Study of MAR001 in Adults With Metabolic Dysfunction

Marea Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hypertriglyceridemia

Treatments: Drug: MAR001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05896254

MAR-102

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willingness to provide informed consent and comply with the intervention
• Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
• Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L)

Exclusion criteria

• Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
• Pregnant or breastfeeding mothers
• Terminal illness with expected survival of less than 1 year

Note: additional inclusion/exclusion criteria may apply, per protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

MAR001

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: MAR001

Placebo

Placebo Comparator group

Description:

Subcutaneous injection

Treatment:

Drug: Placebo