Suspended

An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

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What is being tested

Data Collection

Who is being recruted

Hyperlipidemias
+2

+ Metabolic Diseases
+ Hypertriglyceridemia
From 8 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorMedical Research Laboratories International
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2004Actual date on which the first participant was enrolled.

The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.

Official TitleAn Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy 
NCT00080132
Principal SponsorMedical Research Laboratories International
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 8 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hyperlipidemias
Metabolic Diseases
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Criteria

Inclusion Criteria: In order to participate in this study, patients must meet all of the following inclusion criteria: * be between 8 and 70 years old with diagnosis of Fredrickson Type I or V HTG * be stable on current maximum tolerated triglyceride lowering therapy * have a fasting TG level of at least 880 mg/dL (10 mmol/L) * be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control * must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent * meet body weight requirements Exclusion Criteria: * Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke. * Patients with class 3 or 4 heart failure * Uncontrolled hypothyroidism or other uncontrolled endocrine disease * Known, clinically significant eye abnormalities, such as cataracts * History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1 * Alkaline phosphatase greater than 2 times ULN * Serum creatinine greater than 2.0 mg/dL * Liver cirrhosis and severe liver steatosis * Clinically significant infection, malignancy, or psychosis * Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored * Participation in any other investigational study within the last 30 days * Breastfeeding or pregnant * Current drug or alcohol abuse * Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study * Unwillingness to comply with study procedures or unwillingness to cooperate fully



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 9 locations
Suspended
Metabolic and Atherosclerosis Research CenterCincinnati, United StatesSee the location
Suspended
The Methodist HospitalHouston, United States
Suspended
Academic Medical Center AmsterdamAmsterdam, Netherlands
Suspended
Andromed NoordGroningen, Netherlands

Suspended9 Study Centers
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