Safety And Efficacy Of Orally Administered DS102 In NAFLD Patients
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered DS102 In Patients with NAFLD
IRAS ID
205489
Contact name
Philip Newsome
Contact email
Sponsor organisation
Afimmune
Eudract number
2016-000311-33
Duration of Study in the UK
0 years, 11 months, 3 days
Research summary
This study will involve two dose levels of DS102 - 1000mg per day (500mg BD), 2000mg per day (1000mg BD) or placebo BD for 16 weeks using three treatment groups consisting of 23 patients each.
Patients with diagnosed NAFLD (Non Alcoholic Fatty Liver Disease) will be enrolled in the study. After assessment and documentation of the baseline disease characteristics by the investigator, the patient will be randomly assigned to one of the above mentioned treatment groups. The patient will be provided with study medication containing one of the assigned doses of DS102 or placebo according to the randomisation. During the 16 weeks of treatment patients will take one of the treatments twice daily with or after food (morning and evening).
Evaluation of efficacy will be performed throughout the study. A follow-up visit will be performed 4 weeks after the last date of treatment to monitor the treatment effects in comparison to the end of treatment.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0312
Date of REC Opinion
19 Aug 2016
REC opinion
Further Information Favourable Opinion