NCT02267317: Eritoran2

Phase 2 Study of The Role of Pharmacologic Inhibition of TLR4 With E5564 on Glucose Metabolism in Insulin Resistant Subjects.

Terminated Phase 2 Results posted Last updated 24 February 2020

What this trial tests

Phase 2 trial testing Eritoran in Insulin Sensitivity in 15 participants. Terminated before completion.

Timeline

1 January 2015

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	1 January 2015
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Eritoran — full drug profile →
• D5W

Conditions studied

• Insulin Sensitivity — all drugs for Insulin Sensitivity →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 18 to 65, any sex, with Insulin Sensitivity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Effect of Eritoran on Muscle Insulin Sensitivity
  Time frame: 72 hours
  Muscle insulin sensitivity = muscle insulin sensitivity is determined by euglycemic hyperinsulinemic clamp procedure. M value (mg glucose / kg of body weight / minute) calculated from the clamp is measured. Higher M value indicates better insulin sensitivity. There is no established reference range.
• Effect of Eritoran on Hepatic Insulin Sensitivity
  Time frame: 72 hours
  Hepatic insulin sensitivity = is determined by euglycemic hyperinsulinemic clamp procedure. Endogenous glucose production or EGP (mg/kg/min) calculated from the clamp is measured. Lower EGP indicates better hepatic insulin sensitivity. There is no established reference range.

Sponsor's own description

To determine whether pharmacologic inhibition of Toll-like receptor 4 (TLR4) with eritoran for injection (E5564) will reduce inflammation and improve glucose metabolism in insulin resistant (obese and T2DM) subjects.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent clinical trends in Toll-like receptor targeting therapeutics.
   Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553
2. Toll-Like Receptors as a Therapeutic Target in the Era of Immunotherapies.
   Farooq M, Batool M, Kim MS, Choi S. · · 2021 · cited 70× · PMID 34671606 · DOI 10.3389/fcell.2021.756315
3. Pattern recognition receptors: function, regulation and therapeutic potential.
   Chen R, Zou J, Chen J, Zhong X, et al · · 2025 · cited 53× · PMID 40640149 · DOI 10.1038/s41392-025-02264-1
4. Targeting toll-like receptor 4 signalling pathways: can therapeutics pay the toll for hypertension?
   Nunes KP, de Oliveira AA, Mowry FE, Biancardi VC. · · 2019 · cited 46× · PMID 29981161 · DOI 10.1111/bph.14438
5. Pattern Recognition Receptor-Mediated Chronic Inflammation in the Development and Progression of Obesity-Related Metabolic Diseases.
   Yu L, Li Y, Du C, Zhao W, et al · · 2019 · cited 33× · PMID 31582899 · DOI 10.1155/2019/5271295
6. Effect of acute TLR4 inhibition on insulin resistance in humans.
   Liang H, Sathavarodom N, Colmenares C, Gelfond J, et al · · 2022 · cited 15× · PMID 36066991 · DOI 10.1172/jci162291