Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
🩺 Protocol Summary
This is a Phase 2a, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides, liver steatosis by MRI, and other biomarkers.
Primary Research Facility: OrsoBio Research Site (Guadalajara, Jalisco)
📋 Basic Study Criteria & Logistics Checklist
0 of 3 CheckedReview these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).
📍 Primary Site Map
Site: OrsoBio Research Site — Guadalajara, Jalisco
📍 All Participating Trial Locations (4 Sites)
Multi-Center TrialThis protocol is enrolling participants across multiple clinical centers:
📄 Print Doctor Discussion Sheet
Preview and print a 1-page summary with 5 tailored questions for your physician.
💰 Clinical Trial Costs & Insurance Coverage
Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.
💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.