Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

Marea Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: MAR001; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07028749

MAR-103

Details and patient eligibility

About

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

Enrollment: 216 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated fasting TGs and RC
• Elevated nonfasting TGs and RC
• 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
• 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 (if relevant) prior to screening visit and no planned changes during screening or trial participation

Exclusion criteria

• Acute or chronic liver disease
• TG concentration ≥880mg/dl
• History of type 1 diabetes mellitus or history of diabetic ketoacidosis
• Newly diagnosed T2DM
• Participants with known active hepatitis A, B, or C
• Uncontrolled hypothyroidism
• Any condition that prevents the participant from complying with study procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 3 patient groups

MAR001 Dose 1

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Placebo

Drug: MAR001

MAR001 Dose 2

Experimental group

Description:

Subcutaneous Injection

Treatment:

Drug: Placebo

Drug: MAR001

MAR001 Dose 3

Experimental group

Description:

Subcutaneous Injection

Treatment:

Drug: Placebo

Drug: MAR001