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Tesofensine for Weight Reduction in Obesity
NCT00394667Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2006
- Countries
- 1
- Sponsor
- NeuroSearch
- Modality
- Small Molecules
- Drugs
- tesofensine
- Conditions
- obesity
01
Overview
Phase 2, randomised, double-blind trial of tesofensine in obesity (4 arms), sponsored by NeuroSearch. Primary endpoints: Percent change in body weight at 24 weeks and Absolute change in body weight at 24 weeks. Started Sep 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Tesofensine 0.25 mg
Tesofensine 0.25 mg once daily
Tesofensine 0.5 mg
Tesofensine 0.5 mg once daily
Tesofensine 1.0 mg
Tesofensine 1.0 mg once daily
Placebo
Placebo once daily
03
Who it enrols
Obese patients (BMI 30-40) aged 18-65. Excludes patients with diabetes (unless diet-controlled with specific glucose limits, though generally excluded in practice), uncontrolled hypertension, significant cardiovascular disease, psychiatric disorders, or glaucoma.
04
Endpoints
Primary
Percent change in body weight
Absolute change in body weight
Secondary
Waist circumference
Metabolic parameters
Safety and Tolerability
05
Results
Primary endpoints met
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