HyperlipidemiaPhase 2NCT01607294
A Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
A Phase 2 study testing ETC-1002 in people with Hyperlipidemia and Type 2 Diabetes, run by Esperion Therapeutics, Inc. at 1 site in United States.
Trial summary
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipidemia, Type 2 Diabetes
- What is being tested?
- ETC-1002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
- Conditions
- Hyperlipidemia, Type 2 Diabetes
- Being tested
- ETC-1002, Placebo
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETC-1002Drug
ETC-1002 Daily for 4 weeks
PlaceboDrug
Placebo Daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| ETC-1002 | Experimental | ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day Receives: Drug: ETC-1002 |
| Placebo | Placebo comparator | Placebo daily 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
evaluate the change in LDL-C from baseline to various time points
Measured: 4 weeks
Secondary outcomes (3)
assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin
evaluate the change in glucose and insulin from baseline to various time points
Measured: 4 weeks
assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes
evaluate the change in HOMA-IR from baseline to various time points
Measured: 4 weeks
assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters
evaluate any changes in safety parameters during the course of the study.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607294
- Sponsor's protocol ID
- 1002-005
- Status last verified
- Mar 2019
- First submitted
- 26 Apr 2012
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.
PubMed 24385236
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Single Center Study to Evaluate the Efficacy and Safety of ETC 1002 in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01607294
- Acronym / sponsor ID
- 1002-005
- Conditions
- Hyperlipidemia, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 2 study will asses the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETC-1002 | Experimental | Drug: ETC-1002ETC-1002 daily Weeks 1-2, 80 mg/day; Weeks 3-4, 120 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETC-1002ETC-1002 Daily for 4 weeks | Drug | ETC-1002 |
| PlaceboPlacebo Daily for 4 weeks | Drug | Placebo |
Primary outcome
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes
Time frame: 4 weeks
evaluate the change in LDL-C from baseline to various time points
3 secondary outcomes
assess the effect of ETC-1002 versus placebo on glycemic parameters including fasting plasma and postprandial glucose and insulin
Time frame: 4 weeks
assess the effect of ETC-1002 versus placebo on measures of insulin sensitivity in subjects with type 2 diabetes
Time frame: 4 weeks
assess safety using adverse event reports, physical exams, vital signs, ECGs and clinical laboratory parameters
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Derived from this study: PubMed 24385236Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ETC-1002 in people with Hyperlipidemia and Type 2 Diabetes, run by Esperion Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the LDL-C lowering efficacy of ETC-1002 versus placebo in subjects with type 2 diabetes (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01607294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.