Study to Assess the Effects of Mipomersen on Lipid and Lipoprotein Metabolism in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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The primary objective of this Phase I exploratory study is to determine the effects of mipomersen on the hepatic production of apolipoprotein-B (apo B) in very low density lipoprotein (VLDL) compared to baseline levels. The study will consist of a Screening Period, a 1-week Run-in Period to establish a stable diet, an approximate 11-week Treatment Period with Placebo or Mipomersen, and a 25-week Post-Treatment Follow-up Period. The total duration of any given subject's participation will be approximately 40 weeks.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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mipomersen

mipomersen 200mg subcutaneously (SC) once weekly

Group Type EXPERIMENTAL

mipomersen

Intervention Type DRUG

mipomersen 200mg subcutaneously (SC) once weekly

Placebo

Placebo administered subcutaneously (SC) once weekly

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered subcutaneously (SC) once weekly

Interventions

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mipomersen

mipomersen 200mg subcutaneously (SC) once weekly

Intervention Type DRUG

Placebo

Placebo administered subcutaneously (SC) once weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-pregnant, non-lactating, surgically sterile, postmenopausal, abstinent, or the subject or partner is compliant with an acceptable contraceptive regimen for 4 weeks prior to Screening and willing to remain compliant with the contraceptive regimen throughout treatment and for 25 weeks after the last investigational product dose
* Body weight \>50 kg, body mass index (BMI) ≤38 kg/m2, and stable weight (i.e., within 5% of mean body weight) for \> 8 weeks prior to Screening
* Fasting TG levels of ≤170 mg/dL, fasting serum blood glucose of ≤115 mg/dL, and an HbA1c ≤6.5%

Exclusion Criteria

* Presence of any clinically significant abnormal laboratory profiles, physical exams, vital signs, or ECGs
* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, infectious, or psychiatric disease
* Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \>1 year) at Screening
* History of relevant food and/or drug allergies (i.e., allergy to heparin or any significant food allergy that could preclude a stable diet)
* The subject is receiving prescription lipid-lowering therapies such as statins, bile acid sequestrants, niacin/nicotinic acid, and/or fibrates or over-the-counter (OTC) fish oils, flaxseed, red rice or nutrient supplements that might affect lipid levels
* The subject is unwilling to limit alcohol consumption for the entire duration of the study
* The subject smokes \>5 cigarettes per day

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes