Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Phase 2CONCEPTNCT07286747
Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)
A Phase 2 study of Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), run by University Hospital Schleswig-Holstein at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 6 sitesGermany
- Study dates
- 3 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subgroup-specific: MASLD fibrosis score ≥ -1.455.
Who cannot join
- 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.
- Renal impairment (glomerular filtration rate <60 ml/min/1.73).
- 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.
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- 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.
- Subgroup-specific: Any circumstances which could contradict MRI and MRS imaging. For details, see Informed Consent Form (ICF) for additional examinations.
- 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.
- Use of antibiotics (systemic or gut-acting [non-absorbed]) within 8 weeks prior to the first dose of IMP.
- 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).
- Known hypersensitivity towards any component of the CIR-NA or placebo tablets.
- 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).
- 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.
- Participants who are dependent on the Investigator or the Sponsor.
- Pregnant or breastfeeding women.
- Women of childbearing potential (WoCBP) not using highly effective contraception till at least 1 month after last dosing of IMP.
- 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.
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Not yet recruiting
Charité-Universitätsmedizin Berlin
Berlin, 10117
Knut Mai, Prof. Dr. med., +49-30 450 514 252, knut.mai@charite.de
Stefan Kabisch, Dr. med., +49-30 450 514 429, stefan.kabisch@charite.de
- Recruiting
University Medical Center Schleswig-Holstein, Campus Kiel
Kiel, 24105
Corinna Geisler, PhD, +4943150022246, concept.studie.kiel@uksh.de
- Recruiting
University of Leipzig Medical Center
Leipzig, 04103
Matthias Blüher, Prof. Dr. med., +493419722901, matthias.blueher@medizin.uni-leipzig.de
Sarah Victoria Frenzel, +493419722926, sarahvictoria.frenzel@medizin.uni-leipzig.de
- Not yet recruiting
University Hospital Schleswig-Holstein (UKSH)
Lübeck, 23538
Svenja Meyhöfer, PD Dr., +49451 31017827, svenja.meyhoefer@uksh.de
Anne Meinke, +49451 31017434, anne.meinke@uksh.de
- Not yet recruiting
TUM University Hospital
München, 80809
Katharina Timper, Prof. Dr. med., +49 89 289 249 30, Katharina.timper@mri.tum.de
Bärbel Huber, Dr. med., +49 89 289 249 15, baerbel.huber@tum.de
- Not yet recruiting
University Hospital Tübingen
Tübingen, 72076
CONCEPT Trial-Coordination, +497071 29-80687, stoffwechsel@med.uni-tuebingen.de
Hannah Ploppa, +497071 29-80668, Hannah.ploppa@med.uni-tuebingen.de
About this study
Official title: A Phase II, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) for Inducing Remission in Subjects With Prediabetes
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:
- Is CIR-NA effective and does it prevent the change from prediabetes to T2DM?
- Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes?
Read more
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.
Read the detailed description
The study is a multi-centre, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of CIR-NA in participants with prediabetes. The trial includes a 26-week intervention period, which is expected to provide adequate time for prediabetes remission and a 4-week follow-up (FU) period.
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.
- Being tested
- controlled-ileal-release nicotinic acid as multiple dose 100 mg/day, controlled-ileal-release nicotinic acid as multiple dose 200 mg/day, controlled-ileal-release nicotinic acid as multiple dose placebo
- Medical subject headings
- Prediabetic State, Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled-ileal-release nicotinic acid as multiple dose 100 mg/dayDrug
Also called CIR-NA 100 mg
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/dayDrug
Also called CIR-NA 200 mg
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 placeboDrug
Also called Placebo
130 participants will receive placebo. Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| CIR-NA 200 | Active comparator | CIR-NA 200 mg once daily Receives: Drug: controlled-ileal-release nicotinic acid as multiple dose 200 mg/day |
| CIR-NA Placebo | Placebo comparator | Placebo once daily Receives: Drug: controlled-ileal-release nicotinic acid as multiple dose placebo |
| CIR-NA 100 | Active comparator | CIR-NA 100 mg once daily Receives: Drug: controlled-ileal-release nicotinic acid as multiple dose 100 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of prediabetes at week 26
Remission of prediabetes at week 26 has been achieved when all values of HbA1c, fasting plasma glucose and 2-h-oGTT glucose are in the healthy range according to EASD/DDG guidelines.
Measured: up to 185 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start3 Mar 2026
- Primary completion1 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Laudes, Prof. Dr., Principal investigator, University Medical Center Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286747
- Sponsor's protocol ID
- CONCEPT
- Other IDs
- LA1347/6-1, 2024-519903-88-00
- Acronym
- CONCEPT
- Status last verified
- Mar 2026
- First submitted
- 3 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No