Hyperlipidemia, Type 2 Diabetes
Conditions
Brief summary
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
Interventions
DRUGETC-1002
ETC-1002 Daily for 4 weeks
DRUGPlacebo
Placebo Daily for 4 weeks
Sponsors
Esperion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes meeting all of the following: * Minimum 6 month history of diabetes prior to screening visit; * Fasting C-peptide ≥ 0.8 ng/mL at screening visit; * HbA1C at screening visit 7-10%; * Fasting glucose from 140-270 mg/dL on Day -7 following washout of all glucose regulating drugs and supplements. * BMI at screening visit from 25-35 kg/m2; * LDL-C at screening ≥ 100 mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes | 4 weeks | evaluate the change in LDL-C from baseline to various time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin | 4 weeks | evaluate the change in glucose and insulin from baseline to various time points |
| assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes | 4 weeks | evaluate the change in HOMA-IR from baseline to various time points |
| assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters | 4 weeks | evaluate any changes in safety parameters during the course of the study. |
Countries
United States
Outcome results
None listed