Health TrialsbyHealthPanel

A Mechanistic 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 determine the effect of MAR001 as compared to placebo on levels of the triglycerides (TG) in the postprandial state in adults with elevated TG.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Two fasting TG collected at two separate, consecutive visits at least 7 days apart during the Screening period

HbA1c ≥ 5.7% and ≤ 8.5%

Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study

Disqualifiers

Acute or chronic liver disease

Diabetes medications (other than metformin)

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

30 Participants
are divided into 2 treatment groups
Group A: MAR001 DoseExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in TG area under the curve after a mixed meal

Time frame
12 weeks
2

Change from baseline in peak plasma TG concentration after a mixed meal

Time frame
12 weeks

Secondary outcomes

1

Change from baseline in RC area under the curve after a mixed meal

Time frame
12 weeks
2

Change from baseline in peak plasma RC concentration after a mixed meal

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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

Marea Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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