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A trial to evaluate the efficacy and safety of oral controlled-ileal-release nicotinic acid (CIR-NA) for inducing remission in subjects with prediabetes
EU CTIS ID: 2024-519903-88-00
What this study is testing
The primary objective is to assess the efficacy of CIR-NA on the remission of prediabetes at week 26.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.