical trial.
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