Patients treated with Tesomet for nearly one year (24 week double-blind [DB] followed by 24 week open label extension [OLE]) demonstrated statistically significant and clinically meaningful reductions in body weight and waist circumference, as well as improvements in glycemic control. No clinically meaningful differences in heart rate or blood pressure were observed over the course of the trial.
'Hypothalamic obesity is a rare disorder characterized by severe and debilitating obesity that is often complicated by depression, impulse control issues, complicated symptoms from necessary replacement of pituitary hormones, and increased risk of cardiometabolic disorders. There are no treatments specifically approved for HO, and standard weight loss approaches such as surgery, medication and lifestyle counseling are mostly ineffective in this rare disease,' said Professor
'The results of the open-label extension study reinforce the promising profile of Tesomet observed in the placebo-controlled portion of the Phase 2 study in patients with hypothalamic obesity,' said
About the Phase 2 Study
This randomized, double-blind, placebo-controlled Phase 2 study evaluated Tesomet administered daily in patients with HO. The primary endpoint of the study was overall safety and tolerability measured by all safety data collected during the study including recorded adverse events, laboratory data, blood pressure, and heart rate. The secondary efficacy endpoints included bodyweight, waist circumference, glycemic control and other measures. In the double-blind (DB) period of the study, patients received either Tesomet or matching placebo (2:1 randomization) for 24 weeks. A total of 21 patients (13 Tesomet, 8 placebo) were included within the modified intent-to-treat analysis pertaining to the DB period. Top-line results from the DB period were announced in a press release in
All 18 patients who completed the DB period of the study were provided the opportunity to receive Tesomet in an open-label extension (OLE) period of the study for an additional 24 weeks. All 18 patients chose to participate in the OLE period, and all patients completed the OLE period. Patients entering the OLE were 83.3% female and on average 44.9 years old, weighing 110.4 kg (243 lbs) with a BMI of 37.2 kg/m2. Further details about the trial can be found at ClinicalTrials.gov.
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About
About Tesomet
Tesomet is an investigational fixed-dose combination therapy of tesofensine (a triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker).
About Hypothalamic Obesity (HO)
Hypothalamic obesity (HO) is a rare disorder characterized by intractable weight gain and uncontrollable hunger. Additional symptoms may include memory impairment, attention deficit, impulse control and depression as well as increased risk of cardiovascular and metabolic disorders. Currently, there is no cure for this condition. Treatments used for general weight management such as surgery, medication and lifestyle counseling are often tried in HO, but are mostly ineffective, and there are no medications specifically approved for HO. HO is caused by damage to the hypothalamus, most commonly sustained during surgery to remove a rare, noncancerous tumor called a craniopharyngioma. This tumor can occur at any age, but is most common in children and older adults, creating a burden for both patients and families. HO occurs in approximately one out of every 50,000 to 100,000 people.
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