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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2020-10-16

Brief Summary

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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

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Detailed Description

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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 tablets.

Part 2 - the open-label extension (OLE) part: All active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Conditions

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Hypothalamic Injury-induced Obesity (HIO)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active arm

The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Group Type EXPERIMENTAL

Tesofensine/Metoprolol

Intervention Type DRUG

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

placebo arm

The placebo arm will receive matching placebo tesofensine and placebo metoprolol.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tesofensine/Metoprolol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No