Positive Topline Results from the TH001_1001 Clinical Trial Evaluating PreDiaWell® in Adults with Prediabetes

We are pleased to announce positive topline results from our prospective, randomised, controlled clinical trial (NCT05668819) TH001_1001, evaluating PreDiaWell® (TH-001) in combination with standard care versus standard care alone in adults with prediabetes.

The trial met its primary objectives, demonstrating that PreDiaWell® significantly improved glycaemic control and resulted in clinically meaningful weight loss compared to standard care.

Key Findings:

• Glycaemic Control: PreDiaWell® led to a statistically significant mean HbA1c reduction of -0.26% compared to -0.04% in the control group, yielding a mean difference of -0.22% (95% CI: -0.41 to -0.031; p=0.023). Notably, the magnitude of HbA1c reduction increased with greater exposure to PreDiaWell®.
• Weight Loss: Participants in the PreDiaWell® group experienced a mean weight loss of -3.70 kg, compared to -1.17 kg in the control group (p<0.001).
• BMI Reduction: PreDiaWell® resulted in a mean BMI reduction of -1.35 kg/m², compared to -0.46 kg/m² in the control group (p<0.001).
• Safety Profile: PreDiaWell® was well tolerated, with no device-related adverse effects reported.

Additional analyses indicated modest but non-statistically significant reductions in fasting blood glucose, insulin levels, waist circumference, hip circumference, and waist-to-hip ratio in the PreDiaWell® group.

The results of the TH001_1001 trial reinforce the potential of PreDiaWell® as a safe and effective digital therapeutic for prediabetes management, significantly improving glycaemic control and supporting weight loss in individuals at risk of type 2 diabetes.

Analyses of the full dataset from the study are ongoing and detailed findings from the trial will be presented at an upcoming scientific congress.