RECRUITINGPhase 2INTERVENTIONAL
A Mechanistic Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of MAR001 on Postprandial Lipids in Patients With Elevated Triglycerides and Remnant Cholesterol
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Willingness to provide willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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 weakened immune system virus (HIV) infection
- Uncontrolled hypothyroidism
- Any condition that prevents the participant from complying with study procedures
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
MAR001
Subcutaneous Injection
DRUG
Placebo
Subcutaneous Injection
Locations (1)
Marea Site 301
Chula Vista, California, United States