Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Predi… (NCT07286747) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)
Germany390 participantsStarted 2026-03-03
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. 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.
✕. Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines.
✕. Participants with relevant medical conditions (based on evaluation of medical history and screening assessments), unstable and uncontrolled underlying diseases, e.g., hypothyroidism, asthma, COPD or arterial hypertension, can be excluded per judgment of the Investigator.
✕. Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase \[\> 3-fold compared to normal range\]).
✕. Current infection with hepatitis B or C.
✕. Clinically relevant abnormal findings in medical history or screening assessments which, in the opinion of the Investigator, may put the participant at risk when participating in the trial or provide difficulties in interpreting the trial data.
✕. Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin.
✕. Alcohol or drug abuse within the last 2 years at the discretion of the Investigator.