Study of ISIS 304801 versus placebo Administered Subcutaneously to Patients with Partial Lipodystrophy
- Conditions
- Partial lipodystrophyMedDRA version: 20.0Level: PTClassification code 10053857Term: Partial lipodystrophySystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2015-000493-35-DE
- Lead Sponsor
- Akcea Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Clinical diagnosis of FPL plus diagnosis of type 2 diabetes mellitus and
hypertriglyceridemia.
2. Diagnosis of Type 2 diabetes mellitus as defined by International Diabetes Federation guidelines made at least 6 months 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 57
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
7. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in our completing the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method