HypercholesterolemiaPhase 2NCT02591836
Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin
A Phase 2 study testing Gemcabene and Atorvastatin in people with Hypercholesterolemia, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The primary purpose of this placebo-controlled study is to evaluate the low-density lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Gemcabene and Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 277 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2003
- 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
- Males and Females
- 18-70 years old
- Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR
- Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:
- ≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
- ≥ 160 mg/dL if NCEP ATP III CHD risk < 10%
- Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL-C variability; and
- Had a mean LDL-C < 250 mg/dL at 2 qualifying visits
Who cannot join
- Women of childbearing potential, pregnant or lactating;
- Body Mass Index (BMI) >38kg/m²;
- TG >400 mg/dL at Visit B2 or B3
- Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
- Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
- Uncontrolled hypertension*
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- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones
- Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;
- Hepatic dysfunction
- Uncontrolled hypothyroidism
- Abnormal urinalysis
- Currently taking any of the following medications:
- Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;
- Thiazolidinediones (Avandia, Actos);
- Immunosuppressive agents;
- St. John's wort
- Taking any of the following lipid-altering medications within 5 weeks prior to randomization:
- Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;
- Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);
- Neomycin (oral);
- Adrenocortical steroids*
- Sibutramine (Meridia);
- Insulin;
- Orlistat (Xenical);
- Isotretinoin
About this study
Official title: An 8-Week, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients
The primary purpose of this placebo-controlled study is to evaluate the low-density lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.
Secondary purposes include evaluating the effects of high-sensitivity C-reactive protein (hsCRP), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.
- Conditions
- Hypercholesterolemia
- Being tested
- Gemcabene, Atorvastatin, 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
Gemcabene
AtorvastatinDrug
Atorvastatin
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 300 mg | Experimental | Gemcabene 300 mg QD Receives: Drug: Gemcabene |
| Gemcabene 600 mg | Experimental | Gemcabene 600 mg QD Receives: Drug: Gemcabene |
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg QD Receives: Drug: Gemcabene |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Atorvastatin 10 mg | Active comparator | Not described Receives: Drug: Atorvastatin |
| Atorvastatin 40 mg | Active comparator | Not described Receives: Drug: Atorvastatin |
| Atorvastatin 80 mg | Active comparator | Not described Receives: Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 10 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 40 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 80 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 10 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 40 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 80 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 10 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 40 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 80 mg | Experimental | Not described Receives: Drug: Gemcabene; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C percent change from baseline
Measured: 56 days
Secondary outcomes (5)
HDL-C percent change from baseline
Measured: 56 days
TG percent change from baseline
Measured: 56 days
Apolipoprotein-B percent change from baseline
Measured: 56 days
Adverse Events
Measured: 56 days
Clinical Laboratory
Clinical Laboratory Abnormalities
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 posted30 Oct 2015 (estimated)
- Study startJan 2003
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 277 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
- NCT02591836
- Sponsor's protocol ID
- A4141001
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2015
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
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, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT02591836
- Acronym / sponsor ID
- A4141001
- Conditions
- Hypercholesterolemia
- Keywords
- LDL-C, Lipid Regulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 30 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 primary purpose of this placebo-controlled study is to evaluate the low-density lipoprotein cholesterol (LDL-C) efficacy and dose-response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.
Secondary purposes include evaluating the effects of high-sensitivity C-reactive protein (hsCRP), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 300 mg | Experimental | Drug: GemcabeneGemcabene 300 mg QD |
| Gemcabene 600 mg | Experimental | Drug: GemcabeneGemcabene 600 mg QD |
| Gemcabene 900 mg | Experimental | Drug: GemcabeneGemcabene 900 mg QD |
| Placebo | Placebo comparator | Drug: Placebo |
| Atorvastatin 10 mg | Active comparator | Drug: Atorvastatin |
| Atorvastatin 40 mg | Active comparator | Drug: Atorvastatin |
| Atorvastatin 80 mg | Active comparator | Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 10 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 40 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 300 mg & Atorvastatin 80 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 10 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 40 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 600 mg & Atorvastatin 80 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 10 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 40 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
| Gemcabene 900 mg & Atorvastatin 80 mg | Experimental | Drug: Gemcabene, Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and Females
- 18-70 years old
- Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR
- Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:
- ≥ 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk ≥ 10%; OR
Key exclusion criteria (25 listed)
- Women of childbearing potential, pregnant or lactating;
- Body Mass Index (BMI) >38kg/m²;
- TG >400 mg/dL at Visit B2 or B3
- Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);
- Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization
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 |
|---|---|---|
| GemcabeneGemcabene | Drug | Gemcabene 300 mg, Gemcabene 300 mg & Atorvastatin 10 mg, Gemcabene 300 mg & Atorvastatin 40 mg, Gemcabene 300 mg & Atorvastatin 80 mg, Gemcabene 600 mg, Gemcabene 600 mg & Atorvastatin 10 mg, Gemcabene 600 mg & Atorvastatin 40 mg, Gemcabene 600 mg & Atorvastatin 80 mg, Gemcabene 900 mg, Gemcabene 900 mg & Atorvastatin 10 mg, Gemcabene 900 mg & Atorvastatin 40 mg, Gemcabene 900 mg & Atorvastatin 80 mg |
| AtorvastatinAtorvastatin | Drug | Atorvastatin 10 mg, Atorvastatin 40 mg, Atorvastatin 80 mg, Gemcabene 300 mg & Atorvastatin 10 mg, Gemcabene 300 mg & Atorvastatin 40 mg, Gemcabene 300 mg & Atorvastatin 80 mg, Gemcabene 600 mg & Atorvastatin 10 mg, Gemcabene 600 mg & Atorvastatin 40 mg, Gemcabene 600 mg & Atorvastatin 80 mg, Gemcabene 900 mg & Atorvastatin 10 mg, Gemcabene 900 mg & Atorvastatin 40 mg, Gemcabene 900 mg & Atorvastatin 80 mg |
| Placebo | Drug | Placebo |
Primary outcome
LDL-C percent change from baseline
Time frame: 56 days
5 secondary outcomes
HDL-C percent change from baseline
Time frame: 56 days
TG percent change from baseline
Time frame: 56 days
Apolipoprotein-B percent change from baseline
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.
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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 and Atorvastatin 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 8 inclusion and 25 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 (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.