Actively Recruiting
Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
Led by OrsoBio, Inc · Updated on 2025-04-03
30
Participants Needed
4
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI of 28 kg/m2 or higher at Screening
- Fasting triglycerides of 350 mg/dL or higher
- Subjects without diabetes or with diabetes and HbA1c less than 9.5% at Screening
- Screening lab results (eGFR, ALT, AST, INR, total bilirubin, platelet count) within protocol-defined ranges
- Clinical diagnosis of NAFLD/NASH within 5 years based on imaging or liver biopsy, with no weight loss greater than 5% since diagnosis
- Normotensive or controlled blood pressure (systolic ≤ 155 mmHg and diastolic ≤ 90 mmHg)
- Normal or not clinically significant 12-lead ECG at Screening
- Female subjects of childbearing potential must have negative pregnancy tests at Screening and Day 1
- Male and female subjects of childbearing potential must agree to use specified contraception methods
You will not qualify if you...
- HbA1c of 9.5% or higher at Screening
- Weight loss greater than 5% in the 90 days before Screening
- Pregnant or lactating subjects
- Current alcohol or substance abuse judged to interfere with compliance or safety
- Positive test for HIV-1, hepatitis B, or hepatitis C
- History of liver diseases other than NAFLD/NASH, including alcoholic liver disease, autoimmune disorders, drug-induced liver injury, Wilson disease, iron overload, or alpha-1-antitrypsin deficiency
- History of cirrhosis or decompensated liver disease
- Unstable cardiovascular disease
- History of intestinal resection or malabsorptive conditions affecting drug absorption (except appendectomy or cholecystectomy)
- Severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions
- Scheduled surgery during study (excluding minor local procedures)
- History of malignancy within 5 years except certain treated cancers
- History of significant drug allergy or hypersensitivity to study drug or its components
- Any medical condition or psychiatric disorder that could affect study participation
- Any lab abnormalities that could affect safety or study assessments
- Use of weight loss medications or therapies within 90 days before Screening
- Receipt of COVID-19 or any live vaccine within 14 days before planned dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
OrsoBio Research Site
Guadalajara, Jalisco, Mexico, 45116
Actively Recruiting
2
OrsoBio Research Site
Zapopan, Jalisco, Mexico, 45170
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3
OrsoBio Research Site
Mexico City, Mexico City, Mexico, 06700
Actively Recruiting
4
OrsoBio Research Site
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
R
Ryan Huss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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