HypercholesterolemiaPhase 2NCT02571257
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
A Phase 2 study testing Gemcabene in people with Hypercholesterolemia, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Gemcabene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Apr 2002
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females
- 18 to 65 years of age
- Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
Who cannot join
- If female, postmenopausal or surgically menopausal
- Triglycerides (TG) >400 mg/dL
- Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- Body Mass Index (BMI) >35 kg/m2
- Uncontrolled diabetes mellitus (HbA1c >10%)
- Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN)
- Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
- Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month
About this study
Official title: An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.
- Conditions
- Hypercholesterolemia
- Being tested
- Gemcabene, Placebo
- Keywords
- LDL-C, Lipid Regulator
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcabeneDrug
1-300 mg tablet, QD, 56 days
GemcabeneDrug
3-300 mg tablets, QD, 56 days
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment on stable background statin therapy Receives: Drug: Placebo |
| Gemcabene 300 mg QD | Experimental | Gemcabene (also known as CI-1027) treatment on stable background statin therapy Receives: Drug: Gemcabene |
| Gemcabene 900 mg QD | Experimental | Gemcabene (also known as CI-1027) treatment on stable background statin therapy Receives: Drug: Gemcabene |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C - percent change from baseline at Week 8
Measured: 56 days
Secondary outcomes (3)
Plasma lipid levels - percent change from baseline at Week 8
apolipoprotein B (apoB), total cholesterol (TC), C reactive protein (CRP), triglyceride (TG), very low density lipoprotein (VLDL-C), high density lipoprotein (HDL-C)
Measured: 56 days
Adverse Events
Measured: 56 days
Clinical Laboratory
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startAug 2000
- Primary completionApr 2002
- Study completionApr 2002
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 HypercholesterolemiaStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571257
- Sponsor's protocol ID
- 1027-018
- Status last verified
- Apr 2020
- First submitted
- 5 Oct 2015
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.
PubMed 27678439
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study in Hypercholesterolemic Patients to Determine the Efficacy and Safety of Combination Therapy With CI-1027 and a Statin
- ClinicalTrials.gov ID
- NCT02571257
- Acronym / sponsor ID
- 1027-018
- Conditions
- Hypercholesterolemia
- Keywords
- LDL-C, Lipid Regulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 8 Oct 2015 (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.
The purpose of this study is to evaluate the effect of gemcabene on LDL-C and other lipid parameters in hypercholesterolemic patients on a stable dose of a statin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment on stable background statin therapy |
| Gemcabene 300 mg QD | Experimental | Drug: GemcabeneGemcabene (also known as CI-1027) treatment on stable background statin therapy |
| Gemcabene 900 mg QD | Experimental | Drug: GemcabeneGemcabene (also known as CI-1027) treatment on stable background statin therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females
- 18 to 65 years of age
- Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
Key exclusion criteria (8 listed)
- If female, postmenopausal or surgically menopausal
- Triglycerides (TG) >400 mg/dL
- Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- Body Mass Index (BMI) >35 kg/m2
- Uncontrolled diabetes mellitus (HbA1c >10%)
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 |
|---|---|---|
| Gemcabene1-300 mg tablet, QD, 56 days | Drug | Gemcabene 300 mg QD |
| Gemcabene3-300 mg tablets, QD, 56 days | Drug | Gemcabene 900 mg QD |
| Placebo | Drug | Placebo |
Primary outcome
LDL-C - percent change from baseline at Week 8
Time frame: 56 days
3 secondary outcomes
Plasma lipid levels - percent change from baseline at Week 8
Time frame: 56 days
Adverse Events
Time frame: 56 days
Clinical Laboratory
Time frame: 56 days
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 9 Apr 2020.
- Derived from this study: PubMed 27678439Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcabene in people with Hypercholesterolemia, run by NeuroBo Pharmaceuticals Inc..
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 3 inclusion and 8 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
LDL-C - percent change from baseline at Week 8 (time frame: 56 days). 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 NCT02571257, 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 9 Apr 2020.