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

NCT07286747 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Interventions

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.

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Matthias Laudes, Prof. Dr. · University Medical Center Schleswig-Holstein, Campus Kiel

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2028-05-01
Completion
2028-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286747 on ClinicalTrials.gov