NCT05256979 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ampuero J, Gallego-Duran R, Romero-Gomez M
Association of NAFLD with subclinical atherosclerosis and coronary-artery disease: meta-analysis. Rev Esp Enferm Dig. 2015 Jan;107(1):10-6.
Ratziu V, de Ledinghen V, Oberti F, Mathurin P, Wartelle-Bladou C, Renou C, Sogni P, Maynard M, Larrey D, Serfaty L, Bonnefont-Rousselot D, Bastard JP, Riviere M, Spenard J; FRESGUN
A randomized controlled trial of high-dose ursodesoxycholic acid for non
Sanchez-Garcia A, Sahebkar A, Simental-Mendia M, Simental-Mendia LE
Effect of ursodeoxycholic acid on glycemic markers: A systematic review and meta-analysis of clinical trials. Pharmacol Res. 2018 Sep;135:144-149. doi: 10.1016/j.phrs.2018.08.008. Epub 2018 Aug 9.
Vitek L
Bile Acids in the Treatment of Cardiometabolic Diseases. Ann Hepatol. 2017 Nov;16(Suppl. 1: s3-105.):s43-s52. doi: 10.5604/01.3001.0010.5496.

Clinical Observation of the Effect of Ursodeoxycholic Acid on Parameters Affecting Liver, Metabolic and Cardiovascular Morbidity and Mortality - Pilot Project

Details for clinical trial NCT05256979

Clinical trial NCT05256979 - References