Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
390
Countries
1
Sites
2
Prediabetes
The primary objective is to assess the efficacy of CIR-NA on the remission of prediabetes at week 26.
Key facts
- Sponsor
- Universitaetsklinikum Schleswig-Holstein AöR
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 3 Mar 2026 → ongoing
- Decision date (initial)
- 2025-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
The primary objective is to assess the efficacy of CIR-NA on the remission of prediabetes at week 26.
Secondary objectives 1
- The secondary objectives are to assess the progression of prediabetes to T2DM and the individual levels of fasting plasma glucose (FPG), glycated haemoglobin (HbA1c) and the 2-h oral glucose tolerance test (oGTT) at week 26.
Conditions and MedDRA coding
Prediabetes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10065542 | Prediabetes | 10027433 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Male and female participants ≥ 18 to < 80 years of age
- Body mass index ≥ 20 kg/m²
- Diagnosed prediabetes according to the current EASD/DDG guidelines
Exclusion criteria 8
- Presence or a history of type 2 diabetes mellitus according to the current EASD/DDG guidelines
- 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
- Current or history of malignancy except for completely resected basal cell carcinoma and squamous cell carcinoma of the skin
- Use of antibiotics (systemic or gut-acting [non-absorbed]) within 8 weeks prior to the first dose of IMP
- Pregnant or breastfeeding women
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Remission of prediabetes at week 26
Secondary endpoints 4
- Progression of prediabetes to type 2 diabetes mellitus at week 26
- Fasting plasma glucose levels at week 26
- Glycated haemoglobin (HbA1c) levels at week 26
- 2-h oral Glucose Tolerance Test levels at week 26
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CIR-NA (controlled-ileal-release nicotinic acid)
PRD12320144 · Product
- Active substance
- Nicotinic Acid
- Substance synonyms
- VITAMIN PP, NIACIN, VITAMIN B3
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 37 g gram(s)
- Max treatment duration
- 185 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITY MEDICAL CENTER SCHLESWIG-HOLSTEIN (UKSH), CAMPUS KIEL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Schleswig-Holstein AöR
- Sponsor organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Address
- Arnold-Heller-Strasse 3, Brunswik Brunswik
- City
- Kiel
- Postcode
- 24105
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Contact name
- Office Prof. Stefan Schreiber
Public contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Contact name
- Office Prof. Stefan Schreiber
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 390 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Germany | 2026-03-03 | 2026-03-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-519903-88-00_p | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_2024-519903-88-00 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_description_2024-519903-88-00_A5_Flyer_Kiel_p | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_description_2024-519903-88-00_A5_Flyer_Leipzig_p | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_description_2024-519903-88-00_Faltflyer_Kiel_p | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_material_description_2024-519903-88-00_Faltflyer_Leipzig_p | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_adult_2024-519903-88-00_p | 3 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_adult_subgroup_2024-519903-88-00_p | 3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-12 | Germany | Acceptable with conditions 2025-08-18
|
2025-08-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-29 | Germany | Acceptable 2025-10-20
|
2025-10-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-20 | Germany | Acceptable 2026-01-26
|
2026-01-28 |