WeightControl.com: What are the main findings?
Response: The positive Phase 2 results presented at The Obesity Society’s ObesityWeek® 2022 conference show a mean body mass index (BMI) reduction of -14.5 percent at 16 weeks on setmelanotide therapy; 89 percent (16 of 18) of patients treated with setmelanotide achieved the primary endpoint with a BMI decrease greater than 5 percent at 16 weeks. Long-term data show sustained and increasing weight loss with a mean BMI reduction of -26.7 percent in patients who reached 41 weeks on therapy.
WeightControl.com: What should readers take away from your report?
Response: We have used different drugs in the past and we have not seen such a strong response to a drug intervention before. In talking with patients and their families it was very clear there was a significant change in eating behavior and their desire to eat. They were able to stay away from food for a longer time. For some of the patients that was really changing their lives. They are back to normal and not obsessed with food all the time.
WeightControl.com: What recommendations do you have for future research as a result of this work?
Response: This affects a large age range, and as a clinician I am really glad to see that we can offer this clinical research opportunity to a larger portion of our patients and that there are different tumor entities included, not just patients with craniopharyngioma, which is the most common tumor leading to hypothalamic obesity. I think it is reasonable to have a goal of quick enrollment in a Phase 3 clinical trial to further evaluate setmelanotide in hypothalamic obesity.
WeightControl.com: Is there anything else you would like to add? Any disclosures?
Response: These patients are very motivated. There is no way to treat them now. So even if we can stabilize their BMI, that is already a success because they were experiencing a steep increase in BMI before.
The Phase 2 clinical trial was sponsored by Rhythm Pharmaceuticals, Inc.
- Abstract resented at ObesityWeek 2022 sponsored by The Obesity SocietyPoster #176 , “Efficacy and Safety Analysis of Setmelanotide As a Novel Treatment for Hypothalamic Obesity,” on Nov. 2, 2022
2. Rhythm Pharmaceuticals Announces Setmelanotide Granted Breakthrough Therapy Designation for Hypothalamic Obesity by the U.S. FDA
November 1, 2022
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