Co-administration of Tesofensine/Metoprolol in Subjects W... | NCT03149445 | Trialant
NCT03149445
Sponsor
Saniona
Status
Completed
Last Update Posted
Feb 26, 2024Actual
Enrollment
18Actual
Phase
Phase 2
Conditions
Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Interventions
Tesofensine/Metoprolol
Placebos
Countries
Czechia
Hungary
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03149445
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
TM002
Secondary IDs
Not provided
Brief Title
Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Multi-Center Safety and Efficacy Study of Co-Administration of Tesofensine/Metoprolol for 12 Weeks in Adult and Adolescent Patients With Prader-Willi Syndrome (PWS), Followed by Two Open Label 12 Weeks Extension Periods for Adolescent Patients
Acronym
2016-003694-18
Organization
SanionaINDUSTRY
Status Module
Record Verification Date
Feb 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 30, 2017Actual
Primary Completion Date
Jul 22, 2019Actual
Completion Date
Jul 22, 2019Actual
First Submitted Date
Apr 3, 2017
First Submission Date that Met QC Criteria
May 10, 2017
First Posted Date
May 11, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jul 7, 2022
Results First Submitted that Met QC Criteria
Feb 23, 2024
Results First Posted Date
Feb 26, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 23, 2024
Last Update Posted Date
Feb 26, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
SanionaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.
Detailed Description
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study. Study medication will be administered for 91 days. The study will be conducted in two steps:
Step 1 - 9 adult subjects with PWS was treated.
Sponsor review - following the completion of the treatment of the adult subjects, unblinded efficacy, safety, Pharmacokinetic (PK) data as well as all data from the study in subjects with type 2 diabetes (TM001) will be reviewed by sponsor and an interim analysis will be done. Following competent authority positive opinion regarding the interim analysis and unblinded data the study will proceed to:
Step 2 - 9 adolescent subjects with PWS was treated.
OLE (Open Label Extension) I - Participation in a 12-week OLE I was offered to subjects who completed Step 2. 8 subjects entered OLE I.
OLE (Open Label Extension) II - Participation in a 12-week OLE II was offered to subjects who completed OLE I. 6 subjects continued to OLE II.
Conditions Module
Conditions
Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
18Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tesofensine/Metoprolol
Experimental
Tesofensine + metoprolol administered once a day, in the morning with a meal
Drug: Tesofensine/Metoprolol
Tesofensine/Metoprolol placebo
Placebo Comparator
Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal
Drug: Placebos
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tesofensine/Metoprolol
Drug
Study medication will be administered for 91 days.
Tesofensine/Metoprolol
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to End of Treatment in Mean Body Weight
Percent change from baseline to end of treatment in mean body weight. LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline to End of Treatment in Mean Body Weight
Change from baseline to end of treatment in body weight [kg]. LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females with a confirmed genetic diagnosis of Prader-Willi syndrome
Age:
Step 1: Adults aged 18-30
Step 2: Adolescents aged 12-17
Body Mass Index (BMI):
Step 1: Adults with ≥25 kg/m2
Step 2: Children with a BMI >85th percentile for the same age and sex
Normal Blood Pressure (BP) or well managed hypertension (only if dose of BP medication(s) has been stable for >2 months)
Normal lipid profile or well managed dyslipidemia (only if dose of lipid-lowering medication(s) has been stable for >2 months)
Growth hormone is allowed; but patient must be on stable dose of growth hormone >2 months
Type 2 diabetes is allowed, but the following criteria must be met:
HbA1c <10.0 % not being managed with insulin within the past 3 months
Patients taking GLP-1 analogues (e.g. exenatide, liraglutide) must have been on stable dose for >3 months
Fasting plasma glucose <11.0 mmol/l
Exclusion Criteria:
BP:
Step 1: Adults with >140/90
Step 2: Adolescents with ≥95th percentile for gender, age, and height
Heart Rate (HR) ≥ 90, <50 bpm
Hypersensitivity to tesofensine/metoprolol
Type 1 diabetes
Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
Previous myocardial infarction or stroke
Diagnosis of schizophrenia, bipolar disorder, personality disorder or other DSM-III disorders, or any other psychiatric condition, which in the investigator's opinion will interfere significantly with study compliance
History of major depressive disorder or suicidality
Any clinically significant cardiac arrhythmia
Treatment with calcium channel blockers and beta blockers
Concomitant use of monoaminooxidase inhibitors
Bulimia or anorexia nervosa
Any agent used for weight loss in the past 3 months
Untreated hypo- or hyperthyroidism
Clinically significant liver (>3x ULN (Upper Limit of Normal range)) and/or kidney impairment
More than 5% weight loss within the last 3 months
Any other clinically meaningful condition, in the opinion of the investigator, which would make participation potentially unsafe
Contraindications to administration of metoprolol per current Summary of Product Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
30 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Kim Krogsgaard, MD, DMSc
Saniona
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Motol University Hospital
Prague
150 06
Czechia
Semmelweis University
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
FG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
FG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
FG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
FG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
FG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
FG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
FG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Periods
Title
Milestones
Reasons Not Completed
Double-blind (DB) Step 1
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Double-blind (DB) Step 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG003
Open Label Extension (OLE) I
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open Label Extension (OLE) II
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
BG001
Placebo (Adult)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
It is the same adolescent subjects participating in DB Step 2, OLE I and OLE II.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline to End of Treatment in Mean Body Weight
Percent change from baseline to end of treatment in mean body weight. LOCF.
5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
Percent (%) change in mean body weight
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Adverse Events Module
Frequency Threshold
0
Time Frame
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
Study medication will be administered for 91 days.
Tesofensine/Metoprolol placebo
Placebo
Change from baseline to end of treatment in HQ-CT score. LOCF. HQ-CT score was based upon a questionnaire with 9 items, each of them yielding a score between 0 and 4 resulting in a maximum HQ-CT score of 36. Change in HQ-CT answers (by question and in total) calculated as score at visit 2, 5, 9 or 14 minus score at screening visit 1 was analysed and presented using standard descriptive statistics (mean, median, standard deviation, minimum and maximum value). A decrease in total score indicates an improvement in hyperphagia. If less than three questions were answered by a subject, the missing answers were imputed by the mean score of all other available answers. In case of more than three missing answers, the total score was not calculated. For further information please refer to protocol appendix section 17.1.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
Steady state concentrations of tesofensine and metoprolol as measured by trough values. Observed values.
DB Step 1: Day 29; DB Step 2: Day 29; OLE I: Day 120; OLE II: Day 210
Change From Baseline to End of Treatment in Fat- and Fat Free Mass (%) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in fat- and fat free mass (%) by dual X-ray absorptiometry (DEXA). Observed values.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Bone Mineral Density (BMD) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in BMD by dual X-ray absorptiometry (DEXA). Observed values.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Bone Mineral Content (BMC) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in BMC by dual X-ray absorptiometry (DEXA). Observed values.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Heart Rate (HR)
Change from baseline to end of treatment in HR (bpm). LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline to end of treatment in SBP (mmHg) and DBP (mmHg). LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Total Number of Adverse Events
Total number of Adverse Events
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in PR Interval
Change from baseline to end of treatment in PR interval. Observed values.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
Change from baseline to end of treatment in ECG parameters - QRS duration, QT interval, QTcF and QTcB
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in HbA1c
Change from baseline to end of treatment in HbA1c (%). LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Insulin
Change from baseline to end of treatment in insulin (mIU/L). LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
Change from baseline to end of treatment in fasting pl. glucose (mmol/L), triglycerides (mmol/L), LDL and HDL cholesterol (mmol/L). LOCF.
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Number of subjects with Adverse Events and Serious Adverse Events
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
Budapest
H-1094
Hungary
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
4 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0044 subjects
FG0054 subjects
FG0060 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG0071 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0063 subjects
FG0071 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
BG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
BG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
BG004
Total
Total of all reporting groups
6
BG0013
BG0025
BG0034
BG00418
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0025
BG0034
BG0049
Between 18 and 65 years
BG0006
BG0013
BG0020
BG0030
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG0022
BG0032
BG00410
Male
BG0002
BG0011
BG0023
BG0032
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0006
BG0013
BG0025
BG0034
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
Hungary
Title
Measurements
BG0003
BG0012
BG0023
BG0032
BG00410
Czechia
Title
Measurements
BG0003
BG0011
BG0022
BG003
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG0034
OG0044
OG0054
OG0064
OG0071
Title
Denominators
Categories
Title
Measurements
OG000-4.09± 3.73
OG001-0.38± 2.05
OG0023.56± 2.73
OG0033.00± 2.35
OG0045.79± 2.08
OG0050.33± 3.26
OG006-1.20± 3.80
OG007-5.51± NAOnly 1 subject was included in this group.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.1045
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
-5.4
2-Sided
95
-12.3
1.5
Superiority
OG002
OG003
ANCOVA
0.7422
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
0.7
2-Sided
95
-4.0
5.3
Superiority
OG004
OG005
ANCOVA
0.0460
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
5.6
2-Sided
95
0.1
11.0
Superiority
OG006
OG007
ANCOVA
0.3847
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
4.3
2-Sided
95
-9.2
17.8
Superiority
Secondary
Change From Baseline to End of Treatment in Mean Body Weight
Change from baseline to end of treatment in body weight [kg]. LOCF.
5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
kg
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.15± 4.82
OG001-0.77± 3.23
OG0023.10± 2.85
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.1326
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
-6.2
2-Sided
95
-14.9
2.5
Superiority
OG002
OG003
ANCOVA
Secondary
Change From Baseline to End of Treatment in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
Change from baseline to end of treatment in HQ-CT score. LOCF. HQ-CT score was based upon a questionnaire with 9 items, each of them yielding a score between 0 and 4 resulting in a maximum HQ-CT score of 36. Change in HQ-CT answers (by question and in total) calculated as score at visit 2, 5, 9 or 14 minus score at screening visit 1 was analysed and presented using standard descriptive statistics (mean, median, standard deviation, minimum and maximum value). A decrease in total score indicates an improvement in hyperphagia. If less than three questions were answered by a subject, the missing answers were imputed by the mean score of all other available answers. In case of more than three missing answers, the total score was not calculated. For further information please refer to protocol appendix section 17.1.
Data only available for 2 patients in Step I placebo arm. 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
score on a scale
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG000-8.50± 9.25
OG001-4.00± 7.07
OG002-3.30± 6.82
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.0058
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
-8.1
2-Sided
95
-12.5
-3.6
Superiority
OG002
OG003
ANCOVA
Secondary
Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
Steady state concentrations of tesofensine and metoprolol as measured by trough values. Observed values.
No data available for placebo arm in Step I and Step 2. Data only available for 3 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/L
DB Step 1: Day 29; DB Step 2: Day 29; OLE I: Day 120; OLE II: Day 210
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0010
OG0025
OG003
Title
Denominators
Categories
Tesofensine
Title
Measurements
OG00016.29± 49.8
OG0023.34± 32.2
OG0044.14± 17.3
OG005
Secondary
Change From Baseline to End of Treatment in Fat- and Fat Free Mass (%) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in fat- and fat free mass (%) by dual X-ray absorptiometry (DEXA). Observed values.
Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg).
Data only available for 2 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Posted
Mean
Standard Deviation
Percent (%)
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0003
OG0010
OG0023
OG003
Title
Denominators
Categories
Fat mass
Title
Measurements
OG000-1.27± 1.07
OG002-0.13± 0.25
OG003-0.50± 0.85
OG004
Secondary
Change From Baseline to End of Treatment in Bone Mineral Density (BMD) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in BMD by dual X-ray absorptiometry (DEXA). Observed values.
Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg).
Data only available for 2 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Posted
Mean
Standard Deviation
g/cm^2
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0003
OG0010
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.002± 0.0017
OG0020.019± 0.009
OG0030.035± 0.008
OG004
Secondary
Change From Baseline to End of Treatment in Bone Mineral Content (BMC) by Dual X-ray Absorptiometry (DEXA)
Change from baseline to end of treatment in BMC by dual X-ray absorptiometry (DEXA). Observed values.
Data only available for 3 patients in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 3 patients in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 3 patients in OLE I (Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg).
Data only available for 2 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). Data only available for 2 patients in OLE II (Tesomet 0.25/25 mg).
Posted
Mean
Standard Deviation
gram
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0003
OG0010
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.5± 63.8
OG00274.77± 22.46
OG00335.53± 55.37
OG004
Secondary
Change From Baseline to End of Treatment in Heart Rate (HR)
Change from baseline to end of treatment in HR (bpm). LOCF.
5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
bpm
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.22± 4.26
OG0017.89± 7.88
OG0025.87± 11.01
OG003
Secondary
Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline to end of treatment in SBP (mmHg) and DBP (mmHg). LOCF.
5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
mmHg
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG003
Title
Denominators
Categories
Change in SBP
Title
Measurements
OG000-2.72± 9.96
OG0010.11± 15.22
OG002-0.13± 15.79
OG003
Secondary
Total Number of Adverse Events
Total number of Adverse Events
Posted
Number
Total number of adverse events
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG00023
OG00110
OG00219
OG003
Secondary
Change From Baseline to End of Treatment in PR Interval
Change from baseline to end of treatment in PR interval. Observed values.
Data only available for 1 patient in Step I (Tesomet 0.50/50 mg). Data not available for the Placebo (adult) arm. Data only available for 1 patient in Step 2 (Tesomet 0.125/25 mg (DB)). Data only available for 2 patients in Step 2 (Placebo (adolescent)). Data only available for 1 patient in OLE I (Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg).
Data only available for 1 patient in OLE I (Placebo -> Tesomet 0.125/25 mg). Data not available for OLE II (Tesomet 0.25/25 mg).
Posted
Mean
Standard Deviation
ms
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG000-20.0± NAOnly 1 subject was included in this group.
OG0020.0± NAOnly 1 subject was included in this group.
OG00320.0± 0.0
Secondary
Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
Change from baseline to end of treatment in ECG parameters - QRS duration, QT interval, QTcF and QTcB
Posted
Mean
Standard Deviation
ms
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0002
OG0012
OG0024
OG003
Title
Denominators
Categories
QRS duration
Title
Measurements
OG000-4.0± 8.5
OG0014.0± 0.0
OG0022.0± 2.3
OG003
Secondary
Change From Baseline to End of Treatment in HbA1c
Change from baseline to end of treatment in HbA1c (%). LOCF.
Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
Percentage of HbA1c
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.11± 0.13
OG0010.15± 0.21
OG0020.06± 0.05
OG003
Secondary
Change From Baseline to End of Treatment in Insulin
Change from baseline to end of treatment in insulin (mIU/L). LOCF.
Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
mIU/L
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.67± 10.93
OG0011.50± 10.61
OG0021.95± 13.85
OG003
Secondary
Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
Change from baseline to end of treatment in fasting pl. glucose (mmol/L), triglycerides (mmol/L), LDL and HDL cholesterol (mmol/L). LOCF.
Data only available for 2 patients in the Placebo (adult) arm. Data only available for 3 patients in OLE I (Placebo -> Tesomet 0.125/25 mg). 5 patients started on Tesomet 0.25/25mg in OLE II however 1 subject discontinued early without any further observations and data are therefore only available from 4 subjects.
Posted
Mean
Standard Deviation
mmol/L
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0012
OG0025
OG003
Title
Denominators
Categories
Fasting pl. glucose
Title
Measurements
OG0000.27± 0.59
OG0010.30± 0.14
OG002-0.20± 0.58
OG003
Secondary
Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Number of subjects with Adverse Events and Serious Adverse Events
Posted
Count of Participants
Participants
DB Step 1: Day 1 to Day 91; DB Step 2: Day 1 to Day 91; OLE I: Day 91 to Day 181; OLE II: Day 181 to Day 271
ID
Title
Description
OG000
Tesomet 0.50/50 mg
Subjects (adults) were randomized to receive co-administration of 0.5 mg tesofensine/50 mg metoprolol (active medication Tesomet) once daily for 91 days (+2 days after the final assessments with halfdose of metoprolol) during Step 1.
OG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
OG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
OG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
OG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
OG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
OG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
Units
Counts
Participants
OG0006
OG0013
OG0025
OG003
Title
Denominators
Categories
Subjects with at least one AE
Title
Measurements
OG0006
OG0013
OG0025
OG003
0
6
3
6
6
6
EG001
Placebo (Adult)
Subjects (adults) were randomized to receive placebo once daily for 91 days during Step 1.
0
3
0
3
3
3
EG002
Tesomet 0.125/25 mg (DB)
Subjects (adolescents) were randomized to receive co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 91 days: +2days after the final assessments with halfdose.
0
5
0
5
5
5
EG003
Placebo (Adolescent)
Subjects (adolescents) were randomized to receive placebo once daily for 91 days.
0
4
0
4
3
4
EG004
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
0
4
0
4
4
4
EG005
Placebo -> Tesomet 0.125/25 mg
Participation in a 12-week OLE I was offered to patients who completed Step 2. Patients were receiving co-administration of 0.125 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE I.
0
4
0
4
4
4
EG006
Tesomet 0.25/25 mg
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.25 mg tesofensine/25 mg metoprolol (active medication Tesomet) once daily for 12 weeks during OLE II.
0
5
2
5
5
5
EG007
Tesomet 0.125/25 mg (OLE II)
Participation in a 12 week OLE II was offered to all eligible patients of OLE I. Patients were receiving coadministration of 0.125 mg tesofensine/25 mg metoprolol (active medication) once daily for 12 weeks.
0
1
0
1
1
1
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Hallucination
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Abnormal behaviour
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected5 at risk
EG0070 events0 affected1 at risk
Retroperitoneal abscess
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Arthropod sting
Injury, poisoning and procedural complications
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected1 at risk
Headache
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0002 events1 affected6 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Dizziness
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Somnolence
Nervous system disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Fatigue
General disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Feeling cold
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Pyrexia
General disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events2 affected3 at risk
EG0022 events2 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected5 at risk
EG0071 events1 affected1 at risk
Nausea
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Insomnia
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0003 events3 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected5 at risk
EG0031 events1 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected1 at risk
Affect lability
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Aggression
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected1 at risk
Delusion
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Illusion
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Depression
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Restlessness
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Abnormal behaviour
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected4 at risk
EG0062 events2 affected5 at risk
EG0070 events0 affected1 at risk
Mood swings
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Dermatillomania
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Hallucination
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Panic attack
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Anxiety
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Depressed mood
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Mood altered
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Negativism
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Sleep disorder
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Nervousness
Psychiatric disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0071 events1 affected1 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0032 events2 affected4 at risk
EG0041 events1 affected4 at risk
EG0052 events2 affected4 at risk
EG0063 events3 affected5 at risk
EG0070 events0 affected1 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
Bronchitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Gastroenteritis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Gastroenteritis viral
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Nasopharyngitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0032 events1 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Otitis externa
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Rhinitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Cystitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Conjunctivitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Pharyngitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
EG0070 events0 affected1 at risk
Tonsillitis
Infections and infestations
MedDRA (23.0)
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
EG0070 events0 affected1 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D009930
Organic Chemicals
D020005
Propanols
D000588
Amines
9
0
8
0
0
0
18
0
0
2
BG0048
4
OG0044
OG0054
OG0064
OG0071
2.25
± 1.71
OG0044.75± 2.41
OG0050.45± 2.82
OG006-0.90± 3.20
OG007-3.50± NAOnly 1 subject was included in this group.
0.5148
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
1.2
2-Sided
95
-2.9
5.3
Superiority
OG004
OG005
ANCOVA
0.0605
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
4.5
2-Sided
95
-0.3
9.4
Superiority
OG006
OG007
ANCOVA
0.5198
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
2.6
2-Sided
95
-8.8
14.0
Superiority
4
OG0044
OG0054
OG0064
OG0071
-6.75
± 3.69
OG0041.25± 5.68
OG005-1.75± 1.50
OG006-1.00± 2.00
OG007-2.00± NAOnly 1 subject was included in this group.
0.5142
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
2.1
2-Sided
95
-5.3
9.5
Superiority
OG004
OG005
ANCOVA
0.3794
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
3.1
2-Sided
95
-5.1
11.3
Superiority
OG006
OG007
ANCOVA
0.6850
P-value from an ANCOVA with treatment as factor and baseline as covariate
LS Mean Difference
1.0
2-Sided
95
-6.1
8.1
Superiority
0
OG0044
OG0053
OG0064
OG0071
5.06
± 18.0
OG0064.13± 137.5
OG0076.43± NAOnly 1 subject was included in this group.
Teso. metab.
Title
Measurements
OG0002.97± 52.6
OG0020.79± 17.1
OG0041.45± 23.3
OG0051.00± 41.9
OG0061.56± 49.1
OG0071.98± NAOnly 1 subject was included in this group.
Metoprolol
Title
Measurements
OG0001.61± 903.7
OG0021.97± 285.5
OG0042.81± 119.0
OG0053.32± 32.0
OG0061.76± 242.5
OG00714.50± NAOnly 1 subject was included in this group.
2
OG0043
OG0052
OG0062
OG0071
1.20
± 1.74
OG005-0.05± 0.21
OG006-1.70± 0.1
OG007-1.50± NAOnly 1 subject was included in this group.
Fat free mass
Title
Measurements
OG0001.19± 1.11
OG0020.137± 0.217
OG003-2.080± 4.511
OG0040.053± 2.559
OG0054.290± 3.974
OG0060.000± 0.1
OG0071.470± NAOnly 1 subject was included in this group.
2
OG0043
OG0052
OG0062
OG0071
-0.006
± 0.008
OG005-0.007± 0.009
OG0060.023± 0.0
OG0070.009± NAOnly 1 subject was included in this group.
2
OG0043
OG0052
OG0062
OG0071
-1.12
± 17.86
OG0055.69± 66.33
OG00622.51± 46.6
OG007-21.90± NAOnly 1 subject was included in this group.
4
OG0044
OG0054
OG0064
OG0071
2.75
± 8.96
OG0042.42± 15.14
OG0050.33± 8.65
OG006-9.50± 10.86
OG007-5.67± NAOnly 1 subject was included in this group.
4
OG0044
OG0054
OG0064
OG0071
-5.00
± 9.26
OG0045.67± 11.30
OG0058.08± 6.45
OG006-5.33± 2.60
OG007-9.67± NAOnly 1 subject was included in this group.
Change in DBP
Title
Measurements
OG0000.94± 10.72
OG001-8.89± 8.00
OG002-1.07± 7.06
OG0030.33± 2.54
OG0042.92± 10.22
OG0054.00± 5.40
OG006-6.42± 3.95
OG0071.33± NAOnly 1 subject was included in this group.
4
OG0044
OG0054
OG0065
OG0071
9
OG00411
OG00512
OG00614
OG0075
2
OG0041
OG0051
OG0060
OG0071
OG0040.0± NAOnly 1 subject was included in this group.
OG005-20.0± NAOnly 1 subject was included in this group.
OG00710.0± NAOnly 1 subject was included in this group.
4
OG0044
OG0053
OG0062
OG0071
2.0
± 8.5
OG004-1.5± 3.0
OG0050.7± 5.0
OG006-4.0± 5.7
OG0070.0± NAOnly 1 subject was included in this group.
QT interval
Title
Measurements
OG000-7.0± 18.4
OG00119.0± 9.9
OG002-5.5± 27.2
OG0035.5± 27.2
OG004-5.0± 19.2
OG005-13.3± 16.2
OG0067.0± 7.1
OG007-20.0± NAOnly 1 subject was included in this group.
QTcF
Title
Measurements
OG000-12.9± 4.4
OG00112.8± 19.8
OG0020.1± 24.4
OG00311.0± 20.4
OG004-3.7± 14.5
OG005-10.3± 29.3
OG00617.1± 4.5
OG007-2.9± NAOnly 1 subject was included in this group.
QTcB
Title
Measurements
OG000-16.0± 2.8
OG0019.0± 25.5
OG0023.5± 31.8
OG00313.9± 21.4
OG004-2.6± 22.8
OG005-8.2± 37.3
OG00623.0± 2.9
OG0078.2± NAOnly 1 subject was included in this group.
4
OG0044
OG0053
OG0064
OG0071
0.15
± 0.24
OG0040.12± 0.26
OG0050.10± 0.17
OG0060.00± 0.12
OG0070.00± NAOnly 1 subject was included in this group.
4
OG0044
OG0053
OG0064
OG0071
-10.32
± 17.20
OG00413.14± 22.15
OG0054.93± 5.25
OG006-1.35± 24.56
OG007-5.90± NAOnly 1 subject was included in this group.
4
OG0044
OG0053
OG0064
OG0071
-0.30
± 0.29
OG0041.07± 1.19
OG0050.37± 0.31
OG0060.60± 0.35
OG007-0.40± NAOnly 1 subject was included in this group.
Triglycerides
Title
Measurements
OG000-0.07± 0.29
OG001-0.02± 0.06
OG0020.56± 1.32
OG003-1.33± 1.54
OG004-0.54± 1.23
OG0050.38± 0.14
OG006-0.13± 0.26
OG0070.13± NAOnly 1 subject was included in this group.
LDL cholesterol
Title
Measurements
OG000-0.16± 0.44
OG001-0.12± 0.32
OG0020.16± 0.21
OG003-0.32± 0.99
OG004-0.02± 0.43
OG005-0.01± 0.43
OG0060.10± 0.32
OG007-0.25± NAOnly 1 subject was included in this group.
HDL cholesterol
Title
Measurements
OG000-0.10± 0.20
OG001-0.17± 0.01
OG002-0.03± 0.18
OG003-0.03± 0.17
OG0040.16± 0.22
OG0050.22± 0.11
OG006-0.05± 0.05
OG007-0.14± NAOnly 1 subject was included in this group.