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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TLC-2716 Dose 1
DrugCapsules administered orally
TLC-2716 Dose 2
DrugCapsules administered orally
Placebo
DrugCapsules administered orally
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: TLC-2716 Dose 1Experimental treatment 1 intervention
Group B: TLC-2716 Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in fasting triglycerides
Relative (%) change in fasting triglycerides at Week 4 from baseline
Time frame
Through study completion, up to Day 28 of the study2
Incidence of TLC-2716 treatment-emergent adverse events
Adverse events (AEs) - severity of the AEs will be graded using the Common Terminology Criteria for AE (CTCAE) (v5.0). The relationship between AEs and the study drug will be indicated as related or not related.
Time frame
Through study completion, up to Day 28 of the studySponsors and contacts
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Source ClinicalTrials.gov