CompletedNCT031494452016-003694-18Updated Feb 26, 2024Results posted

Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

A Phase 2 interventional study of Tesofensine/Metoprolol and Placebos in Confirmed Genetic Diagnosis of Prader-Willi Syndrome, sponsored by Saniona. Completed at 2 sites in 2 countries. Open to participants aged 12 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-02-26.

Sponsored by Saniona · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 12 Years to 30 Years
Sex: All

Study summary

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.

Read the 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 studied

Confirmed Genetic Diagnosis of Prader-Willi Syndrome

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In context

Prader-Willi Syndrome

138 studies on the registry are indexed under Prader-Willi Syndrome; 24 are open to participants now.

This study's enrollment of 18 is below the median of 30 across 96 interventional studies indexed under Prader-Willi Syndrome.

Browse Prader-Willi Syndrome studies →

Lead sponsor

Saniona is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 30 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and females with a confirmed genetic diagnosis of Prader-Willi syndrome
Age:
1. Step 1: Adults aged 18-30
2. Step 2: Adolescents aged 12-17
Body Mass Index (BMI):
1. Step 1: Adults with ≥25 kg/m2
2. 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:
1. HbA1c \<10.0 % not being managed with insulin within the past 3 months
2. Patients taking GLP-1 analogues (e.g. exenatide, liraglutide) must have been on stable dose for >3 months
3. Fasting plasma glucose \<11.0 mmol/l

Exclusion criteria

Exclusion Criteria:

BP:
1. Step 1: Adults with >140/90
2. 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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 18 participants (actual)

Study arms

Experimental
Tesofensine/Metoprolol
Tesofensine + metoprolol administered once a day, in the morning with a meal
Drug: Tesofensine/Metoprolol
Placebo comparator
Tesofensine/Metoprolol placebo
Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal
Drug: Placebos

Interventions

DrugTesofensine/Metoprolol
Study medication will be administered for 91 days.
Also known as: Tesofensine, Metoprolol
DrugPlacebos
Study medication will be administered for 91 days.
Also known as: Placebo

What researchers measure

Primary outcomes

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.
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

Secondary outcomes

Change From Baseline to End of Treatment in Mean Body Weight
Change from baseline to end of treatment in body weight \[kg\]. LOCF.
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
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.
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
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.
Time frame: 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.
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
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.
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
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.
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
Change From Baseline to End of Treatment in Heart Rate (HR)
Change from baseline to end of treatment in HR (bpm). LOCF.
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
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.
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
Total Number of Adverse Events
Total number of Adverse Events
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
Change From Baseline to End of Treatment in PR Interval
Change from baseline to end of treatment in PR interval. Observed values.
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
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
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
Change From Baseline to End of Treatment in HbA1c
Change from baseline to end of treatment in HbA1c (%). LOCF.
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
Change From Baseline to End of Treatment in Insulin
Change from baseline to end of treatment in insulin (mIU/L). LOCF.
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
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.
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
Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Number of subjects with Adverse Events and Serious Adverse Events
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

Results

Posted Feb 26, 2024

Participant flow

Double-blind (DB) Step 1

Participant flow — Double-blind (DB) Step 1
Milestone	Tesomet 0.50/50 mg	Placebo (Adult)
Started	6	3
Completed	2	2
Not completed	4	1

Double-blind (DB) Step 2

Participant flow — Double-blind (DB) Step 2
Milestone	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)
Started	5	4
Completed	5	4
Not completed	0	0

Open Label Extension (OLE) I

Participant flow — Open Label Extension (OLE) I
Milestone	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg
Started	4	4
Completed	4	3
Not completed	0	1

Open Label Extension (OLE) II

Participant flow — Open Label Extension (OLE) II
Milestone	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Started	5	1
Completed	3	1
Not completed	2	0

Outcome measures

PrimaryPercent Change From Baseline to End of Treatment in Mean Body Weight

Percent change from baseline to end of treatment in mean body weight. LOCF.

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
Reported as:: Mean · Percent (%) change in mean body weight

Percent Change From Baseline to End of Treatment in Mean Body Weight
Percent (%) change in mean body weight	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Percent Change From Baseline to End of Treatment in Mean Body Weight	-4.09 ± 3.73	-0.38 ± 2.05	3.56 ± 2.73	3.00 ± 2.35	5.79 ± 2.08	0.33 ± 3.26	-1.20 ± 3.80	-5.51 ± NA

Statistical analysis

Tesomet 0.50/50 mg vs Placebo (Adult) · ANCOVA · p = 0.1045 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: -5.4 · 95% CI -12.3 to 1.5
Tesomet 0.125/25 mg (DB) vs Placebo (Adolescent) · ANCOVA · p = 0.7422 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 0.7 · 95% CI -4.0 to 5.3
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg vs Placebo -> Tesomet 0.125/25 mg · ANCOVA · p = 0.0460 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 5.6 · 95% CI 0.1 to 11.0
Tesomet 0.25/25 mg vs Tesomet 0.125/25 mg (OLE II) · ANCOVA · p = 0.3847 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 4.3 · 95% CI -9.2 to 17.8

SecondaryChange From Baseline to End of Treatment in Mean Body Weight

Change from baseline to end of treatment in body weight \[kg\]. LOCF.

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
Reported as:: Mean · kg

Change From Baseline to End of Treatment in Mean Body Weight
kg	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Mean Body Weight	-4.15 ± 4.82	-0.77 ± 3.23	3.10 ± 2.85	2.25 ± 1.71	4.75 ± 2.41	0.45 ± 2.82	-0.90 ± 3.20	-3.50 ± NA

Statistical analysis

Tesomet 0.50/50 mg vs Placebo (Adult) · ANCOVA · p = 0.1326 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: -6.2 · 95% CI -14.9 to 2.5
Tesomet 0.125/25 mg (DB) vs Placebo (Adolescent) · ANCOVA · p = 0.5148 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 1.2 · 95% CI -2.9 to 5.3
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg vs Placebo -> Tesomet 0.125/25 mg · ANCOVA · p = 0.0605 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 4.5 · 95% CI -0.3 to 9.4
Tesomet 0.25/25 mg vs Tesomet 0.125/25 mg (OLE II) · ANCOVA · p = 0.5198 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 2.6 · 95% CI -8.8 to 14.0

SecondaryChange 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.

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
Reported as:: Mean · score on a scale

Change From Baseline to End of Treatment in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score
score on a scale	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score	-8.50 ± 9.25	-4.00 ± 7.07	-3.30 ± 6.82	-6.75 ± 3.69	1.25 ± 5.68	-1.75 ± 1.50	-1.00 ± 2.00	-2.00 ± NA

Statistical analysis

Tesomet 0.50/50 mg vs Placebo (Adult) · ANCOVA · p = 0.0058 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: -8.1 · 95% CI -12.5 to -3.6
Tesomet 0.125/25 mg (DB) vs Placebo (Adolescent) · ANCOVA · p = 0.5142 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 2.1 · 95% CI -5.3 to 9.5
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg vs Placebo -> Tesomet 0.125/25 mg · ANCOVA · p = 0.3794 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 3.1 · 95% CI -5.1 to 11.3
Tesomet 0.25/25 mg vs Tesomet 0.125/25 mg (OLE II) · ANCOVA · p = 0.6850 (P-value from an ANCOVA with treatment as factor and baseline as covariate) · Ls mean difference: 1.0 · 95% CI -6.1 to 8.1

SecondarySteady 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.

Time frame:: DB Step 1: Day 29; DB Step 2: Day 29; OLE I: Day 120; OLE II: Day 210
Reported as:: Geometric mean · μg/L

Steady State Concentrations of Tesofensine and Metoprolol as Measured by Trough Values
μg/L	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Tesofensine	16.29 ± 49.8	—	3.34 ± 32.2	—	4.14 ± 17.3	5.06 ± 18.0	4.13 ± 137.5	6.43 ± NA
Teso. metab.	2.97 ± 52.6	—	0.79 ± 17.1	—	1.45 ± 23.3	1.00 ± 41.9	1.56 ± 49.1	1.98 ± NA
Metoprolol	1.61 ± 903.7	—	1.97 ± 285.5	—	2.81 ± 119.0	3.32 ± 32.0	1.76 ± 242.5	14.50 ± NA

SecondaryChange 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.

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
Reported as:: Mean · Percent (%)

Change From Baseline to End of Treatment in Fat- and Fat Free Mass (%) by Dual X-ray Absorptiometry (DEXA)
Percent (%)	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Fat mass	-1.27 ± 1.07	—	-0.13 ± 0.25	-0.50 ± 0.85	1.20 ± 1.74	-0.05 ± 0.21	-1.70 ± 0.1	-1.50 ± NA
Fat free mass	1.19 ± 1.11	—	0.137 ± 0.217	-2.080 ± 4.511	0.053 ± 2.559	4.290 ± 3.974	0.000 ± 0.1	1.470 ± NA

SecondaryChange 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.

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
Reported as:: Mean · g/cm^2

Change From Baseline to End of Treatment in Bone Mineral Density (BMD) by Dual X-ray Absorptiometry (DEXA)
g/cm^2	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Bone Mineral Density (BMD) by Dual X-ray Absorptiometry (DEXA)	0.002 ± 0.0017	—	0.019 ± 0.009	0.035 ± 0.008	-0.006 ± 0.008	-0.007 ± 0.009	0.023 ± 0.0	0.009 ± NA

SecondaryChange 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.

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
Reported as:: Mean · gram

Change From Baseline to End of Treatment in Bone Mineral Content (BMC) by Dual X-ray Absorptiometry (DEXA)
gram	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Bone Mineral Content (BMC) by Dual X-ray Absorptiometry (DEXA)	9.5 ± 63.8	—	74.77 ± 22.46	35.53 ± 55.37	-1.12 ± 17.86	5.69 ± 66.33	22.51 ± 46.6	-21.90 ± NA

SecondaryChange From Baseline to End of Treatment in Heart Rate (HR)

Change from baseline to end of treatment in HR (bpm). LOCF.

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
Reported as:: Mean · bpm

Change From Baseline to End of Treatment in Heart Rate (HR)
bpm	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Heart Rate (HR)	8.22 ± 4.26	7.89 ± 7.88	5.87 ± 11.01	2.75 ± 8.96	2.42 ± 15.14	0.33 ± 8.65	-9.50 ± 10.86	-5.67 ± NA

SecondaryChange 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.

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
Reported as:: Mean · mmHg

Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
mmHg	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change in SBP	-2.72 ± 9.96	0.11 ± 15.22	-0.13 ± 15.79	-5.00 ± 9.26	5.67 ± 11.30	8.08 ± 6.45	-5.33 ± 2.60	-9.67 ± NA
Change in DBP	0.94 ± 10.72	-8.89 ± 8.00	-1.07 ± 7.06	0.33 ± 2.54	2.92 ± 10.22	4.00 ± 5.40	-6.42 ± 3.95	1.33 ± NA

SecondaryTotal Number of Adverse Events

Total number of Adverse Events

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
Reported as:: Number · Total number of adverse events

Total Number of Adverse Events
Total number of adverse events	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Total Number of Adverse Events	23	10	19	9	11	12	14	5

SecondaryChange From Baseline to End of Treatment in PR Interval

Change from baseline to end of treatment in PR interval. Observed values.

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
Reported as:: Mean · ms

Change From Baseline to End of Treatment in PR Interval
ms	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in PR Interval	-20.0 ± NA	—	0.0 ± NA	20.0 ± 0.0	0.0 ± NA	-20.0 ± NA	—	10.0 ± NA

SecondaryChange 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

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
Reported as:: Mean · ms

Change From Baseline to End of Treatment in Electrocardiogram (ECG) Parameters
ms	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
QRS duration	-4.0 ± 8.5	4.0 ± 0.0	2.0 ± 2.3	2.0 ± 8.5	-1.5 ± 3.0	0.7 ± 5.0	-4.0 ± 5.7	0.0 ± NA
QT interval	-7.0 ± 18.4	19.0 ± 9.9	-5.5 ± 27.2	5.5 ± 27.2	-5.0 ± 19.2	-13.3 ± 16.2	7.0 ± 7.1	-20.0 ± NA
QTcF	-12.9 ± 4.4	12.8 ± 19.8	0.1 ± 24.4	11.0 ± 20.4	-3.7 ± 14.5	-10.3 ± 29.3	17.1 ± 4.5	-2.9 ± NA
QTcB	-16.0 ± 2.8	9.0 ± 25.5	3.5 ± 31.8	13.9 ± 21.4	-2.6 ± 22.8	-8.2 ± 37.3	23.0 ± 2.9	8.2 ± NA

SecondaryChange From Baseline to End of Treatment in HbA1c

Change from baseline to end of treatment in HbA1c (%). LOCF.

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
Reported as:: Mean · Percentage of HbA1c

Change From Baseline to End of Treatment in HbA1c
Percentage of HbA1c	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in HbA1c	0.11 ± 0.13	0.15 ± 0.21	0.06 ± 0.05	0.15 ± 0.24	0.12 ± 0.26	0.10 ± 0.17	0.00 ± 0.12	0.00 ± NA

SecondaryChange From Baseline to End of Treatment in Insulin

Change from baseline to end of treatment in insulin (mIU/L). LOCF.

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
Reported as:: Mean · mIU/L

Change From Baseline to End of Treatment in Insulin
mIU/L	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Change From Baseline to End of Treatment in Insulin	2.67 ± 10.93	1.50 ± 10.61	1.95 ± 13.85	-10.32 ± 17.20	13.14 ± 22.15	4.93 ± 5.25	-1.35 ± 24.56	-5.90 ± NA

SecondaryChange 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.

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
Reported as:: Mean · mmol/L

Change From Baseline to End of Treatment in Fasting pl. Glucose, Triglycerides, Low-density Lipoprotein (LDL) and High-density Lipoprotein (HDL) Cholesterol
mmol/L	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Fasting pl. glucose	0.27 ± 0.59	0.30 ± 0.14	-0.20 ± 0.58	-0.30 ± 0.29	1.07 ± 1.19	0.37 ± 0.31	0.60 ± 0.35	-0.40 ± NA
Triglycerides	-0.07 ± 0.29	-0.02 ± 0.06	0.56 ± 1.32	-1.33 ± 1.54	-0.54 ± 1.23	0.38 ± 0.14	-0.13 ± 0.26	0.13 ± NA
LDL cholesterol	-0.16 ± 0.44	-0.12 ± 0.32	0.16 ± 0.21	-0.32 ± 0.99	-0.02 ± 0.43	-0.01 ± 0.43	0.10 ± 0.32	-0.25 ± NA
HDL cholesterol	-0.10 ± 0.20	-0.17 ± 0.01	-0.03 ± 0.18	-0.03 ± 0.17	0.16 ± 0.22	0.22 ± 0.11	-0.05 ± 0.05	-0.14 ± NA

SecondaryNumber of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)

Number of subjects with Adverse Events and Serious Adverse Events

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
Reported as:: Count of participants · Participants

Number of Subjects With Adverse Events (AE) and Serious Adverse Events (SAE)
Participants	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Subjects with at least one AE	6	3	5	3	4	4	5	1
Subjects with at least one SAE	3	0	0	0	0	0	2	0

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tesomet 0.50/50 mg	0/6 (0%)	3/6 (50%)	6/6 (100%)
Placebo (Adult)	0/3 (0%)	0/3 (0%)	3/3 (100%)
Tesomet 0.125/25 mg (DB)	0/5 (0%)	0/5 (0%)	5/5 (100%)
Placebo (Adolescent)	0/4 (0%)	0/4 (0%)	3/4 (75%)
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	0/4 (0%)	0/4 (0%)	4/4 (100%)
Placebo -> Tesomet 0.125/25 mg	0/4 (0%)	0/4 (0%)	4/4 (100%)
Tesomet 0.25/25 mg	0/5 (0%)	2/5 (40%)	5/5 (100%)
Tesomet 0.125/25 mg (OLE II)	0/1 (0%)	0/1 (0%)	1/1 (100%)

Most frequent serious events

Most frequent serious events
Event	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
Type 2 diabetes mellitusMetabolism and nutrition disorders	0/6	0/3	0/5	0/4	0/4	0/4	1/5	0/1
Retroperitoneal abscessInfections and infestations	0/6	0/3	0/5	0/4	0/4	0/4	1/5	0/1
AngerPsychiatric disorders	1/6	0/3	0/5	0/4	0/4	0/4	0/5	0/1
HallucinationPsychiatric disorders	1/6	0/3	0/5	0/4	0/4	0/4	0/5	0/1
Abnormal behaviourPsychiatric disorders	1/6	0/3	0/5	0/4	0/4	0/4	0/5	0/1

Most frequent other events

Showing 10 of 50

Most frequent other events
Event	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	Placebo -> Tesomet 0.125/25 mg	Tesomet 0.25/25 mg	Tesomet 0.125/25 mg (OLE II)
EpistaxisRespiratory, thoracic and mediastinal disorders	0/6	0/3	0/5	0/4	0/4	0/4	0/5	1/1
DiarrhoeaGastrointestinal disorders	0/6	2/3	2/5	0/4	0/4	1/4	1/5	1/1
InsomniaPsychiatric disorders	3/6	0/3	2/5	1/4	1/4	0/4	0/5	1/1
AggressionPsychiatric disorders	1/6	0/3	0/5	1/4	0/4	1/4	0/5	1/1
NervousnessPsychiatric disorders	0/6	0/3	0/5	0/4	0/4	0/4	0/5	1/1
OsteoporosisMusculoskeletal and connective tissue disorders	1/6	0/3	1/5	2/4	1/4	2/4	3/5	0/1
Abnormal behaviourPsychiatric disorders	0/6	0/3	0/5	0/4	2/4	0/4	2/5	0/1
HeadacheNervous system disorders	1/6	1/3	0/5	0/4	0/4	0/4	0/5	0/1
DizzinessNervous system disorders	0/6	1/3	0/5	0/4	0/4	0/4	0/5	0/1
SomnolenceNervous system disorders	0/6	1/3	0/5	0/4	0/4	0/4	0/5	0/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Total
<=18 years	0	0	5	4	9
Between 18 and 65 years	6	3	0	0	9
>=65 years	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Total
Female	4	2	2	2	10
Male	2	1	3	2	8

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Total
American Indian or Alaska Native	0	0	0	0	0
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	6	3	5	4	18
More than one race	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Tesomet 0.50/50 mg	Placebo (Adult)	Tesomet 0.125/25 mg (DB)	Placebo (Adolescent)	Total
Hungary	3	2	3	2	10
Czechia	3	1	2	2	8

Study locations

2 sites

Motol University Hospital
Prague, 150 06, Czechia
Semmelweis University
Budapest, H-1094, Hungary

References and documents

Study documents

Study protocol · Jan 31, 2019
Statistical analysis plan · Aug 10, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03149445
Lead sponsor: Saniona
Responsible party: Sponsor
First posted: May 11, 2017
Start date: Mar 30, 2017
Primary completion: Jul 22, 2019
Completion: Jul 22, 2019
Results posted: Feb 26, 2024
Last update: Feb 26, 2024

Study contacts

Kim Krogsgaard, MD, DMSc

study director · Saniona

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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