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

• Status: Completed
• Trial end date: 2020-10-16
• Target enrollment: 0
• Participant gender: All

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, followed by

• Part 2: 24 weeks open-label extension - 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saniona
• Treatments: Metoprolol

Criteria

Inclusion Criteria:

• Informed consent obtained before any trial-related activities

• Males and females, aged 18-75

• Confirmed diagnosis of HIO

• BMI ≥27 kg/m2 (where overweight is related to the HIO)

Exclusion Criteria:

• BP ≥160/90 mmHg

• HR ≥ 90, <50 bpm

• Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome

• Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure

• Previous myocardial infarction or stroke within the last 5 years