Phase 2
Completed N=10
The Role of TLR4 on Lipid-induced Insulin Resistance
Insulin Sensitivity
Source: ClinicalTrials.gov NCT02321111 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Effect of Eritoran on Muscle Insulin Sensitivity — 11.9; 10.2; 9.8 mg/kg/min — p=0.02
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Eritoran on Muscle Insulin Sensitivity |
11.9; 10.2; 9.8 | 0.02 sig |
| PRIMARY Effect of Eritoran on Hepatic Insulin Sensitivity |
2.2; 2.3; 2.2 | — |
| SECONDARY Effect of Eritoran on TLR4 Expression on Peripheral Blood Monocytes |
1.1; 1.2; 1.1 | — |
| SECONDARY Effect of Eritoran on Plasma Cytokine Concentration |
1.6; 2.0; 2.0 | — |
| SECONDARY Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects capable of giving informed consent.
- lean (BMI =6 months.
- Lab: Hematocrit >=34%, serum creatinine =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.
Data sourced from ClinicalTrials.gov (NCT02321111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.