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Drug Therapy / Obesity / Anti Obesity Agents · Journal article
Adipocyte · August 24, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a phase 1/2 dose-finding trial of sodium pentaborate pentahydrate in 116 adults with overweight or obesity over 12 weeks. The 1,000 mg dose showed exploratory efficacy signals for body weight and BMI reduction versus placebo with no major short-term safety signals, but the authors emphasize these findings are preliminary and require confirmation in phase 3 trials.
Randomized, double-blind, placebo-controlled phase 1/2 dose-finding trial. Adults with overweight or obesity enrolled between July 2024 and January 2025; baseline characteristics broadly similar across groups.. Intervention: Sodium pentaborate pentahydrate at doses of 200, 400, 600, 800, or 1,000 mg daily for 12 weeks, combined with standardized diet and exercise programme. Compared with: Placebo for 12 weeks with standardized diet and exercise programme. n = 116. Not stated in the provided text.
1,000 mg dose resulted in mean body weight reduction of −3.1 kg (placebo-adjusted mean difference −2.30 kg; p = 0.01) 1,000 mg dose resulted in BMI reduction of mean difference −0.85 kg/m² versus placebo (p = 0.02) 400 mg dose showed mean body weight decrease of −2.6 kg; 600 mg dose showed −1.2 kg
Very short follow-up (12 weeks); long-term safety and efficacy unknown No major short-term safety signal observed; all reported adverse events were mild
These findings are too preliminary for clinical use. The modest absolute weight loss (2.3 kg placebo-adjusted), short duration, small sample per group, and lack of prior human evidence mean this compound requires larger, longer-term phase 3 confirmation before any therapeutic consideration. The mild adverse event profile is reassuring but cannot predict long-term tolerability.
Phase 1/2 dose-finding trial with modest sample size (116 completers) and short 12-week duration showing exploratory efficacy signals without major safety concerns, but requiring confirmation in phase 3 trials before clinical application.
As stated by the source record.
Quoted from the source exactly as published.
These findings are too preliminary for clinical use. The modest absolute weight loss (2.3 kg placebo-adjusted), short duration, small sample per group, and lack of prior human evidence mean this compound requires larger, longer-term phase 3 confirmation before any therapeutic consideration. The mild adverse event profile is reassuring but cannot predict long-term tolerability.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
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.
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