TGAB

• Research type

  Research Study

• Full title

  Study of the Safety and Efficacy of LY3016859 after Multiple Intravenous Dosing in Diabetic Nephropathy Patients

• IRAS ID

  121852

• Contact name

  Aliya Asher

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2012-004496-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  We are conducting a multi-centre clinical trial in the UK and abroad to test a potential new medicine known as LY3016859 (LY) in patients suffering from diabetic nephropathy (DN). It is anticipated that LY will stop orislow down disease progression; a measure of which is decreased proteinuria (leakage of protein from blood into urine which occurs in renal diseases such as DN). The current treatments for DN include angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (areas). Although both ACE inhibitors and areas provide some renal benefit, they do not prevent a decline in kidney function or progression to renal failure and they also have considerable undesirable side-effects. Consequently, new therapies are urgently needed. In this study we will collect information on safety and tolerability of intravenous (IV) infusion doses of LY in patients with DN as well as its effect on proteinuria and other biomarkers. The study will be carried out in 2 parts using a randomized, double-blind, multiple-ascending-dose (MAD) (Part A) and randomized double-blind multiple parallel-dose proof of concept (POC) (Part B) study design. The standard procedures for the study include safety laboratory tests on blood and urine samples, vital signs, physical examination, electrocardiograms (ECG), pharmacokinetics (assessment of LY levels in the blood) pharmacodynamics (proteinuria measurements) and immunogenicity (detection of antidrug antibodies). An optional blood sample will also be taken for genetic testing if the volunteer gives their consent for genetic testing.The study will last for approximately 18 weeks or 31 weeks for each volunteer including the time when we determine who is suitable for taking part in the study. Although patients who receive LY may potentially have a beneficial effect, it is not certain as this is a medication and the treatment is for a short time only. All volunteers will be compensated for their time.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0005

• Date of REC Opinion

  15 Feb 2013

• REC opinion

  Further Information Favourable Opinion