Confirmed Genetic Diagnosis of Prader-Willi SyndromePhase 22016-003694-18NCT03149445

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

A Phase 2 study testing Tesofensine/Metoprolol in people with Confirmed Genetic Diagnosis of Prader-Willi Syndrome, run by Saniona at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 12 to 30 years
Conditions the study is for: Confirmed Genetic Diagnosis of Prader-Willi Syndrome
What is being tested?: Tesofensine/Metoprolol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 2 sitesin 2 countries
Study dates: 30 Mar 2017to 22 Jul 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 30 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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

Show all 20Show fewer

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Czechia1 site

Motol University Hospital
Prague, 150 06

Other trials in Czechia

Hungary1 site

Semmelweis University
Budapest, H-1094

Other trials in Hungary

About this study

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

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: Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Being tested: Tesofensine/Metoprolol, Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tesofensine/MetoprololDrug
Also called Tesofensine, Metoprolol
Study medication will be administered for 91 days.
PlacebosDrug
Also called Placebo
Study medication will be administered for 91 days.

Study groups in NCT03149445
Study group	Role	What they receive
Tesofensine/Metoprolol	Experimental	Tesofensine + metoprolol administered once a day, in the morning with a meal Receives: Drug: Tesofensine/Metoprolol
Tesofensine/Metoprolol placebo	Placebo comparator	Placebo tablets matching tesofensine + metoprolol administered once a day, in the morning with meal Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (15)

Change From Baseline to End of Treatment in Mean Body Weight
Change from baseline to end of treatment in body weight [kg]. LOCF.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Mar 201722 Jul 2019

First posted11 May 2017
Study start30 Mar 2017
Primary completion22 Jul 2019
Study completion22 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Confirmed Genetic Diagnosis of Prader-Willi SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03149445
Sponsor's protocol ID: TM002
Acronym: 2016-003694-18
Status last verified: Feb 2024
First submitted: 3 Apr 2017
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03149445
Acronym / sponsor ID: 2016-003694-18 / TM002
Conditions: Confirmed Genetic Diagnosis of Prader-Willi Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: SanionaIndustry (pharma, biotech, devices)
Study start: 30 Mar 2017 (actual)
Primary completion: 22 Jul 2019 (actual)
Study completion: 22 Jul 2019 (actual)
First posted: 11 May 2017 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study.

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

Who may qualify

Ages: 12 to 30 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (14 listed)

Males and females with a confirmed genetic diagnosis of Prader-Willi syndrome
Age:
Body Mass Index (BMI):
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)

Key exclusion criteria (20 listed)

BP:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tesofensine/MetoprololAlso: Tesofensine, MetoprololStudy medication will be administered for 91 days.	Drug	Tesofensine/Metoprolol
PlacebosAlso: PlaceboStudy medication will be administered for 91 days.	Drug	Tesofensine/Metoprolol placebo

Primary outcome

Percent Change From Baseline to End of Treatment in Mean Body Weight
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
Percent change from baseline to end of treatment in mean body weight. LOCF.

15 secondary outcomes

Change From Baseline to End of Treatment in Mean Body Weight
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
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
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)
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)
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)
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)
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)
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
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
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
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
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
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
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)
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 and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tesomet 0.50/50 mg	6	2
Placebo (Adult)	3	2
Tesomet 0.125/25 mg (DB)	0	0
Placebo (Adolescent)	0	0
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg	0	0
Placebo -> Tesomet 0.125/25 mg	0	0
Tesomet 0.25/25 mg	0	0
Tesomet 0.125/25 mg (OLE II)	0	0

Primary outcome: Percent Change From Baseline to End of Treatment in Mean Body Weight

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. Mean (Standard Deviation). Unit: Percent (%) change in mean body weight

Measure	Tesomet 0.50/50 mg n = 6	Placebo (Adult) n = 3	Tesomet 0.125/25 mg (DB) n = 5	Placebo (Adolescent) n = 4	Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg n = 4	Placebo -> Tesomet 0.125/25 mg n = 4	Tesomet 0.25/25 mg n = 4	Tesomet 0.125/25 mg (OLE II) n = 1
Value	-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)

Tesomet 0.50/50 mg vs Placebo (Adult): LS Mean Difference: -5.4 (95% CI -12.3 to 1.5), p = 0.1045, ANCOVA
Tesomet 0.125/25 mg (DB) vs Placebo (Adolescent): LS Mean Difference: 0.7 (95% CI -4.0 to 5.3), p = 0.7422, ANCOVA
Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg vs Placebo -> Tesomet 0.125/25 mg: LS Mean Difference: 5.6 (95% CI 0.1 to 11.0), p = 0.0460, ANCOVA

Population analysed: 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.

15 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 0% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kim Krogsgaard, MD, DMSc study director

Saniona

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tesofensine/Metoprolol in people with Confirmed Genetic Diagnosis of Prader-Willi Syndrome, run by Saniona at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Czechia, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline to End of Treatment in Mean Body Weight (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03149445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.