Clinical Trials Logo
  1. Home
  2. Hypertriglyceridemia
  3. NCT05896254
  4. Details
NCT05896254 Clinical Trial

Study of MAR001 in Adults With Metabolic Dysfunction

Hypertriglyceridemia Clinical Trial

Official title:
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05896254
Other study ID # MAR-102
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 22, 2023
Est. completion date November 2024

Study information
Verified date March 2024
Source Marea Therapeutics
Contact Jennifer Tam
Phone 415-766-3610
Email jtam@mareatx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date November 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MAR001
Subcutaneous injection
• Placebo
Subcutaneous injection

Locations
Country Name City State
Australia Brisbane Site Brisbane
Australia Melbourne Site Melbourne

Sponsors (1)
Lead Sponsor Collaborator
Marea Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability of MAR001 Incidence and frequency of treatment-emergent adverse events 12 weeks
Secondary Effect of MAR001 on triglyceride metabolism Change from baseline in triglyceride levels 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Completed NCT02250105 - Trial of ARI-3037MO to Reduce Triglyceride Levels in Adults With Severe (≥500 mg/dl) Hypertriglyceridemia Phase 2
Completed NCT02859129 - Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®) Phase 1
Completed NCT01455844 - TRIal For Efficacy of Capre on hyperTriglyceridemiA Phase 2
Completed NCT01437930 - Intervention With n-3 Polyunsaturated Fatty Acids (PUFA)-Supplemented Products in Moderate Hypertriglyceridemic Patients N/A
Completed NCT01010399 - Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects Phase 4
Completed NCT00959842 - Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia Phase 1/Phase 2
Completed NCT00519714 - A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA) Phase 2/Phase 3
Recruiting NCT00186537 - Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. N/A
Completed NCT00246402 - Acipimox to Improve Hyperlipidemia and Insulin Sensitivity Associated With HIV N/A
Completed NCT06020950 - Chia Seeds Consumption in Hypertriglyceridemia N/A
Completed NCT02354976 - A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects. Phase 2
Completed NCT04966494 - Impact of Beans and Oats Snack Bar on Hypertriglyceridemic Women N/A
Completed NCT04650152 - Study to Assess Tricor Therapy Effectiveness in Patients With Metabolic Syndrome (TRISTAN)
Completed NCT04630366 - A Phase 1, First Time in Humans Study of NST-1024 Phase 1
Completed NCT03693131 - Efficacy of MND-2119 in Participants With Hypertriglyceridemia Phase 3
Completed NCT04756180 - An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia. Phase 3
Completed NCT02868177 - Effect of Totum-63, Active Ingredient of Valedia, on Glucose and Lipid Homeostasis on Subjects With Prediabetes Phase 2/Phase 3
Completed NCT01968720 - Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia Phase 2
Completed NCT01462877 - A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic Phase 4