Trial Profile

A pivotal clinical trial of Tesomet for hypothalamic obesity

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 17 Mar 2021

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At a glance

Drugs Metoprolol/tesofensine (Primary)
Indications Obesity
Focus Registrational; Therapeutic Use
Sponsors Saniona

Most Recent Events

08 Mar 2021 According to a Saniona media release, The agency (FDA) stated that robust data from these analyses (mentione the analysis) could be useful in determining the level of cardiovascular assessment needed in Phase 3. The agency also acknowledged the challenge of conducting 24-hour monitoring in HO patients and said the analyses could be conducted in a separate study in general obese people.
26 Jun 2020 New trial record
22 Jun 2020 According to a Saniona media release, the company plans to initiate this pivotal trial in the next 12 months.

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