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Clinical Trials

Date: 2017-12-12

Type of information: Presentation of results at a congress

phase: 2a

Announcement: presentation of results at the European Association for the Study of Diabetes, EASD congress 2017

Company: Saniona (Denmark)

Product: Tesomet® (tesofensine and metoprolol)

Action mechanism:

  • monoamine uptake inhibitor/Beta-blocker. Tesomet® is a fix-dosed combination of tesofensine and metoprolol. Tesofensine provides robust weight loss in obese patients and in addition to treatment of obesity, tesofensine also has the potential to reverse the progression of type 2 diabetes by reducing liver fat. In general, tesofensine has been well tolerated in human clinical studies. However, an increase in heart rate has been observed at therapeutic relevant doses of tesofensine.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country:

Trial details:

Latest news:

  • • On September 12, 2017, Saniona announced that data from its Phase 2a study with Tesomet in type 2 diabetes has been selected for two poster presentations at the European Association for the Study of Diabetes, EASD congress 2017 taking place in Lisbon, Portugal. Results from this study confirmed that addition of metoprolol to tesofensine fully mitigates the increase in heart rate and blood pressure previously observed with tesofensine. In addition, the data showed a robust weight loss and reduction in waist circumference as well as numerical reduction in liver fat in patients with type 2 diabetes coupled with a favourable toleration and safety profile. These results, together with data from previous clinical studies with tesofensine supports the use of Tesomet as a safe and effective weight loss drug in patients with metabolic disorders like diabetes and obesity. As a result, Saniona has initiated the preparation for long term clinical studies for metabolic diseases as well as eating disorders.
  • Poster #857: Co-administration of tesofensine/metoprolol: Improvement in heart rate with significant body weight reduction in overweight or obese subjects with type 2 diabetes Authors: Roman V. Dvorak, Grit Andersen, Berit Edsberg, Pavlína Kašparová, Jorge Arrubla, Leona Plum-Mörschel
  • Poster #851 : Co-administration of tesofensine/metoprolol: Improvements in body weight and liver fat content in overweight or obese subjects with type 2 diabetes Authors: Grit Andersen, Tim Heise, Berit Edsberg, Daniela Lamers, Thomas A. Jacobsen, Leona Plum-Mörschel, Roman V. Dvorak
 

Is general: Yes