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Effect of Tesofensine on Energy Balance in Humans.
Plain-language guide to NCT00428415: phase 1, phase 2 randomized trial of Tesofensine (non-peptide), 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00428415
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2007-03
- Completion (planned or actual)
- 2007-12
- Participants
- 32 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Tesofensine (non-peptide).
Purpose: To evaluate the effect of tesofensine on energy balance.
The registry classes the interventions as drug.
Who Took Part
The registry lists 32 planned participants were the target.
It was open to men only aged from 18 years up to 50 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Overweight to obese subjects with BMI 28 - 35 kg/m² otherwise healthy. Males 18 to 50 years of age, extremes included. Subjects should be able to comply with study procedures. Subjects giving written informed consent.
The full record lists 4 inclusion and 25 exclusion criteria; among the exclusions: subjects who have been smokers within the last year; malabsorptive intestinal disorders that can be assumed to affect the absorption of tesofensine; mental or psychiatric disorder based on medical history only.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Tesofensine (non-peptide) group and the comparison group should start out alike.
The Tesofensine (non-peptide) group and the comparison group ran side by side rather than switching.
As a double-blind Tesofensine (non-peptide) study, the assignments were hidden from both participants and investigators until the end.
It started in 2007-03 with completion listed for 2007-12.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Physical Measure(Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA, Spontaneous energy intake at lunch test, Data from questionnaires( Satiety & Appetite, POMS Brief) and Safety & Tolerability.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of Tesofensine (non-peptide) in 32 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tesofensine (non-peptide) compound page, all human trials.
Our Notes on the Compound
Tesofensine (non-peptide): An oral triple reuptake inhibitor (serotonin, norepinephrine, dopamine).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.