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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)

Primary Purpose

Hypothalamic Injury-induced Obesity (HIO)

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Tesofensine
Placebo
Sponsored by
Saniona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothalamic Injury-induced Obesity (HIO)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active arm

placebo arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency of treatment emergent adverse events
Number and percentage of adverse events in each of the two treatment arms
Severity of treatment emergent adverse events
Number and percentage of mild, moderate and severe adverse events in each of the two treatment arms
Frequency and type of serious adverse events
Number, percentage and type of serious adverse events in each of the two treatment arms
Safety as assessed by systolic blood pressure [mmHg]
Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms
Safety as assessed by diastolic blood pressure [mmHg]
Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms
Safety as assessed by heart rate [b/min]
Heart rate measured in bpm at each visit in each of the two treatment arms
Safety as assessed by hematology parameters
Number and percentage of deviations from normal range for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 14 and week 24 in each of the two treatment arms
Safety as assessed by electrolytes and creatinine
Number and percentage of deviations from normal range for sodium, potassium, creatinine at each visit in each of the two treatment arms
Safety as assessed by liver and kidney function tests
Number and percentage of deviations from normal range for gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, glomerular filtration rate and urea at baseline, week 14 and week 24 in each of the two treatment arms

Secondary Outcome Measures

Composite satiety score (CSS)
Change in satiety and appetite using the CSS from Baseline to week 24, from Baseline to week 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms Full name of the scale: composite satiety score (CSS), sometimes referred to as "appetite suppression score". Range of values is 0-100; lower the value, hungrier a person is. CSS = (satiety + fullness + [100 - hunger] + [100 - prospective food consumption]) / 4. The four variables included are measured by visual analog scales (0-100 mm)
Body weight
Change in body weight from baseline to week 24, from baseline to 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms
Body composition - fat mass
Change in body fat mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms
Body composition - lean body mass
Change in lean body mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms
Glycemic control - HbA1c
Change in HbA1c from baseline to week 24, baseline to week 48 and week 24 to week 48 measured at baseline, week 14, week 24, week 36 and week 48 for each of the two treatment arms
Glycemic control - Fasting Plasma Glucose
Change in fasting plasma glucose from baseline to week 24, baseline to week 48 and week 24 to wee 48 measured at each visit for each of the two treatments arms

Full Information

First Posted
January 30, 2019
Last Updated
January 7, 2021
Sponsor
Saniona
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1. Study Identification

Unique Protocol Identification Number
NCT03845075
Brief Title
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Official Title
A 24-week Phase 2, Double-blind, Randomized, Placebo- Controlled, Single-center Safety and Efficacy Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO), and With a 24-week Open-label Extension, in Total 48 Weeks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
October 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saniona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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
Detailed Description
Part 1 - the double-blind 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothalamic Injury-induced Obesity (HIO)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active arm
Arm Type
Experimental
Arm Description
The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.
Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
The placebo arm will receive matching placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Tesofensine
Intervention Description
During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
During Part 1 subjects will be randomized to matching placebo treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol
Primary Outcome Measure Information:
Title
Frequency of treatment emergent adverse events
Description
Number and percentage of adverse events in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Severity of treatment emergent adverse events
Description
Number and percentage of mild, moderate and severe adverse events in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Frequency and type of serious adverse events
Description
Number, percentage and type of serious adverse events in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by systolic blood pressure [mmHg]
Description
Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by diastolic blood pressure [mmHg]
Description
Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by heart rate [b/min]
Description
Heart rate measured in bpm at each visit in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by hematology parameters
Description
Number and percentage of deviations from normal range for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 14 and week 24 in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by electrolytes and creatinine
Description
Number and percentage of deviations from normal range for sodium, potassium, creatinine at each visit in each of the two treatment arms
Time Frame
from Baseline to week 24
Title
Safety as assessed by liver and kidney function tests
Description
Number and percentage of deviations from normal range for gamma glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, glomerular filtration rate and urea at baseline, week 14 and week 24 in each of the two treatment arms
Time Frame
from Baseline to week 24
Secondary Outcome Measure Information:
Title
Composite satiety score (CSS)
Description
Change in satiety and appetite using the CSS from Baseline to week 24, from Baseline to week 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms Full name of the scale: composite satiety score (CSS), sometimes referred to as "appetite suppression score". Range of values is 0-100; lower the value, hungrier a person is. CSS = (satiety + fullness + [100 - hunger] + [100 - prospective food consumption]) / 4. The four variables included are measured by visual analog scales (0-100 mm)
Time Frame
from baseline to week 48
Title
Body weight
Description
Change in body weight from baseline to week 24, from baseline to 48 and from week 24 to week 48 measured at each visit for each of the two treatment arms
Time Frame
from baseline to week 48
Title
Body composition - fat mass
Description
Change in body fat mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms
Time Frame
from baseline to week 48
Title
Body composition - lean body mass
Description
Change in lean body mass as measured in kg by DXA scan measured at baseline, week 24 and week 48 for each of the two treatment arms
Time Frame
from baseline to week 24, from baseline to week 48 and from week 24 to week 48
Title
Glycemic control - HbA1c
Description
Change in HbA1c from baseline to week 24, baseline to week 48 and week 24 to week 48 measured at baseline, week 14, week 24, week 36 and week 48 for each of the two treatment arms
Time Frame
from baseline to week 48
Title
Glycemic control - Fasting Plasma Glucose
Description
Change in fasting plasma glucose from baseline to week 24, baseline to week 48 and week 24 to wee 48 measured at each visit for each of the two treatments arms
Time Frame
from baseline to week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulla Feldt-Rasmussen, MD, DMSc
Organizational Affiliation
Department of Medical Endocrinology and metabolism Rigshospitalet,Copenhagen, DK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
210
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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