PMID-18950853 – Tesofensine Phase 2 Obesity Trial
Astrup A, 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;372(9653):1906-1913.
Quick Reference
| Property | Value |
|---|---|
| PMID | 18950853 |
| DOI | 10.1016/S0140-6736(08)61525-1 |
| Year | 2008 |
| Journal | The Lancet |
| Study Type | RCT |
| Evidence Level | II |
| Sample | 203 obese patients (BMI 30-40 kg/m2) |
| Peptide(s) Studied | Tesofensine |
Key Findings
- Mean weight loss with diet + placebo was 2.0% over 24 weeks
- Tesofensine 0.25 mg produced 4.5% greater weight loss vs placebo (p<0.0001)
- Tesofensine 0.5 mg produced 9.2% greater weight loss vs placebo (p<0.0001)
- Tesofensine 1.0 mg produced 10.6% greater weight loss vs placebo (p<0.0001)
- Quality of life improvements correlated with weight loss magnitude
- Body composition analysis showed preferential fat mass loss
Study Design
Phase 2, multicentre, randomised, double-blind, placebo-controlled trial conducted at 5 Danish obesity management centres. 203 patients randomized to tesofensine 0.25 mg, 0.5 mg, 1.0 mg, or placebo for 24 weeks. All groups received a controlled energy-deficit diet. Primary endpoint: percent body weight change.
Limitations
- 24-week duration; long-term efficacy/safety unknown
- Moderate sample size (n=203)
- Single-country study (Denmark only)
- No Phase 3 confirmatory trial conducted subsequently
- Heart rate increased 7.4 bpm in 0.5 mg group (p=0.0001)
Clinical Relevance
This is the pivotal Phase 2 trial demonstrating tesofensine's potential as an anti-obesity agent. The 0.5 mg dose appeared to have the best risk-benefit profile, producing ~9% weight loss with manageable side effects. The weight loss magnitude exceeded that of all FDA-approved anti-obesity drugs at the time. However, the lack of Phase 3 completion limits clinical translation.
Related
#research #RCT #tesofensine #evidence-level-II