This randomized, double‑blind, placebo‑controlled phase 1/2 trial investigated the short‑term safety and tolerability of sodium pentaborate pentahydrate (NaB) in adults with overweight or obesity, with exploratory, dose‑finding efficacy objectives. The trial ran from July 2024 to January 2025. The primary safety objective assessed adverse events, hypoglycaemic episodes, gastrointestinal adverse events, and changes in routine haematological and biochemical laboratory 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.
A total of 177 adults with overweight or obesity were randomized across treatment groups. Of these, 116 participants completed the 12‑week intervention period. Participants received either placebo or NaB at doses of 200, 400, 600, 800, or 1,000 mg daily for 12 weeks. All participants followed a standardized diet and exercise programme during the study. Baseline characteristics were reported as broadly similar across groups (all p ≥ 0.05), indicating comparability between randomised arms in measured variables.
The trial’s short‑term safety assessments found no major safety signals. All reported adverse events were described as mild. Evaluations of renal, hepatic, and haematological laboratory markers did not show clinically meaningful changes over the 12‑week period. The report specifically notes the absence of major short‑term safety concerns in relation to hypoglycaemic episodes and gastrointestinal adverse events as predefined safety endpoints. These findings apply to the 12‑week timeframe of the present study and are characterized by the authors as short‑term and exploratory.
Percentage change in body weight from baseline to week 12 was the primary exploratory efficacy endpoint. Mean changes in body weight over 12 weeks differed across dose groups. The 400 mg group experienced a mean weight decrease of −2.6 kg, the 600 mg group −1.2 kg, and the 1,000 mg group −3.1 kg. When compared with placebo, the 1,000 mg dose produced the largest and statistically significant reductions in both body weight (mean difference −2.30 kg; p = 0.01) and BMI (mean difference −0.85 kg/m2; p = 0.02). These results led the investigators to identify the 1,000 mg dose as having preliminary efficacy for reducing body weight and BMI over the 12‑week study period.
Secondary and exploratory outcomes included anthropometric measures beyond body weight (waist and hip circumferences, waist‑to‑hip ratio) as well as measures of glycaemic control, lipid parameters, and blood pressure. The abstract reports these outcomes as predefined secondary and exploratory endpoints, but it does not provide detailed numerical results for each parameter in the summary text. The source reports that no clinically meaningful changes in renal, hepatic, or haematological markers were observed. Specific data for glycaemic markers, lipid changes, or blood pressure effects were not detailed in the abstract provided.
The authors emphasize that these findings are short‑term and exploratory. While the 1,000 mg dose demonstrated preliminary efficacy for weight and BMI reduction with no major short‑term safety signal, all reported adverse events were mild and no clinically meaningful laboratory abnormalities were observed over 12 weeks. The authors conclude that confirmation is needed in future phase 3 trials with extended follow‑up to establish long‑term safety and efficacy. The abstract does not report longer‑term safety data, durability of weight loss beyond 12 weeks, or detailed subgroup analyses; these aspects remain to be evaluated in larger, longer trials.
Clinicians and investigators should interpret the reported short‑term, dose‑finding results cautiously and await larger, longer studies for definitive evidence on safety and therapeutic value.