MUIR-3Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Hypertriglyceridemia
Plozasiran Injection
+ Placebo
Hyperlipidemias+3
+ Metabolic Diseases
+ Nutritional and Metabolic Diseases
Treatment Study
Summary
Study start date: May 21, 2024
Actual date on which the first participant was enrolled.The study aims to test a new treatment called plozasiran for adults who have high levels of triglycerides in their blood, a condition known as hypertriglyceridemia. This condition can increase the risk of heart disease and other health problems. The study hopes to determine if plozasiran can effectively lower triglyceride levels and improve health outcomes for these individuals. Understanding the effectiveness and safety of this treatment could lead to better management of hypertriglyceridemia, offering a new option for those who struggle with controlling their triglyceride levels through existing treatments. Participants in the study will be randomly divided into two groups. One group will receive injections of plozasiran, while the other group will receive a placebo, which is an inactive substance, to compare the effects. Each participant will receive four injections, once every three months. Throughout the study, researchers will closely monitor the participants to assess the treatment's effectiveness in reducing triglyceride levels and to ensure the safety of the participants. This thorough evaluation will help determine if plozasiran is a viable treatment option for hypertriglyceridemia.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1456 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Males, or nonpregnant (who do not plan to become pregnant) nonlactating females, who are ≥18 years of age at screening * Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L) * Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period * Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening * Screening HbA1c ≤9.0% * Willing to follow diet counseling and maintain a stable low-fat diet * Must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due a previous adverse reaction associated with, attributed to, or caused by specific drug) prior to collection of qualifying TG levels. Exclusion Criteria: * Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks. * Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer * Acute pancreatitis within 4 weeks prior to screening * Body mass index \>45 kg/m\^2 Note: Additional Inclusion/Exclusion criteria may apply per protocol
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 235 locations
Research Site 2
Mobile, United StatesResearch Site 3
Beverly Hills, United StatesResearch Site 4
Canoga Park, United States