drugset / Trial / NCT03845075

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)

NCT03845075

Phase 2 Completed 21 enrolled Saniona
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period. • The study will have two parts: * Part 1: 24 weeks double-blind treatment (DB), followed by * Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator

Timeline

Start
2019-02-25
Primary completion
2020-10-16
Completion
2020-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Metoprolol Other / unclassified 50 mg
Subject Tesofensine Small molecule 0.5 mg