Health TrialsbyHealthPanel

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

ConditionHypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMarea Therapeutics

About this trial

The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of TG in adults with elevated TG and RC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elevated fasting TGs and RC

Elevated nonfasting TGs and RC

Part A only: Fasting LDL-C ≥ 50 mg/dL (≥ 1.29 mmol/L) and ≤ 130 mg/dL (≤ 3.36 mmol/L)

Willingness to provide informed consent and comply with the intervention and all study assessments

Disqualifiers

Acute or chronic liver disease

Part A only: TG concentration ≥880mg/dl; Part B only: TG concentration ≥2000 mg/dL

History of type 1 diabetes mellitus or history of diabetic ketoacidosis

Newly diagnosed T2DM

Trial design

Design model

Parallel

Treatments tested in this trial

  • MAR001

    Drug

    Subcutaneous Injection

  • Placebo

    Drug

    Subcutaneous injection

Treatment groups

316 Participants
are divided into 4 treatment groups
Group A: MAR001 Dose 1 (Part A)Experimental treatment 2 interventions
Group B: MAR001 Dose 2 (Part A)Experimental treatment 2 interventions
Group C: MAR001 Dose 3 (Part A)Experimental treatment 2 interventions
Group D: MAR001 Dose 4 (Part B)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Primary Endpoint

Percent change from baseline at Week 12 in fasting TG compared to placebo

Time frame
12 weeks

Secondary outcomes

1

Secondary Endpoint

Proportion of participants with Part A: baseline TG ≥150 mg/dL achieving TG \<150 mg/dL at Week 12 compared to placebo Part B: baseline TG ≥500 mg/dL achieving TG \<500 mg/dL at Week 12 compared to placebo

Time frame
12 weeks
2

Secondary Endpoint

Percent change from baseline at Week 12 in fasting RC compared to placebo

Time frame
12 weeks
3

Secondary Endpoint

Percent change from baseline at Week 16 in non-fasting TG compared to placebo

Time frame
16 weeks
4

Secondary Endpoint

Part A only: Percent change from baseline at Week 12 in fasting TG compared to placebo in participants with baseline TG ≥300 mg/dL

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marea Therapeutics

Lead sponsor

The TIMI Study Group

Collaborator

Source ClinicalTrials.gov
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