Assessment of the safety and efficacy of sodium pentaborate pentahydrate in individuals with overweight and obesity: a randomized, double-blind, placebo-controlled, phase 1/2 dose-finding trial.
Fikrettin Şahin, Nahid Karamzad, Reza Aletaha et al.
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In 30 seconds
This randomized, double-blind, placebo-controlled phase 1/2 trial evaluated the safety and preliminary efficacy of sodium pentaborate pentahydrate in 177 adults with overweight or obesity over 12 weeks. The 1,000 mg dose showed significant reductions in body weight (mean difference, -2.30 kg; p = 0.01) and BMI (mean difference, -0.85 kg/m²; p = 0.02) compared to placebo, with no major safety concerns.
Key findings
- The 1,000 mg dose of sodium pentaborate resulted in a mean weight reduction of -2.30 kg compared to placebo.
- Participants receiving 1,000 mg also experienced a mean BMI decrease of -0.85 kg/m² versus placebo.
- No major short-term safety signals were observed, with all adverse events reported as mild.
- 116 out of 177 participants completed the 12-week trial.
Why it matters
Understanding the safety and efficacy of new treatments for overweight and obesity is crucial for clinicians. This study provides preliminary evidence that sodium pentaborate pentahydrate may be a viable option for weight management, warranting further investigation.