Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)
NCT ID: NCT07286747
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
390 participants
INTERVENTIONAL
2026-01-01
2028-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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CIR-NA 200
CIR-NA 200 mg once daily
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.
CIR-NA Placebo
Placebo once daily
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.
CIR-NA 100
CIR-NA 100 mg once daily
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
79 Years
ALL
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Principal Investigators
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Matthias Laudes, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Schleswig-Holstein, Campus Kiel
Locations
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University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LA1347/6-1
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-519903-88-00
Identifier Type: CTIS
Identifier Source: secondary_id
CONCEPT
Identifier Type: -
Identifier Source: org_study_id