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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03845075 (opens ClinicalTrials.gov in a new tab)Other idTM005
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
21 participants (actual)
Sponsor
Saniona · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
25 Feb 2019
Primary completion
16 Oct 2020
Completion
16 Oct 2020
First posted
19 Feb 2019
Last update posted
13 Feb 2024
Conditions
Hypothalamic Injury-induced Obesity (HIO)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

    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

    25 Feb 2019 to 16 Oct 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Tesofensine/MetoprololDrug
  • PlaceboDrug

Arms2

  • Experimental

    active arm

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

  • Placebo comparator

    placebo arm

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

Primary outcomes9

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment Emergent Adverse Events

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of participants with adverse events in each of the two treatment arms

  2. Number of Participants With at Least One Mild, Moderate or Severe Adverse Event

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of participants with mild, moderate or severe adverse events in each of the two treatment arms.

  3. Participants (Number and Percentage) With and Type of Serious Adverse Events

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of participants with at least one serious adverse event, indicating type, in each of the two treatment arms

  4. Safety as Assessed by Systolic Blood Pressure [mmHg]

    Time frame · from Baseline to week 24

    Registry description

    Systolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  5. Safety as Assessed by Diastolic Blood Pressure [mmHg]

    Time frame · from Baseline to week 24

    Registry description

    Diastolic blood pressure in mmHg measured at each visit in each of the two treatment arms

  6. Safety as Assessed by Heart Rate [Bpm]

    Time frame · from Baseline to week 24

    Registry description

    Heart rate measured in beats per minute (bpm) at each visit in each of the two treatment arms

  7. Safety as Assessed by Hematology Parameters

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for hemoglobin, platelet counts, white cells count, differential counts at baseline, week 12 and week 24 in each of the two treatment arms

  8. Safety as Assessed by Electrolytes and Creatinine

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for sodium, potassium, creatinine at each visit in each of the two treatment arms

  9. Safety as Assessed by Liver and Kidney Function Tests

    Time frame · from Baseline to week 24

    Registry description

    Number and percentage of deviations from normal range (as defined by the investigational site's laboratory) for gamma glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), glomerular filtration rate (GFR), and urea at baseline, week 12, and week 24 in each of the two treatment arms

Secondary outcomes(17)

  1. Composite Satiety Score (CSS)

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry 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)

  2. Body Weight

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry 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

  3. Body Composition - Fat Mass

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry 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. mITT observed values.

  4. Body Composition - Lean Body Mass

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry 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. mITT observed values.

  5. Glycemic Control - HbA1c

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in HbA1c from baseline to week 24, baseline to week 48 and week 24 to week 48 for each of the two treatment arms. mITT observed values.

  6. Glycemic Control - Fasting Plasma Glucose

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in fasting plasma glucose from baseline to week 24, baseline to week 48 and week 24 to week 48 measured at each visit for each of the two treatments arms. mITT observed values.

  7. Craving for Something Sweet, Salty, Meat/Fish, or Fatty

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in craving for something sweet, salty, meat/fish, or fatty by the use of visual analogue scales (VAS) from baseline to week 24, from baseline to week 48, and from week 24 to week 48 The VAS consisted of a 100-mm horizontal line; subjects placed a vertical line on the VAS to indicate the level of intensity of their food craving. The VAS value is the distance in mm (0-100 mm) from the left end of the line to the subject's vertical line (higher value represents less craving). mITT observed values.

  8. Thirst

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in thirst by the use of a visual analog scale (VAS) from baseline to week 24, from baseline to week 48, and from week 24 to week 48 The VAS consisted of a 100-mm horizontal line; subjects placed a vertical line on the VAS to indicate the level of intensity of their thirst. The VAS value is the distance in mm (0-100 mm) from the left end of the line to the subject's vertical line (higher value represents an increase in perception of thirst). mITT observed values.

  9. Waist Circumference

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in waist circumference from baseline to week 24, from baseline to week 48, and from week 24 to week 48. mITT observed values.

  10. Lipid Profile

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in lipid profile from baseline to week 24, from baseline to week 48, and from week 24 to week 48. mITT observed values.

  11. Quality of Life - SF-36

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in quality of life by use of the Short Form 36 Health Survey (SF-36) scores from baseline to week 24, from baseline to week 48, and from week 24 to week 48 The physical component summary score includes the aggregated scores for scales of physical functioning, role-physical, bodily pain, and general health. The mental health component summary score includes the aggregated scores for scales of vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100; higher score indicates better health. mITT observed values.

  12. Number of Participants With Adverse Event(s) and/or Serious Adverse Event(s) - Open-label Extension

    Time frame · from week 24 to week 48

    Registry description

    Number of participants with adverse event(s) and/or serious adverse event(s) reported from week 24 to week 48

  13. Blood Pressure (Change)

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in blood pressure from baseline to week 24, from baseline to week 48, and from week 24 to week 48. mITT observed values.

  14. 24 Hours Blood Pressure

    Time frame · from baseline to week 12 and baseline to week 24

    Registry description

    Changes in 24 hours blood pressure from baseline to week 12 and baseline to week 24

  15. Plasma Trough Concentrations

    Time frame · baseline to week 48

    Registry description

    Plasma trough concentrations of tesofensine, metabolite NS2360 and metoprolol for the active arm (the first 24 weeks and then continuously up to week 48) and placebo arm (start of treatment at week 25 and then continuously up to week 48). mITT observed values.

  16. 48 Hours Heart Rate and QT Interval at Baseline, Week 12 and Week 24

    Time frame · baseline, week 12 and week 24

    Registry description

    For Part 1, 48 hours HR and QT interval from week 12 to week 24 were not recorded in the database and analysis of changes not evaluated. Instead, abnormal findings over visits were summarized. Abnormal ECG findings detected in the three Tesomet treated subjects are: * QTc prolongation (466 ms) * Bradycardia (56 bpm) * QTc prolongation (460 ms) All were considered not clinically significant.

  17. Heart Rate (Change)

    Time frame · from baseline to week 24, from baseline to week 48 and from week 24 to week 48

    Registry description

    Change in heart rate from baseline to week 24, from baseline to week 48, and from week 24 to week 48. mITT observed values.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· from Baseline to week 24

Number of Participants With Treatment Emergent Adverse Events

GroupValue (Participants)
Tesofensine/Metoprolol12
Placebo7
Primary outcomeCount of participants· from Baseline to week 24

Number of Participants With at Least One Mild, Moderate or Severe Adverse Event

GroupValue (Participants)
Tesofensine/Metoprolol11
Placebo7
Primary outcomeCount of participants· from Baseline to week 24

Participants (Number and Percentage) With and Type of Serious Adverse Events

GroupValue (Participants)
Tesofensine/Metoprolol2
Placebo1
Primary outcomeMean· from Baseline to week 24

Safety as Assessed by Systolic Blood Pressure [mmHg]

GroupValue (mmHg)Spread
Tesofensine/Metoprolol124.09
Placebo134.516
Primary outcomeMean· from Baseline to week 24

Safety as Assessed by Diastolic Blood Pressure [mmHg]

GroupValue (mmHg)Spread
Tesofensine/Metoprolol83.214
Placebo85.98
Primary outcomeMean· from Baseline to week 24

Safety as Assessed by Heart Rate [Bpm]

GroupValue (bpm)Spread
Tesofensine/Metoprolol75.58
Placebo78.911
Primary outcomeCount of participants· from Baseline to week 24

Safety as Assessed by Hematology Parameters

GroupValue (Participants)
Tesofensine/Metoprolol0
Placebo0
Primary outcomeCount of participants· from Baseline to week 24

Safety as Assessed by Electrolytes and Creatinine

GroupValue (Participants)
Tesofensine/Metoprolol0
Placebo0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Tesofensine/MetoprololSubjects were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication) once daily for 24 weeks during Part 1.0 / 142 / 1412 / 14
PlaceboSubjects were randomized to receive matching placebo tablets once daily for 24 weeks during Part 1.0 / 81 / 87 / 8
Tesofensine/Metoprolol -> Tesofensine/MetoprololSubjects who received co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication) once daily for 24 weeks during Part 1 continued to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol once daily for an additional 24 weeks in Part 2.0 / 111 / 1111 / 11
Placebo -> Tesofensine/MetoprololSubjects who received matching placebo tablets once daily for 24 weeks during Part 1 were switched to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol once daily for an additional 24 weeks in Part 2.0 / 60 / 66 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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