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Effect of Tesofensine on Weight Reduction in Patients With Obesity.
Plain-language guide to NCT00394667: phase 2 randomized trial of Tesofensine (non-peptide), 200 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00394667
- Phase
- phase 2
- Status
- completed
- Start
- 2006-09
- Completion (planned or actual)
- 2007-09
- Participants
- 200 (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 2) is built around Tesofensine (non-peptide).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 200 planned participants were the target.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Obese patients with 30 kg/m² ≤ BMI ≤ 40 kg/m². Males and females 18 to 65 years of age, extremes included. Patients continuously receiving diet therapy as well as instructions on exercise at least for 2 weeks run-in, who during the run-in before randomization do not gain weight (\< 2 kg). Patients should be able to comply with study procedures. Smoking habits should have been stable for at least 2 months.
The full record lists 7 inclusion and 31 exclusion criteria; among the exclusions: use of prescription medication as listed; positive serum pregnancy test for women of childbearing potential; pregnant or lactating women, or women who are planning to become pregnant within the next 8 months.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
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 2006-09 with completion listed for 2007-09.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percent change and absolute change in body weight.
It also tracked 4 secondary outcomes, for example Waist circumference, waist-hip ratio, change in BMI, Sagittal diameter and DEXA and Safety & Tolerability.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tesofensine (non-peptide) in 200 people.
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.