drugset / Trial / NCT00394667
Effect of Tesofensine on Weight Reduction in Patients With Obesity.
RandomizedParallel-groupDouble-blindTreatment
Summary
Purpose: To evaluate the efficacy on weight reduction, metabolic parameters and safety of tesofensine versus placebo in obese patients
Timeline
- Start
- 2006-09
- Primary completion
- —
- Completion
- 2007-09
Outcome
Met primary endpoint
paper mean weight loss of 4.5% (0.87), 9.2% (0.91), and 10.6% (0.84), respectively, greater than diet and placebo (p<0.0001). PMID 18950853 ↗
Publications
- Background Expression of concern--effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Apr 6;381(9873):1167. doi: 10.1016/S0140-6736(13)60778-3. No abstract available.
- Gilbert JA, Gasteyger C, Raben A, Meier DH, Astrup A, Sjodin A. The effect of tesofensine on appetite sensations. Obesity (Silver Spring). 2012 Mar;20(3):553-61. doi: 10.1038/oby.2011.197. Epub 2011 Jun 30.
- Astrup A, Madsbad S, Breum L, Jensen TJ, Kroustrup JP, Larsen TM. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Nov 29;372(9653):1906-1913. doi: 10.1016/S0140-6736(08)61525-1. Epub 2008 Oct 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tesofensine | Small molecule | 0.25 mg | — |
| Subject | Tesofensine | Small molecule | 0.5 mg | — |
| Subject | Tesofensine | Small molecule | 1 mg | — |