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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-02-13

Study results available
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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

Conditions

  • Hypothalamic Injury-induced Obesity (HIO)

Interventions

DRUG

Tesofensine/Metoprolol

During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication)

DRUG

Placebo

During Part 1 subjects will be randomized to matching placebo tesofensine and placebo metoprolol

Sponsors & Collaborators

  • Saniona

    lead INDUSTRY

Principal Investigators

  • Ulla Feldt-Rasmussen, MD, DMSc · Department of Medical Endocrinology and metabolism Rigshospitalet,Copenhagen, DK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845075 on ClinicalTrials.gov