None listed
Conditions
Brief summary
- This study will test the safety of MAR005 in people with Elevated triglyceride levels. - Up to 10 participants will receive two injections of MAR005, - Participants will attend clinic visits for health checks, study assessments, and monitoring. - The study will also assess how the body responds to and processes MAR005 over time.
Interventions
Up to 10 participants with high triglycerides will be receiving MAR005.
MAR005 is a monoclonal antibody designed to block angiopoietin-like 4.
Investigational product: 300 mg dose of MAR005 for subcutaneous (SC) injection administered by site staff on Day 1 and Day 29.
Participants will be screened within 42 days before their first dose of trial intervention and will attend the Clinical Unit for 2 screening visits, separated by at least 7 days.
They will attend the Clinical Unit for outpa
Up to 10 participants with high triglycerides will be receiving MAR005. MAR005 is a monoclonal antibody designed to block angiopoietin-like 4. Investigational product: 300 mg dose of MAR005 for subcutaneous (SC) injection administered by site staff on Day 1 and Day 29. Participants will be screened within 42 days before their first dose of trial intervention and will attend the Clinical Unit for 2 screening visits, separated by at least 7 days. They will attend the Clinical Unit for outpatient dosing visits, remaining in the Clinical Unit until at least 6 h after dosing. Participants will be evaluated for safety throughout the trial and will attend the Clinical Unit for 11 additional outpatient visits Adherence to the intervention will be monitored through direct administration of all doses by qualified study personnel at the Clinical Research Unit. Dosing will be documented in source records and drug accountability records, and participants will be monitored according to the protocol-defined schedule.
Sponsors
Marea Therapeutics, Inc.
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Fasting triglycerides (TG) value more than or equal to 150 mg/dL at both screening visits 1 and 2 (separated by at least 7 days) 2. Stable drug regimen (if relevant) prior to first screening visit and no planned changes during screening or trial participation. A stable drug regimen is defined as use of any of the following medications at a stable dose for at least the duration specified below: • Lipid-lowering therapies > 4 weeks • Beta-blockers, thiazide diuretics > 4 weeks • Diabetes mellitus medications (except glucagon-like peptide-1 [GLP-1] or dual-acting GLP-1/glucose-dependent insulinotropic polypeptide [GIP] receptor agonists) > 4 weeks • GLP-1 or dual-acting GLP-1/GIP receptor agonists > 12 weeks • Atypical antipsychotics > 12 weeks • Systemic estrogens, tamoxifen, raloxifene > 16 weeks 3. Body weight more than or equal to 50 kg. 4. Negative pregnancy test at screening and admission (female participants only).
Exclusion criteria
1. History of Type 1 Diabetes Mellitus (T1DM) or history of Diabetic Ketoacidosis (DKA). 2. Poorly controlled Type 2 Diabetes Mellitus (T2DM) with HbA1c more than or equal to 8.0% at screening. 3. Newly diagnosed T2DM (within 6 months of randomization) or laboratory evidence of T2DM during screening (fasting HbA1c more than or equal to 6.5%) without prior diagnosis). 4. Uncontrolled hypertension (blood pressure > 150/90 mm Hg) at either of the 2 screening visits. 5. Current heavy smoker (> 10 cigarettes per day) or equivalent use of any other nicotine product, and/or unwilling to abstain from smoking or using other nicotine products during dosing visits. 6. Use of/unable to refrain from using Angiopoietin-like Protein 3 (ANGPTL3) or Apolipoprotein C-III (ApoC-III) inhibitors (e.g. olezarsen and plozasiran), from 12 months before screening until the end of the trial. 7. Clinically relevant abnormal history, physical findings, ECG, vital signs, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the participant. 8. History of anaphylaxis or other significant allergy in the opinion of the Investigator. 9. Use of any monoclonal antibody therapy in the 6 months before screening, or history of hypersensitivity to any monoclonal antibody, or to any of the excipients used in the trial interventions 10 History of cancer within 3 years of screening 11. Positive test for HIV antibody, hepatitis B surface antigen, or hepatitis C antibody.
Outcome results
None listed