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

NCT06564584 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-03

No results posted yet for this study

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.

Conditions

  • Hypertriglyceridemia
  • Nonalcoholic Fatty Liver Disease

Interventions

DRUG

TLC-2716 Dose 1

Capsules administered orally

DRUG

TLC-2716 Dose 2

Capsules administered orally

DRUG

Placebo

Capsules administered orally

Sponsors & Collaborators

  • OrsoBio, Inc

    lead INDUSTRY

Principal Investigators

  • OrsoBio Study Director · OrsoBio, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-12
Primary Completion
2025-06-30
Completion
2025-09-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06564584 on ClinicalTrials.gov