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Recruiting NCT07028749

Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol

Phase II Interventional Hypertriglyceridemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MAR001, Placebo.
Who it may be relevant to
Registry conditions: Hypertriglyceridemia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 2b Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of MAR001 in Patients With Elevated Triglycerides and Remnant Cholesterol (TYDAL-TIMI 78)

Overview

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

Detailed description

MAR-103 is a randomized, double-blind, parallel-group, placebo-controlled study with two parts (Part A and Part B).

In both Part A and Part B, participants will be randomized at Day 1. The study will include a screening period (up to 8 weeks), a 24-week treatment period, and a 12-week safety follow-up period. The 12-week safety follow-up period will include 2 clinic visits at Week 28 and Week 36 (End of Study).

Part A: Approximately 216 participants with baseline TG between 150 to 880 mg/dL will be enrolled in Part A at a 3:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). Three doses of MAR001 will be administered.

Part B: Approximately 100 participants with baseline TG between 450 and 2000 mg/dL will be enrolled in Part B at a 1:1 ratio of MAR001 to placebo for dosing every 4 weeks (Q4W). The MAR001 dose will be within the range tested during Part A and will be selected based on emerging Part A data.

Interventions

  • Drug MAR001
    Subcutaneous Injection
  • Drug Placebo
    Subcutaneous injection

Primary outcome measures

  • Primary Endpoint [Time frame: 12 weeks]
Secondary outcome measures (4)
  • Secondary Endpoint [Time frame: 12 weeks]
  • Secondary Endpoint [Time frame: 12 weeks]
  • Secondary Endpoint [Time frame: 16 weeks]
  • Secondary Endpoint [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • Elevated fasting TGs and RC
  • Elevated nonfasting TGs and RC
  • Part A only: 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 during screening or trial participation
  • Stable drug regimen (if relevant) prior to screening visit and no planned changes after enrollment; Part B only: adjustment of lipid-lowering therapy during the diet/lifestyle run-in period is permitted

Exclusion criteria

  • Acute or chronic liver disease
  • Part A only: TG concentration ≥880mg/dl; Part B only: TG concentration ≥2000 mg/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
  • Part B only: recent history of active pancreatitis
  • Part B only: genetically confirmed Familial Chylomicronemia Syndrome (FCS) diagnosis due to biallelic loss of function mutations in LPL or GPIHBP1
  • Part B only: use of ANGPTL3 and ApoC-III inhibitors
  • Any condition that prevents the participant from complying with study procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • Marea Site 328 — Anniston
  • Marea Site 329 — Mobile
  • Marea Site 313 — Little Rock
  • Marea Site 306 — Hamden
  • Marea Site 302 — Boca Raton
  • Marea Site 307 — Port Saint Lucie
  • Marea Site 310 — Columbus
  • Marea Site 319 — Peachtree Corners
  • … and 18 more centers
Australia · 13 centers
  • Marea Site 103 — Canberra
  • Marea Site 105 — Kanwal
  • Marea Site 107 — Merewether
  • Marea Site 106 — Miranda
  • Marea Site 109 — Wollongong
  • Marea Site 108 — Herston
  • Marea Site 104 — Milton
  • Marea Site 111 — Leabrook
  • … and 5 more centers
New Zealand · 8 centers
  • Marea Site 211 — Birkenhead
  • Marea Site 207 — New Lynn
  • Marea Site 203 — Papatoetoe
  • Marea Site 205 — Silverdale
  • Marea Site 206 — Christchurch
  • Marea Site 204 — Ebdentown
  • Marea Site 209 — Christchurch
  • Marea Site 208 — Rotorua
Canada · 7 centers
  • Marea Site 406 — Concord
  • Marea Site 403 — London
  • Marea Site 404 — Sarnia
  • Marea Site 401 — Chicoutimi
  • Marea Site 402 — Montreal
  • Marea Site 405 — Québec
  • Marea Site 407 — Québec

Identifiers

NCT: NCT07028749 · MAR-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗