Evaluation of the efficacy and safety of controlled-release phentermine/topiramate in adults with obesity in Korea: A randomized, double-blind, placebo-controlled, phase 4 trial (QUEEN's study).

ABSTRACT:

Aims

This study evaluated the efficacy and safety of a combination of phentermine and delayed-release topiramate (PHEN/TPM CR) versus placebo as an adjunct to standard lifestyle recommendations in Korean adults.

Materials and methods

This 56-week, randomized, double-blind, placebo-controlled, phase 4 trial enrolled adults (age 19-70 years) with obesity (BMI ≥ 25 kg/m²) at eight sites in South Korea. After a 12-week lifestyle programme, participants were randomly assigned in a 1:1 ratio to receive PHEN/TPM CR or placebo. PHEN/TPM CR was commenced at 3.75 mg/23 mg daily for 14 days and increased to 7.5 mg/46 mg daily, and to 15 mg/92 mg if 3% weight loss was not achieved after 12 weeks. The primary outcomes were percentage change in body weight from baseline to Week

SUBMITTER: Hong S 

PROVIDER: S-EPMC11802386 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature