A Phase II, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) for Inducing Remission in Subjects With Prediabetes
The goal of this clinical trial is to prevent the change from prediabetes (a pre-stage of type 2 diabetes mellitus (T2DM)) to T2DM in participants with prediabetes using oral CIR-NA (a nicotinic acid formulation that is designed to be released after reaching the ileum) which targeted the gut microbiota. The main questions it aims to answer are: 1. Is CIR-NA effective and does it prevent the change from prediabetes to T2DM? 2. Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes? Researchers will compare CIR-NA to a placebo (a look-alike substance that contains no drug) in terms of an extended safety evaluation including safety laboratory assessments, physical examination, vital signs and 12-lead ECG. Participants will: Take CIR-NA or a placebo every day for 26-weeks. Visit the clinic at week 1 and subsequently once every 4 weeks for checkups and tests. Receive standardized lifestyle recommendations regarding nutrition and physical activity during the intervention.
• Male and female participants ≥ 18 to \< 80 years of age (at the time of signing the informed consent).
• Body mass index ≥ 20 kg/m².
• Ability to understand and comply with the protocol.
• Signed written informed consent.
• Diagnosed prediabetes according to the current EASD/DDG guidelines. Prediabetes is present if at least one value is in the prediabetes range, but no value is in the T2DM range.
• Subgroup-specific: MASLD fibrosis score ≥ -1.455.