A Randomized, Double-Blind, Placebo-Controlled, with an Open Label Extension, Phase 2/3 Study of ISIS 304801 Administered Subcutaneously to Patients with Familial Partial Lipodystrophy - The BROADEN Study

Ionis Pharmaceuticals, Inc.0 个研究点目标入组 125 人开始时间: 2015年9月25日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Clinical diagnosis of FPL plus diagnosis of type 2 diabetes mellitus and hypertriglyceridemia.
•2. Diagnosis of type 2 diabetes mellitus as defined by the ADASMCD in 2015 made at least 12 weeks prior to the screening visit
•3. Hypertriglyceridemia is defined as Fasting TG = 500 mg/dL (5.7 mmol/L) at Screening and qualification visit.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 47
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•1. A diagnosis of generalized lipodystrophy
•2. A diagnosis of acquired partial lipodystrophy (APL)
•3. Acute pancreatitis within 4 weeks of Screening
•4. History within 6 months of Screening of acute or unstable cardiac ischemia (myocardial infarction, acute coronary syndrome, new onset angina), stroke, transient ischemic attack or unstable congestive heart failure requiring a change in medication
•5. Major surgery within 3 months of Screening
•6. Platelet count < lower limit of normal
•7. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in our completing the study

发起方