To evaluate the safety of ISIS 484137 on Hepatic Steatosis in T2D
Research type
Research Study
Full title
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Pharmacodynamics of ISIS 484137 (ISIS-DGAT2RX, an Antisense Inhibitor of Diacylglycerol Acyltransferase 2) Administered Once-Weekly for 13 Weeks on Hepatic Steatosis in Adult Patients with Type 2 Diabetes
IRAS ID
235834
Contact name
Guruprasad Aithal
Contact email
Sponsor organisation
Ionis Pharmaceuticals, Inc.
Eudract number
2017-003197-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 0 days
Research summary
The purpose of this research study is to evaluate the effect and safety of 13 weeks of treatment with 250 mg/week sub-cutaneous injections of ISIS 484137 on the amount of liver fat in type 2 diabetes (T2DM) patients who are currently taking oral medications for their diabetes. The study medication, ISIS 484137, is being compared to placebo (a salt solution). A placebo looks like the study medication but does not contain the study medication’s active ingredient.
Treatment with ISIS 484137 in animals has been shown to reduce the production of a protein that is involved in fat production thus decreasing liver fat. The intended effect of ISIS 484137 is to reduce the build-up of fat in the liver in humans. It is not yet known whether ISIS 484137 is effective in humans. ISIS 484137 is not commercially available and is not approved for sale anywhere in the world. ISIS 484137 is only approved for use in research studies like this one. The suggested dose of 250 mg of ISIS 484137 was selected for this study based on the results of the Phase 1 trial ISIS 484137-CS1 which demonstrated an acceptable safety and tolerability profile for doses up to 300 mg after 6 weeks of treatment in 40 healthy overweight subjects.
This study will last for approximately 8 months, including the screening period and will include up to 22 doctor visits to the clinic and 2 visits to a magnetic resonance imaging (MRI) facility. The MRI is a non-invasive (does not break the skin) procedure and will measure the amount of fat in the patients liver. Patients will have to agree to take part in the MRI procedures as part of the informed consent process, MRI scans will be performed during the run-in period and post-treatment at the end of the study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
17/EM/0467
Date of REC Opinion
6 Apr 2018
REC opinion
Further Information Favourable Opinion