NCT07286747

Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study is a multi-centre, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of CIR-NA in participants with prediabetes. The trial includes a 26-week intervention period, which is expected to provide adequate time for prediabetes remission and a 4-week follow-up (FU) period. A total of 390 male and female participants with a BMI of ≥ 20 kg/m² with prediabetes will be random-ised into three arms with 130 participants each in the CIR-NA (100 mg/d or 200 mg/d CIR-NA) and placebo groups. During the intervention, two indistinguishable tablets (CIR-NA and/or placebo) will be administered orally once daily. After screening and baseline assessment (including randomisation and IMP dispensing), 7 regular visits during treatment and one FU visit after 4 weeks are scheduled.

Conditions

• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Interventions

Type	Name	Description
DRUG	controlled-ileal-release nicotinic acid as multiple dose 100 mg/day	130 participants will receive CIR-NA (100 mg/d). Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.
DRUG	controlled-ileal-release nicotinic acid as multiple dose 200 mg/day	130 participants will receive CIR-NA (200 mg/d). Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.
DRUG	controlled-ileal-release nicotinic acid as multiple dose placebo	130 participants will receive placebo. Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.

Timeline

• Start date: 2026-03-03
• Primary completion: 2028-05-01
• Completion: 2028-12-31
• First posted: 2025-12-16
• Last updated: 2026-04-01

Locations

2 sites across 1 country: Germany