Oral ileum-targeted controlled-release nicotinic acid to reverse prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized, double-blind, placebo-controlled Phase 2 trial compares two daily doses (100 mg and 200 mg) of controlled-ileal-release nicotinic acid (CIR-NA) to placebo over a 26-week intervention plus a 4-week follow-up. Adults with prediabetes and BMI ≥20 kg/m² are randomized 1:1:1 across the three arms, receiving one indistinguishable tablet daily with regular clinic visits for safety labs, 12-lead ECGs, vitals, and physical exams. The trial combines standardized lifestyle recommendations with blinded drug/placebo exposure to measure remission of prediabetes to normoglycemia and to confirm safety observations from Phase 1. About 390 participants will be enrolled with visits at week 1 and then every 4 weeks during treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female participants ≥ 18 to \< 80 years of age (at the time of signing the informed consent).
2. Body mass index ≥ 20 kg/m².
3. Ability to understand and comply with the protocol.
4. Signed written informed consent.
5. 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.
6. Subgroup-specific: MASLD fibrosis score ≥ -1.455.

Exclusion Criteria:

1. Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines.
2. 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.
3. Renal impairment (glomerular filtration rate \<60 ml/min/1.73).
4. Impairment of hepatic function (one or more of liver enzymes alanine transaminase, aspartate transaminase and gamma glutamyl transferase \[\> 3-fold compared to normal range\]).
5. Current infection with hepatitis B or C.
6. 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.
7. Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin.
8. Alcohol or drug abuse within the last 2 years at the discretion of the Investigator.
9. Subgroup-specific: Any circumstances which could contradict MRI and MRS imaging. For details, see Informed Consent Form (ICF) for additional examinations.
10. Regular use of any prescribed or over-the-counter medication, food supplements or herbal preparations, which cannot be terminated 3 weeks before baseline and during the full duration of the trial. Pain medication (e.g., ibuprofen or paracetamol), topical allergy medicines, hormone replacement therapies and oral contraceptives according to label are allowed. Medications in stable doses for controlling stable underlying diseases (see exclusion criterion 2) are also allowed per judgment of the Investigator.
11. Use of antibiotics (systemic or gut-acting \[non-absorbed\]) within 8 weeks prior to the first dose of IMP.
12. Long term use of higher doses of proton pump inhibitors, targeted H2-receptor antagonists or antacid formulations (i.e., doses equivalent to \> 40 mg pantoprazole per day).
13. Known hypersensitivity towards any component of the CIR-NA or placebo tablets.
14. Participation in a clinical trial (as defined in the clinical trial regulation (CTR)), currently or within 4 weeks prior to screening for this trial or intake of an IMP within the last 8 weeks or 5 half-lives (whichever is longer) prior to screening (or longer, if necessary, at the Investigator's discretion).
15. Participants under legal supervision or guardianship, including participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
16. Participants who are dependent on the Investigator or the Sponsor.
17. Pregnant or breastfeeding women.
18. Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP.
19. Male participants with female partners of childbearing potential who are not willing to use a highly effective contraception till at least 1 month after last dosing of IMP.
20. Any other circumstances or medical conditions which could contradict a trial participation and lead the Investigator to assess the participant as unsuitable for trial participation.

Where it's running

• University Medical Center Schleswig-Holstein, Campus Kiel
  Kiel, Germany Recruiting
• University of Leipzig Medical Center
  Leipzig, Germany Recruiting
• Charité-Universitätsmedizin Berlin
  Berlin, Germany Not yet recruiting
• University Hospital Schleswig-Holstein (UKSH)
  Lübeck, Germany Not yet recruiting
• TUM University Hospital
  München, Germany Not yet recruiting
• University Hospital Tübingen
  Tübingen, Germany Not yet recruiting

Study contacts

• Principal investigator: Matthias Laudes, Prof. Dr. — University Medical Center Schleswig-Holstein, Campus Kiel
• Study coordinator: Corinna Geisler, PhD
• Email: corinna.geisler@uksh.de
• Phone: +4943150022446

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Food-i-Sense Analytics: Using AI to Understand How Your Glucose Changes Day to Day

  This observational study tests an AI tool to classify adults without diabetes into glucotypes using CGM data to personalize future dietary advice.

  Recruiting IMDEA Food · Madrid, Madrid · NCT07626658

• Eating almonds before meals to help keep blood sugar steady

  This study tests whether a small premeal serving of almonds can blunt blood sugar spikes in adults at risk for type 2 diabetes.

  Recruiting Pennington Biomedical Research Center · Baton Rouge, Louisiana · NCT07603739

• Do different fish oils lower diabetes risk factors in people at high risk

  This study tests whether EPA or DHA fish oil works better than corn oil at improving markers linked to type 2 diabetes in adults who are at high risk.

  Recruiting Phase 2 Institut de Recherches Cliniques de Montreal · Montreal, Quebec · NCT07575438

• Risk-informed shared-decision making to help people with prediabetes prevent diabetes

  This study tests whether a risk-informed shared decision-making visit or a plain patient portal message can help adults with prediabetes take steps to prevent diabetes.

  Recruiting Johns Hopkins University · Frederick, Maryland · NCT07553325

• Akkermansia muciniphila plus berberine to improve insulin sensitivity in night-shift workers

  This trial tests whether taking Akkermansia muciniphila together with berberine can improve insulin sensitivity in people who work regular night shifts and have overweight or prediabetes.

  Recruiting FH Joanneum Gesellschaft mbH · Graz, Styria · NCT07440147

• Daily Lab4P probiotic to improve thinking and metabolic health in overweight young adults with mild glucose regulation problems.

  This 12-week trial will test whether taking a daily Lab4P probiotic can improve memory, thinking speed, and blood sugar control in overweight 18–40-year-olds with mildly impaired glucose regulation.

  Recruiting Leeds Beckett University · Leeds, Greater Manchester · NCT07073781

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.