- 6/17/17 Monday 11:30AM Eli Lilly: New data showed LIVALO (pitavastatin) 4 mg had neutral effects on fasting serum glucose and HbA1c levels in HIV-infected adults with dyslipidemia (LLY) 52.65 +0.59 : Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company (LLY) announced results of a pre-specified safety analysis from the INTREPID (HIV-infected patieNts and TREatment with PItavastatin vs. pravastatin for Dyslipidemia) trial evaluating the effect of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg on changes in levels of blood glucose and glycated hemoglobin (HbA1c) in HIV-infected adults with dyslipidemia. INTREPID was a Phase 4, multicenter, 12-week randomized superiority study followed by a 40-week safety extension study (NCT01301066) comparing the lipid-lowering effects of pitavastatin 4 mg and pravastatin 40 mg in adults with HIV infection and dyslipidemia. The results of this pre-specified safety analysis, presented yesterday at the Endocrine Society's 95th Annual Meeting & Expo in San Francisco, CA, showed neutral effects of pitavastatin 4 mg and pravastatin 40 mg on fasting serum glucose (FSG) and HbA1c levels over 12 weeks. By week 12, the mean change in FSG for pitavastatin (n=109) was -0.1mg/dL and pravastatin (n=112) was 0.6 mg/dL, and the adjusted (least squares mean) change in FSG was 0.6 mg/dL for pitavastatin and 2.5 mg/dL for pravastatin with no significant differences in each treatment group (p=0.68 and 0.09, respectively). There was no significant difference between treatment groups (p=0.20).
- 6/13/13 4:40PM : Eli Lilly voluntarily terminates Phase 2 study for LY2886721, a beta secretase inhibitor, being investigated as a treatment for Alzheimer's Disease (LLY) 51.85 +0.07 : Co announced it has stopped its Phase II study (BACC) for LY2886721, a beta secretase (BACE) inhibitor being investigated as a once daily treatment for its potential to slow the progression of Alzheimer's disease. The decision to terminate the study was due to abnormal liver biochemical tests. Clinical study investigators have been notified. The cases of abnormal liver biochemical tests were identified as part of routine monitoring. Lilly will continue to monitor all participants with abnormal liver biochemical tests. Based on the information Lilly has today, it believes that the abnormal liver biochemical tests observed in this study are not related to the BACE mechanism and continues to be interested in developing BACE inhibitors for the benefit of patients with Alzheimer's disease. Lilly will further evaluate this data prior to determining next steps for the entire LY2886721 clinical development program. The company expects to incur a financial charge associated with the decision to stop this trial. However, the amount of this charge is not expected to be material and is not expected to result in a change to the company's previously-issued 2013 financial guidance.
Tuesday, June 18, 2013
Eli Lilly (LLY) - news
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