Ulla Feldt-Rasmussen, MD, Department of Medical Endocrinology and Metabolism, Rigshospitalet Copenhagen University Hospital, discusses results from a phase 2 open-label extension study of tesomet to treat patients with hypothalamic obesity (HO).
HO is a rare endocrine disorder characterized by severe and debilitating obesity. Signs and symptoms of hypothalamic obesity include excessive appetite, inability to feel full, and rapid weight gain. Additionally, people with HO tend to have a low metabolic rate, decreased physical activity, and excessive daytime sleepiness. Currently, there are no approved treatments specifically for HO. Standard treatment approaches for HO such as surgery, medication and lifestyle counseling have been mostly ineffective.
In April 2020, Saniona reported positive results from part 1 of their phase 2 trial of tesomet in HO. Part 1 of the trial involved double-blind treatment for 24 weeks. The results demonstrated that tesomet was safe and well-tolerated. Furthermore, statistically significant improvements in body weight, waist circumference, and glycemic control observed with Tesomet treatment compared to placebo were also reported. Recently, Saniona has reported positive results from part 2 of the study which was an open-label extension study where all active participants from part 1 were given the drug for an additional 24 weeks. Tesomet was found to be well-tolerated in HO patients throughout the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. Patients who received tesomet for the full 48 weeks demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference from baseline to Week 48, as well as improvements in glycemic control. Patients who received placebo in the double blind period and switched to tesomet during the open label extension period also achieved reductions in body weight and waist circumference after being switched to tesomet.
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