Randomized, double-blind, placebo-controlled trial of orlistat for weight loss in adolescents

David Maahs, Daniela Gonzalez De Serna, Ronette L. Kolotkin, Shawn Ralston, Jeffrey Sandate, Clifford Qualls, David S. Schade

Research output: Contribution to journalArticlepeer-review

109 Scopus citations


Objective: To evaluate the efficacy of orlistat to enhance weight loss in obese adolescents. Methods: The study was a 6-month randomized, double-blind, placebo-controlled trial to compare the effects of orlistat (120 mg orally 3 times a day) and placebo on reduction of body mass index (BMI). Forty adolescents between 14 and 18 years of age with a mean BMI of 40 kg/m2 entered the protocol between December 2002 and February 2003. Study subjects stayed overnight in the General Clinical Research Center, during which dietary records were reviewed and lifestyle recommendations were given. The study participants received either orlistat (120 mg orally 3 times a day) or placebo and were assessed monthly for 6 months. At 0, 3, and 6 months, fasting laboratory tests were performed. The primary end point was the change in BMI from baseline to 6 months. Secondary outcomes included changes in weight, lean body mass, and results of blood chemistry studies. Results: No statistically significant difference was noted between the 2 study groups for decrease in BMI from baseline to 6 months (P = 0.39). The decrease in BMI within the orlistat group (-1.3 ± 1.6 kg/m2; P = 0.04) and within the placebo group (-0.8 ± 3.0 kg/m2; P = 0.02), however, was statistically significant. Laboratory measurements did not differ between the 2 groups. In comparison with the placebo group, the orlistat group had increased adverse events, primarily gastrointestinal symptoms and findings. Conclusion: In this study of obese adolescents, orlistat did not significantly reduce BMI in comparison with placebo at 6 months.

Original languageEnglish (US)
Pages (from-to)18-28
Number of pages11
JournalEndocrine Practice
Issue number1
StatePublished - 2006
Externally publishedYes

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology


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