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)
Primary result · Percentage change in body weightResult — go to the resultTreatment difference −6.1 % 95% CI −7.7 to −4.5Authors' conclusion
Administration of PHEN/TPM CR plus lifestyle intervention in Korean adults with obesity resulted in a greater reduction in body weight and adiposity than lifestyle intervention alone.
Study context
- Population
- Korean adults aged 19–70 years with obesity (BMI ≥ 25 kg/m²), 8 sites in South Korea, after a 12-week lifestyle programmerandomized 1:1
- Participants
- 232 adults
- Comparison
- PHEN/TPM CR vs placebo, as adjunct to lifestyle recommendations
- Primary endpoint
- Percentage change in body weight from baseline
- Follow-up
- Week 56
Methodological detailsdouble-blind, placebo-controlled, phase 4, 8 sites
- Double-blind
- Placebo-controlled
- Phase 4
- 8 sites
Primary result
Percentage change in body weight · 56 weeks
Treatment difference
−6.1 %
95% CI −7.7 to −4.5
P < 0.001
Change by group
PHEN/TPM CR
−8.3%
Placebo
−2.3%
PHEN/TPM CRvs Placebo
treatment difference −6.1 % (95% CI −7.7 to −4.5); P < 0.001
As reported in the abstract
Further findings
| Outcome | PHEN/TPM CR | Placebo | OR (95% CI) | P value | |
|---|---|---|---|---|---|
| ≥5% weight loss · 56 weeks | 68.5% | 25.0% | 6.4 (3.5–11.6) | P < 0.001 | |
| 0.050.21520Odds ratio (log scale) |
Safety
- Dizziness, paraesthesia and dry mouth more common with PHEN/TPM CR; most adverse events mild or moderate
Original publication
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). Diabetes Obes Metab. Published 20 December 2024. doi:10.
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