EUCTR2015-000493-35-DEActive, not recruitingPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Akcea Therapeutics, Inc.
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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