Actively Recruiting
Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)
Led by University Hospital Schleswig-Holstein · Updated on 2026-04-01
390
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 to less than 80 years at the time of consent
- Body mass index of 20 kg/m² or higher
- Ability to understand and follow the study protocol
- Signed written informed consent
- Diagnosed with prediabetes based on current guidelines, with no values in the diabetes range
- MASLD fibrosis score of -1.455 or higher
You will not qualify if you...
- History or presence of type 2 diabetes mellitus
- Relevant unstable or uncontrolled medical conditions such as hypothyroidism, asthma, COPD, or arterial hypertension as judged by the investigator
- Renal impairment with glomerular filtration rate below 60 ml/min/1.73
- Liver enzyme levels more than three times the normal range
- Current infection with hepatitis B or C
- Any clinically relevant abnormal findings that may increase risk or interfere with data interpretation
- Current or past malignancy except fully removed basal or squamous cell skin carcinoma
- Alcohol or drug abuse within the last 2 years
- Conditions preventing MRI or MRS imaging
- Use of medications or supplements that cannot be stopped 3 weeks before baseline and during the trial, except allowed pain, allergy, hormone, and contraceptive medications
- Use of antibiotics within 8 weeks before starting the study drug
- Long-term use of high doses of proton pump inhibitors or similar drugs
- Known allergy to any component of the study tablets
- Participation in another clinical trial within 4 weeks or use of investigational drugs within 8 weeks prior
- Under legal supervision or guardianship
- Dependency on the investigator or sponsor
- Pregnant or breastfeeding women
- Women of childbearing potential not using highly effective contraception until 1 month after last dose
- Male participants with female partners of childbearing potential not using highly effective contraception until 1 month after last dose
- Any other medical or personal condition that the investigator determines makes participation unsuitable
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
2
University of Leipzig Medical Center
Leipzig, Germany, 04103
Actively Recruiting
Research Team
C
Corinna Geisler, PhD
CONTACT
M
Matthias Laudes, Prof. Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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