Therapy Areas: Central Nervous System
Saniona reports on recruitment of first hypothalamic obesity patients in phase 2a clinical study of Tesomet
12 March 2019 -

Saniona AB (STO:SANION), a biotechnology company focused on the central nervous system and eating disorders, announced on Monday the recruitment of the first patient in a phase 2a clinical study of Tesomet to treat the rare eating disorder, hypothalamic obesity.

This trial comprised of a total of up to 25 patients and is conducted at Rigshospitalet in Copenhagen, Denmark. Reportedly, the purpose of this study is to investigate the overall safety and tolerability as well as effect on satiety, appetite and weight loss of Tesomet in patients with hypothalamic obesity.

In this exploratory randomised, double-blind, placebo-controlled study, patients will receive either Tesomet (tesofensine 0.5 mg + metoprolol 50 mg daily) or matching placebo (2:1 randomisation) for 24 weeks followed by an open-label extension study where all patients will receive Tesomet for 24 weeks, resulting in a total treatment period of 48 weeks. Saniona expects to report the results from the double-blind part of the study in Q4 2019 and the full study in H1 2020.

The primary endpoint is overall safety and tolerability, which will be judged from all safety data collected during the study, including recorded adverse events, laboratory data, blood pressure and heart rate. The secondary endpoints examine Tesomet's effects on satiety and appetite; bodyweight; body composition; lipids and metabolic parameters; quality of life; and craving for sweet, salty and fatty foods.