CompletedNCT01105598Updated Mar 28, 2019

A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia

A Phase 1 interventional study of ETC-1002 or placebo and ETC-1002 or placebo in Mild Dyslipidemia, sponsored by Esperion Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Esperion Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Oct 2010, 16 years ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.

Conditions studied

Mild Dyslipidemia

In context

Lead sponsor

Esperion Therapeutics, Inc. is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy male and female subjects of non-child bearing potential as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements
Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight >50 kg

Exclusion criteria

Exclusion Criteria:

Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
Alanine aminotransferase (ALT) or aspartate amino transferase (AST) >1.2 x ULN; serum creatinine >ULN; hemoglobin \<12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
Use of tobacco or tobacco products
Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin >500 mg/day or fish oil which will not have been used for 3 months prior to randomization
Other exclusion criteria apply

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 53 participants (actual)

Study arms

Experimental
Cohort 1
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Drug: ETC-1002 or placebo
Experimental
Cohort 2
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Drug: ETC-1002 or placebo
Experimental
Cohort 3
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Drug: ETC-1002 or placebo
Experimental
Cohort 4
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Drug: ETC-1002 or placebo
Experimental
Cohort 5
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Drug: ETC-1002 or placebo

Interventions

DrugETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
DrugETC-1002 or placebo
ETC-1002 (optimized dose), daily for 28 days
DrugETC-1002 or placebo
ETC-1002 (20 mg), daily for 14 days

What researchers measure

Primary outcomes

Assessment of safety and tolerability using adverse event reports, physical exams, vitals signs, ECGs, and clinical lab values
Time frame: 14 or 28 days

Secondary outcomes

Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Pharmacodynamic endpoints include total cholesterol, low density lipoprotein-cholesterol (LDL-C), triglycerides (TG), high density lipoprotein-cholesterol (HDL-C) and free fatty acids (FFA)
Time frame: 14 or 28 days

Study locations

1 site

Jasper Clinic, Inc.
Kalamazoo, Michigan 49007, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01105598
Lead sponsor: Esperion Therapeutics, Inc.
Responsible party: Sponsor
First posted: Apr 16, 2010
Start date: Apr 20, 2010
Primary completion: Oct 2, 2010
Completion: Oct 2, 2010
Last update: Mar 28, 2019

Study contacts

Jim C Khalifa, MD

study director · Esperion Therapeutics, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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