Expired Study
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San Antonio, Texas 78229


The purpose of this study is to determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran for injection (E5564) prevents lipid-induced insulin resistance in lean, normal glucose tolerant (NGT) subjects.

Study summary:

E5564 = Eritoran


Inclusion Criteria: - Subjects capable of giving informed consent. - lean (BMI <26 kg/m2) - normal glucose-tolerant subjects (completers) without a family history of Type 2 diabetes mellitus (DM) - Both genders. (50% males) - Age = 18-65 years. Older subjects are excluded because aging is a pro-inflammatory state. - All ethnic groups - Premenopausal women in the follicular phase, non-lactating, and with a negative pregnancy test. Postmenopausal women on stable dose of or not exposed to hormone replacement for >=6 months. - Lab: Hematocrit >=34%, serum creatinine <=1.4 mg/dL, normal electrolytes, urinalysis, and coagulation tests. Liver function tests up to 2x normal range. - Stable body weight (+/-1%) for >=3 months. - One or less sessions of strenuous exercise/wk for last 6 months. Exclusion Criteria: - Presence of diabetes or impaired glucose tolerance based on ADA criteria; - Current treatment with drugs known to affect glucose and lipid homeostasis. Subjects on a stable dose of statin (>3months) are eligible. - Non-steroidal anti-inflammatory drugs or systemic steroid use for more than 1 week within 3 months. - Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies. - History of heart disease (New York Heart Classification greater than class II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, pulmonary disease, smokers. - Poorly controlled blood pressure (systolic BP>160, diastolic BP>90 mmHg). - Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease.



Primary Contact:

Principal Investigator
Nicolas Musi, MD
The University of Texas Health Science Center at San Antonio

Backup Contact:


Location Contact:

San Antonio, Texas 78229
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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