Status:
COMPLETED
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Lead Sponsor:
Saniona
Conditions:
Hypothalamic Injury-induced Obesity (HIO)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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), follow...
Detailed Description
Part 1 - the double-blind (DB) part: The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm will receive matching placebo ...
Eligibility Criteria
Inclusion
- 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
- Blood Pressure (BP) ≥160/90 mmHg
- Heart rate (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
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03845075
Start Date
February 25 2019
End Date
October 16 2020
Last Update
February 13 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rigshospitalet
Copenhagen, Denmark, 210