Efficacy and Safety of Oral Controlled-release Nicotinic Acid (CIR-NA) for the Remission of Prediabetes. (CONCEPT)

NCT07286747 | Recruiting Phase 2 DMC

• 3 other identifiers: CONCEPTLA1347/6-12024-519903-88-00
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 2

Brief 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. 1.Is CIR-NA effective and does it prevent the change from prediabetes to T2DM?
2. 2.Is the safety of CIR-NA that was observed in the Phase I clinical trial confirmed in subjects with prediabetes?

Conditions

Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 185 days

Study Arms (3)

CIR-NA 200

ACTIVE COMPARATOR

CIR-NA 200 mg once daily

Drug: controlled-ileal-release nicotinic acid as multiple dose 200 mg/day

CIR-NA Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: controlled-ileal-release nicotinic acid as multiple dose placebo

CIR-NA 100

ACTIVE COMPARATOR

CIR-NA 100 mg once daily

Drug: controlled-ileal-release nicotinic acid as multiple dose 100 mg/day

Interventions

controlled-ileal-release nicotinic acid as multiple dose 200 mg/day DRUG

130 participants will receive CIR-NA (200 mg/d). Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.

Also known as: CIR-NA 200 mg

CIR-NA 200

controlled-ileal-release nicotinic acid as multiple dose placebo DRUG

130 participants will receive placebo. Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.

Also known as: Placebo

CIR-NA Placebo

controlled-ileal-release nicotinic acid as multiple dose 100 mg/day DRUG

130 participants will receive CIR-NA (100 mg/d). Additionally, all participants will receive standardized lifestyle recommendations regarding nutrition and physical activity.

Also known as: CIR-NA 100 mg

CIR-NA 100

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (2)

University Medical Center Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

University of Leipzig Medical Center

Leipzig, 04103, Germany

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Study Officials

• Matthias Laudes, Prof. Dr.

  University Medical Center Schleswig-Holstein, Campus Kiel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinna Geisler, PhD

CONTACT

+4943150022446; corinna.geisler@uksh.de

Matthias Laudes, Prof. Dr.

CONTACT

+49 431 500 22217; matthias.laudes@uksh.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)