Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOrsoBio, Inc
About this trial
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.
Eligibility criteria
Qualifiers
BMI ≥ 28 kg/m2 at Screening
Fasting TG ≥ 350 mg/dL
Subjects without diabetes or subjects with diabetes and HbA1c < 9.5% at Screening
Screening laboratory evaluations (eGFR, ALT, AST, INR, total bilirubin, platelet count) must fall within the protocol-defined ranges
Disqualifiers
HbA1c ≥ 9.5% at Screening
Weight loss > 5% during the 90 days prior to Screening
Pregnant or lactating subjects.
Current alcohol abuse that is judged by the investigator to potentially interfere with the subject's compliance or safety
Trial design
Treatments tested in this trial
- TLC-2716 Dose 1
- TLC-2716 Dose 2
- Placebo
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov