Trial · Interventional
WithdrawnPhase 2Registry dataStudy of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: 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
Overview
- Status
- Withdrawn
- Phase
- Phase 2
- Enrollment
- 0 participants (actual)
- Sponsor
- Saniona · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 11 Nov 2021
- Primary completion
- 9 Dec 2022
- Completion
- 9 Dec 2022
- First posted
- 7 Dec 2021
- Last update posted
- 13 Dec 2022
- Conditions
- Hypothalamic Obesity
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2Withdrawn
Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
NCT0514741511 Nov 2021 to 9 Dec 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will evaluate the safety and efficacy of Tesomet (tesofensine + metoprolol) in subjects 18 years of age or older, with HO
Interventions
- PlaceboOther
- TesometDrug
Arms4
Placebo comparator
Placebo
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated Tesomet dose from the double-blind period
Experimental
Tesomet Low Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
Experimental
Tesomet Medium Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
Experimental
Tesomet High Dose
Once-daily PO for 36 weeks during the double-blind period; then if continued eligible for OLE, once-daily dosing for 36 weeks at the highest tolerated dose from the double-blind period
Primary outcomes1
Outcomes the sponsor listed as primary.
Body weight (%)
Time frame · Baseline to Week 36
Registry description
Percentage change in body weight
Secondary outcomes(4)
Body weight loss
Time frame · Week 36
Registry description
Proportion of subjects who meet pre-specified thresholds for body weight loss
Body weight (kg)
Time frame · Baseline to Week 36
Registry description
Change in body weight in kilograms
Waist circumference (cm)
Time frame · Baseline to Week 36
Registry description
Change in waist circumference in centimeters
Body Mass Index (BMI)
Time frame · Baseline to Week 36
Registry description
Change in BMI
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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