A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Recruiting · NCT07199309 · Interventional (participants receive a specific treatment) · Lead sponsor: Marea Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
MAR001Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Stable drug regimen (appropriate if relevant) prior to screening visit and no planned changes during screening or trial participation
Exclusion criteria
- Acute or chronic liver disease
- Diabetes medications (other than metformin)
- History of type 1 diabetes mellitus or history of diabetic ketoacidosis
- Newly diagnosed T2DM
- Participants with known active hepatitis A, B, or C
- Participants who are known to have uncontrolled human immunodeficiency virus (HIV) infection
- Uncontrolled hypothyroidism
- Any condition that prevents the participant from complying with study procedures
Where it is running
1 location listed across 1 US state.
- Marea Site 301 - Chula Vista, California, United States