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.
Sodium pentaborate pentahydrate showed a statistically significant reduction in body weight and BMI in a short-term trial, but further research is needed to confirm these findings and assess long-term safety.
Where it sits
this study against the rest of the slu-pp-332 (exercise mimetic) corpusSummary and findings
This study assessed the safety and efficacy of sodium pentaborate pentahydrate (NaB) in individuals with overweight or obesity. A total of 177 adults were randomized to receive placebo or NaB at doses of 200, 400, 600, 800, or 1,000 mg for 12 weeks. The primary exploratory efficacy outcome was the percentage change in body weight from baseline to week 12.
Abstract
The present study aimed to examine the short-term safety and tolerability of sodium pentaborate pentahydrate (NaB) and to explore preliminary efficacy and dose selection as secondary objectives in individuals with overweight or obesity. In this randomized, double-blind, placebo-controlled, phase 1/2 trial, conducted from July 2024 to January 2025, 177 adults with overweight or obesity were randomized, of whom 116 completed the 12-week trial. Participants received placebo or NaB at doses of 200, 400, 600, 800, or 1,000 mg for 12 weeks, alongside a standardized diet and exercise programme. The primary safety objective was to investigate short-term safety and tolerability through adverse events, hypoglycaemic episodes, gastrointestinal adverse events, and changes in haematological and biochemical parameters. The primary exploratory efficacy outcome was percentage change in body weight from baseline to week 12. Secondary and exploratory efficacy outcomes included body weight, body mass index (BMI), waist and hip circumferences, waist-to-hip ratio, glycaemic markers, lipid parameters, and blood pressure. Baseline characteristics were broadly similar across groups (all p ≥ 0.05), and no major short-term safety signal was observed. Mean body weight decreased in the 400 mg (-2.6 kg), 600 mg (-1.2 kg), and 1,000 mg groups (-3.1 kg). Compared with placebo, the 1,000 mg dose resulted in the largest reductions in body weight (mean difference, -2.30 kg; p = 0.01) and BMI (mean difference, -0.85 kg/m2; p = 0.02). The 1,000 mg dose showed preliminary efficacy for reducing body weight and BMI over 12 weeks compared with placebo, with no major short-term safety signal and no clinically meaningful changes in renal, hepatic, or haematological markers. All reported adverse events were mild. These short-term findings are exploratory and require confirmation in future phase 3 trials with extended follow-up to investigate long-term safety and efficacy.
Background
This study addresses the safety and efficacy of sodium pentaborate pentahydrate (NaB) in individuals with overweight or obesity. Prior research has indicated various interventions for weight management, but the specific effects of NaB were not well established. Understanding the safety profile and preliminary efficacy of NaB is crucial for future clinical applications.
Methods
This was a randomized, double-blind, placebo-controlled, phase 1/2 trial involving 177 adults with overweight or obesity. Participants were randomized to receive placebo or NaB at doses of 200, 400, 600, 800, or 1,000 mg for 12 weeks, alongside a standardized diet and exercise program. The primary outcome was short-term safety and tolerability, while exploratory efficacy outcomes included percentage change in body weight and BMI.
Results
At 12 weeks, the 1,000 mg NaB group showed a mean difference in body weight of -2.30 kg compared to placebo (p=0.01) and a mean difference in BMI of -0.85 kg/m2 (p=0.02). No major short-term safety signals were reported, and all adverse events were mild. Baseline characteristics were similar across groups (all p≥0.05).
Interpretation
The results indicate a statistically significant reduction in body weight and BMI for the 1,000 mg NaB group compared to placebo. However, the clinical significance of these findings may be limited due to the small effect sizes and the short duration of the study. Additionally, the exploratory nature of the findings and the lack of long-term follow-up raise concerns about the robustness of the conclusions.
Key findings
- Mean body weight decreased in the 400 mg (-2.6 kg), 600 mg (-1.2 kg), and 1,000 mg groups (-3.1 kg).
- The 1,000 mg dose resulted in the largest reductions in body weight (mean difference, -2.30 kg; p=0.01).
- The 1,000 mg dose also showed a mean difference in BMI of -0.85 kg/m2 (p=0.02).
- No major short-term safety signal was observed.
- All reported adverse events were mild.
Limitations
- 177 participants, with only 116 completing the trial.
- Short follow-up of 12 weeks.
- Exploratory findings requiring confirmation in phase 3 trials.
- No major safety signals, but all adverse events were mild.