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Effect of Tesofensine on Bodyweight Loss, Body Composition, and Quality of Life in Obese Patients: A Randomised, Double-Blind, Placebo-Controlled Trial

rct • 2008 • ID: 18950853

Low Confidence RCT

Primary source: [Open]

Linked compounds: tesofensine

Outcomes summary

Phase 2, randomized, double-blind, placebo-controlled trial in 203 obese patients; tesofensine 0.5 mg produced a mean weight loss of 9.2% greater than diet and placebo (p<0.0001), while 1.0 mg produced 10.6% greater weight loss; the highest dose approximately doubled the weight loss observed with currently available anti-obesity drugs; fat mass reduction was preserved without significant loss of lean tissue.

Limitations

Trial was not confirmatory (Phase 2); expression of concern later published by The Lancet regarding data integrity questions; safety concerns including increased heart rate (7.4 bpm increase with 0.5 mg) and adverse events requiring Phase 3 confirmation; limited duration (24 weeks) relative to chronic use.

Notes

Primary source: PMID 18950853 (see PubMed link on this page).