Prader-Willi SyndromePhase 2PWSNCT05198362
Study of Tesomet With Open-label Extension in Subjects With Prader-Willi Syndrome
A Phase 2 study testing Tesomet in people with Prader-Willi Syndrome, run by Saniona at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- Tesomet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2021to 9 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject and their legally authorized representative must be willing to provide informed consent
- Confirmed genetic diagnosis of PWS
- Body mass index (BMI) within the following range at Screening:
- Female and male subjects 18 to 65 years of age: 27 to 60 kg/m2; or
- Female and male subjects 13 to 17 years of age with BMI that is at least 85th percentile for age and sex;
- Female subjects must be of non-child-bearing potential
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- Documented stable body weight
- Moderate hyperphagia at Screening and at Baseline
- Participants must have a reliable and stable caregiver who should be able to spend an adequate amount of time with the participants to be able to address behaviors, activities and symptoms
- Male subjects who are sexually active must be surgically sterile
Who cannot join
- Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
- Sitting BP that meets the following criteria after 5 minutes of rest at Screening:
- Adult subjects with systolic BP >/=145 mmHg or <100 mmHg; or
- Adult subjects with diastolic BP >/=95 mmHg or <70 mmHg; or
- Adolescent subjects with a systolic or diastolic BP that is 95th percentile or greater for age and sex
- Type 1 diabetes mellitus
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- History of dementia (eg, Alzheimer's disease, Parkinson's disease)
- History of bulimia or anorexia nervosa
- History of major depressive disorder within 2 years prior to Screening, or any history of other severe psychiatric disorder (eg, schizophrenia, bipolar disorder), or symptoms of delusions, hallucinations, or mania/hypomania within 90 days prior to Screening, as described by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- Uncontrolled endocrine disorders (eg, Cushing syndrome, Addison's, hypothyroidism, hyperthyroidism)
- Medical condition or recent systemic infection that, in the opinion of the Investigator, could impact the safety of the subject
- Use of prohibited medications, including current use of SSRIs/SNRIs
Trial locations and contacts
1 site in 1 country.
United States1 site
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
About this study
Official title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
Read the detailed description
For the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. Following independent Data Monitoring Board review of subgroup safety data, and review and confirmation to proceed by FDA, enrollment of subjects <18 years of age will commence.
- Conditions
- Prader-Willi Syndrome
- Being tested
- Placebo, Tesomet
- Keywords
- hyperphagia
- Medical subject headings
- Prader-Willi Syndrome, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Inactive comparator
TesometDrug
Also called tesofensine, metoprolol
Fixed-dose combination
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Once-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated Tesomet dose from the double-blind period Receives: Other: Placebo; Drug: Tesomet |
| Tesomet Low Dose | Experimental | Once-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period Receives: Drug: Tesomet |
| Tesomet Medium Dose | Experimental | Once-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period Receives: Drug: Tesomet |
| Tesomet High Dose | Experimental | Once-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period Receives: Drug: Tesomet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperphagia
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score
Measured: Baseline to Week 16
Secondary outcomes (5)
Change in Body Weight
Percentage change in body weight
Measured: Baseline to Week 16
Hyperphagia Severity (Caregiver)
Change in caregiver rating of hyperphagia severity
Measured: Baseline to Week 16
Hyperphagia Change (Caregiver)
Proportion of caregiver responses for change in subject's hyperphagia
Measured: Week 16
PWS Severity (Clinician)
Change in clinician rating of the subject's PWS severity
Measured: Baseline to Week 16
Overall Status Change (Clinician)
Proportion of clinician responses for change in subject's overall clinical status
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start28 Dec 2021
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Why it stopped: Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saniona
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sophie Guillaume, MS, Study director, Saniona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198362
- Sponsor's protocol ID
- TM006
- Acronym
- PWS
- Status last verified
- Dec 2022
- First submitted
- 5 Jan 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Sponsor will consider requests from qualified researchers for access to TM006 study materials
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-blind, Randomized, Placebo-controlled, Multi-center, 16-week Dose Finding, Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT05198362
- Acronym / sponsor ID
- PWS / TM006
- Conditions
- Prader-Willi Syndrome
- Keywords
- hyperphagia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanionaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects with PWS.
Detailed description
For the double-blind portion of the study, dosing will be initiated in a subgroup of adults who are 18-65 years of age. Following independent Data Monitoring Board review of subgroup safety data, and review and confirmation to proceed by FDA, enrollment of subjects <18 years of age will commence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo, Drug: TesometOnce-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated Tesomet dose from the double-blind period |
| Tesomet Low Dose | Experimental | Drug: TesometOnce-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period |
| Tesomet Medium Dose | Experimental | Drug: TesometOnce-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period |
| Tesomet High Dose | Experimental | Drug: TesometOnce-daily PO for 16 weeks during the double-blind period; then if eligible for OLE, once-daily dosing for 36 weeks of the highest tolerated dose from the double-blind period |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subject and their legally authorized representative must be willing to provide informed consent
- Confirmed genetic diagnosis of PWS
- Body mass index (BMI) within the following range at Screening:
- Female subjects must be of non-child-bearing potential
- Documented stable body weight
Key exclusion criteria (12 listed)
- Females who are pregnant, breastfeeding, or actively intending to become pregnant during the study
- Sitting BP that meets the following criteria after 5 minutes of rest at Screening:
- Type 1 diabetes mellitus
- History of dementia (eg, Alzheimer's disease, Parkinson's disease)
- History of bulimia or anorexia nervosa
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 |
|---|---|---|
| PlaceboInactive comparator | Other | Placebo |
| TesometAlso: tesofensine, metoprololFixed-dose combination | Drug | Placebo, Tesomet High Dose, Tesomet Low Dose, Tesomet Medium Dose |
Primary outcome
Hyperphagia
Time frame: Baseline to Week 16
Change in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score
5 secondary outcomes
Change in Body Weight
Time frame: Baseline to Week 16
Hyperphagia Severity (Caregiver)
Time frame: Baseline to Week 16
Hyperphagia Change (Caregiver)
Time frame: Week 16
PWS Severity (Clinician)
Time frame: Baseline to Week 16
Overall Status Change (Clinician)
Time frame: Week 16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Yes. The Sponsor will consider requests from qualified researchers for access to TM006 study materials
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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.
Sophie Guillaume, MS study director
Saniona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesomet in people with Prader-Willi Syndrome, run by Saniona at 1 site in United States.
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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hyperphagia (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2022.