HypercholesterolemiaPhase 2NCT02585869
Efficacy and Safety of Gemcabene in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
A Phase 2 study testing Gemcabene 150 mg, Gemcabene 300 mg and Gemcabene 600 mg in people with Hypercholesterolemia and Hypertriglyceridemia, run by NeuroBo Pharmaceuticals Inc..
Trial summary
The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Hypertriglyceridemia
- What is being tested?
- Gemcabene 150 mg, Gemcabene 300 mg and Gemcabene 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Dec 1999to Jun 2001
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or naturally postmenopausal or surgically menopausal women
- 18 to 80 years of age
- Baseline HDL-C <35 mg/dL (0.9 mmol/L)
Who cannot join
- Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- Body Mass Index (BMI) >35 kg/m2
- Uncontrolled Hypertension >95 mm Hg
- 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)
- Uncontrolled hypothyroidism (TSH >1.5 × 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 3 months
About this study
Official title: A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
The purpose of this study is to evaluate the effect of gemcabene on HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia
- Being tested
- Gemcabene 150 mg, Gemcabene 300 mg, Gemcabene 600 mg, Gemcabene 900 mg, Placebo
- Keywords
- Lipid Regulator, TG
- Medical subject headings
- Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcabene 150 mgDrug
Blinded capsules and tablets, 150 mg, once daily, 84 days
Gemcabene 300 mgDrug
Blinded capsules and tablets, 300 mg, once daily, 84 days
Gemcabene 600 mgDrug
Blinded capsules and tablets, 600 mg, once daily, 84 days
Gemcabene 900 mgDrug
Blinded capsules and tablets, 900 mg, once daily, 84 days
PlaceboDrug
Blinded capsule and tablets, once daily, 84 days
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene 150 mg | Experimental | Gemcabene 150 mg once daily (QD) Receives: Drug: Gemcabene 150 mg |
| Gemcabene 300 mg | Experimental | Gemcabene 300 mg once daily (QD) Receives: Drug: Gemcabene 300 mg |
| Gemcabene 600 mg | Experimental | Gemcabene 600 mg once daily (QD) Receives: Drug: Gemcabene 600 mg |
| Gemcabene 900 mg | Experimental | Gemcabene 900 mg once daily (QD) Receives: Drug: Gemcabene 900 mg |
| Placebo | Placebo comparator | Placebo once daily (QD) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-C - percent change from baseline
Measured: 84 days
Secondary outcomes (3)
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
Measured: 84 days
Adverse Events
Measured: 84 days
Clinical Laboratory - hematology, chemistry, urinalysis
Clinical Laboratory Abnormalities
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startDec 1999
- Primary completionJun 2001
- Study completionJun 2001
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
- 161 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
- NCT02585869
- Sponsor's protocol ID
- 1027-004
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2015
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.
PubMed 12943873
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
- A 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI-1027 in Patients With Low HDL-C and Either Normal or Elevated Triglycerides
- ClinicalTrials.gov ID
- NCT02585869
- Acronym / sponsor ID
- 1027-004
- Conditions
- Hypercholesterolemia, Hypertriglyceridemia
- Keywords
- Lipid Regulator, TG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 1999
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 23 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 HDL-C, LDL-C, TG, and other lipid levels in patients with low HDL-C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gemcabene 150 mg | Experimental | Drug: Gemcabene 150 mgGemcabene 150 mg once daily (QD) |
| Gemcabene 300 mg | Experimental | Drug: Gemcabene 300 mgGemcabene 300 mg once daily (QD) |
| Gemcabene 600 mg | Experimental | Drug: Gemcabene 600 mgGemcabene 600 mg once daily (QD) |
| Gemcabene 900 mg | Experimental | Drug: Gemcabene 900 mgGemcabene 900 mg once daily (QD) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily (QD) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or naturally postmenopausal or surgically menopausal women
- 18 to 80 years of age
- Baseline HDL-C <35 mg/dL (0.9 mmol/L)
Key exclusion criteria (8 listed)
- Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
- Body Mass Index (BMI) >35 kg/m2
- Uncontrolled Hypertension >95 mm Hg
- Uncontrolled diabetes mellitus (HbA1c >10%)
- Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN);
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 |
|---|---|---|
| Gemcabene 150 mgBlinded capsules and tablets, 150 mg, once daily, 84 days | Drug | Gemcabene 150 mg |
| Gemcabene 300 mgBlinded capsules and tablets, 300 mg, once daily, 84 days | Drug | Gemcabene 300 mg |
| Gemcabene 600 mgBlinded capsules and tablets, 600 mg, once daily, 84 days | Drug | Gemcabene 600 mg |
| Gemcabene 900 mgBlinded capsules and tablets, 900 mg, once daily, 84 days | Drug | Gemcabene 900 mg |
| PlaceboBlinded capsule and tablets, once daily, 84 days | Drug | Placebo |
Primary outcome
HDL-C - percent change from baseline
Time frame: 84 days
3 secondary outcomes
Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline
Time frame: 84 days
Adverse Events
Time frame: 84 days
Clinical Laboratory - hematology, chemistry, urinalysis
Time frame: 84 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.
- Background: PubMed 12943873Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. doi: 10.1016/s0002-9149(03)00721-5.
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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 150 mg, Gemcabene 300 mg and Gemcabene 600 mg in people with Hypercholesterolemia and Hypertriglyceridemia, 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?
HDL-C - percent change from baseline (time frame: 84 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 NCT02585869, 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.