NCT06564584

Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD

A Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: OrsoBio, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Participation in the study can last up to approximately 10 weeks, including a 4 week Screening period, a 4-week treatment period during which study drugs will be administered, and a 2-week follow-up period.

Conditions

• Hypertriglyceridemia
• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	TLC-2716 Dose 1	Capsules administered orally
DRUG	TLC-2716 Dose 2	Capsules administered orally
DRUG	Placebo	Capsules administered orally

Timeline

• Start date: 2024-08-12
• Primary completion: 2025-06-01
• Completion: 2025-09-01
• First posted: 2024-08-21
• Last updated: 2025-04-03

Locations

4 sites across 1 country: Mexico