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.