48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
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
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Tesofensine/Metoprolol vs Placebo; p = 0.4671; LS Mean Difference 3.60 (95% CI -6.58 to 13.78) NCT03845075 ↗
registry analysis (superiority test); Tesofensine/Metoprolol vs Placebo; p = 0.6543; LS Mean Difference -1.31 (95% CI -7.33 to 4.72) NCT03845075 ↗
registry analysis (superiority test); Tesofensine/Metoprolol vs Placebo; p = 0.7023; LS Mean Difference -1.35 (95% CI -8.67 to 5.97) NCT03845075 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metoprolol | Other / unclassified | 50 mg | — |
| Subject | Tesofensine | Small molecule | 0.5 mg | — |