HypercholesteremiaPhase 2NCT02722408
Efficacy and Safety of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid-Lowering Therapy (COBALT-1)
A Phase 2 study testing Gemcabene in people with Hypercholesteremia, run by NeuroBo Pharmaceuticals Inc. at 7 sites in 3 countries.
Trial summary
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Hypercholesteremia
- What is being tested?
- Gemcabene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2016to Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of written and signed informed consent (by patient or legal guardian) prior to any study-specific procedure;
- Male or female ≥17 years of age at time of consent;
- Diagnosis of HoFH by genetic confirmation (including compound heterozygosity) or a clinical diagnosis based on either (1) a history of an untreated LDL-C concentration >500 mg/dL (12.92 mmol/L) together with either appearance of xanthoma before 10 years of age, or evidence of heterozygous familial hypercholesterolemia in both parents or, if history is unavailable, (2) LDL-C >300 mg/dL (7.76 mmol/L) on maximally tolerated lipid-lowering drug therapy;
- Currently on a stable, low-fat, low-cholesterol diet in combination with a pre-existing, regulatory-approved, not excluded lipid-lowering therapy (i.e., statins, monoclonal antibodies to PCSK9, cholesterol absorption inhibitors, bile acid sequestrants, or nicotinic acid, or any combination thereof) at a stable dose for at least 4 weeks prior to the Screening Visit;
- Fasting LDL-C value >130 mg/dL (3.36 mmol/L) at the Screening Visit;
- Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;
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- Weight ≥50 kg;
- Female patients must not be pregnant or lactating. Women of child-bearing potential must have a negative serum pregnancy test at the Screening Visit and negative urine dipstick on Day 1 prior to dosing in order to qualify for the study. Women who are surgically sterile or are clinically confirmed to be post-menopausal (i.e., documented amenorrhea for ≥1 year in the absence of other biological or physiological causes) are not considered to be of child-bearing potential; and
- Women of child-bearing potential must agree to use acceptable methods of contraception throughout the duration of the study and for 30 days after the last dose of study drug. For this study, double-barrier contraception is required.
Who cannot join
- Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome or hypothyroidism);
- Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2 × the upper limit of normal [ULN]; total bilirubin >1.5 × ULN; or alkaline phosphatase >2 × ULN based on appropriate age and gender normal values). Patients with bilirubin >1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
- Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child Pugh classification;
- Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B virus [HBV], hepatitis C virus [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, or known diagnosis of human immunodeficiency virus (HIV);
- Triglycerides value >400 mg/dL (4.52 mmol/L) at the Screening Visit;
- Moderate to severe renal insufficiency defined as an estimated GFR <30 mL/min/1.73m2 (calculated using The Chronic Kidney Disease Epidemiology Collaboration equation) at the Screening Visit;
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- Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria), confirmed by reflexive urine protein:creatinine ratio testing;
- Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or >1.5 × ULN, respectively, at the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to the Screening Visit;
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] value >8%), or any diabetic patient taking insulin and/or thiazolidinediones;
- New York Heart Association Class III or IV heart failure;
- Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit. Patients with adequately treated stable angina, per Investigator assessment, may be included;
- Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior to dosing ECG (QTcF >450 msec for men and >470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;
- Uncontrolled hypertension, defined as sitting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg, and confirmed by repeat measurement;
- Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;
- Use of fibrate lipid-lowering agent 6 weeks prior to the Screening Visit;
- Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid lowering agent;
- Use of apheresis (LDL or plasma) 8 weeks prior to the Screening Visit;
- Use of lomitapide 2 months prior to the Screening Visit;
- Use of mipomersen 5 months prior to the Screening Visit;
- Use of any excluded medications or supplements (e.g., potent cytochrome P450 [CYP] 3A4 inhibitors);
- History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subject restrictions;
- Previously treated with gemcabene;
- Participation in another clinical study of an investigational agent or device concurrently or within 1 month prior to the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit; or
- Any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Canada3 sites
Ecogene-21
Chicoutimi, Quebec
Robarts Research Institute
London, Ontario
Montreal Heart Institute
Montreal, Quebec
Israel3 sites
Wolfson Medical Center Internal Medicine Dept.
Holon
Center for Research, Prevention and Treatment of Atherosclerosis - Cardiology Department of Medicine Kiryat Hadassah
Jerusalem
Ziv Medical Center Internal Medicine Department
Safed
United States1 site
Westside Medical Associates of Los Angeles
Beverly Hills, California
About this study
Official title: A Phase 2 Open-Label, Dose-Finding Study to Assess the Efficacy, Safety, and Tolerability of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid Lowering Therapy (COBALT-1)
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.
- Conditions
- Hypercholesteremia
- Being tested
- Gemcabene
- 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
300 mg tablet orally once daily for four weeks followed by 600 mg tablet orally once daily for four weeks followed by 900 mg tablet orally once daily for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gemcabene | Experimental | Participants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 milligram (mg) of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. Participants were followed until Day 112. Receives: Drug: Gemcabene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C at Day 28
Measured: Baseline, day 28
Percent Change From Baseline in LDL-C at Day 56
Measured: Baseline, day 56
Percent Change From Baseline in LDL-C at Day 84
Measured: Baseline, day 84
Secondary outcomes (46)
Change From Baseline in Fasting LDL-C
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Non-HDL-C
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Non-HDL-C
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Total Cholesterol (TC)
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Total Cholesterol (TC)
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Triglycerides (TG)
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Triglycerides (TG)
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting HDL-C
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting HDL-C
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting VLDL-C
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting VLDL-C
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting TC as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting TC as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting TG as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting TG as Per Receptor Mutation Status
Receptor mutation status was categorized as LDLr status and EAS clinical diagnosis of HoFH which was reported in this outcome measure.
Measured: Baseline, days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥15%
Measured: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥20%
Measured: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥25%
Measured: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥30%
Measured: Days 28, 56 and 84
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Measured: Days 28, 56 and 84
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Measured: Baseline, days 28, 56 and 84
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fibrinogen
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fibrinogen
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Lipoprotein(a)
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Lipoprotein(a)
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein B
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein B
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein A-I
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein A-I
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein A-II
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein A-II
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein C-II
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein C-II
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein C-III
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein C-III
Measured: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein E
Measured: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein E
Measured: Baseline, days 28, 56 and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesteremiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02722408
- Sponsor's protocol ID
- GEM-201
- Status last verified
- Jun 2020
- First submitted
- 12 Mar 2016
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gaudet D, Durst R, Lepor N, Bakker-Arkema R, Bisgaier C, Masson L, Golden L, Kastelein JJ, Hegele RA, Stein E. Usefulness of Gemcabene in Homozygous Familial Hypercholesterolemia (from COBALT-1). Am J Cardiol. 2019 Dec 15;124(12):1876-1880. doi: 10.1016/j.amjcard.2019.09.010. Epub 2019 Sep 26.
PubMed 31685212
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-Label, Dose-Finding Study to Assess the Efficacy, Safety, and Tolerability of Gemcabene in Patients With Homozygous Familial Hypercholesterolemia on Stable, Lipid Lowering Therapy (COBALT-1)
- ClinicalTrials.gov ID
- NCT02722408
- Acronym / sponsor ID
- GEM-201
- Conditions
- Hypercholesteremia
- Keywords
- LDL-C, Lipid Regulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 25 Jun 2020
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 was to assess the efficacy, safety, and tolerability of multiple doses of Gemcabene in patients with HoFH on stable, lipid-lowering therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcabene | Experimental | Drug: GemcabeneParticipants with homozygous familial hypercholesterolemia (HoFH) on stable lipid lowering therapy received 300 milligram (mg) of Gemcabene, orally once daily from day 1 to 28 followed by 600 mg of Gemcabene, orally once daily from day 29 to 56 followed by 900 mg of Gemcabene, orally once daily from day 57 to 84. Participants were followed until Day 112. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of written and signed informed consent (by patient or legal guardian) prior to any study-specific procedure;
- Male or female ≥17 years of age at time of consent;
- Diagnosis of HoFH by genetic confirmation (including compound heterozygosity) or a clinical diagnosis based on either (1) a history of an untreated LDL-C concentration >500 mg/dL (12.92 mmol/L) together with either appearance of xanthoma before 10 years of age, or evidence of heterozygous familial hypercholesterolemia in both parents or, if history is unavailable, (2) LDL-C >300 mg/dL (7.76 mmol/L) on maximally tolerated lipid-lowering drug therapy;
- Currently on a stable, low-fat, low-cholesterol diet in combination with a pre-existing, regulatory-approved, not excluded lipid-lowering therapy (i.e., statins, monoclonal antibodies to PCSK9, cholesterol absorption inhibitors, bile acid sequestrants, or nicotinic acid, or any combination thereof) at a stable dose for at least 4 weeks prior to the Screening Visit;
- Fasting LDL-C value >130 mg/dL (3.36 mmol/L) at the Screening Visit;
Key exclusion criteria (24 listed)
- Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome or hypothyroidism);
- Abnormal liver function test at the Screening Visit (aspartate aminotransferase or alanine aminotransferase >2 × the upper limit of normal [ULN]; total bilirubin >1.5 × ULN; or alkaline phosphatase >2 × ULN based on appropriate age and gender normal values). Patients with bilirubin >1.5 × ULN and history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;
- Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child Pugh classification;
- Active liver disease (e.g., cirrhosis, alcoholic liver disease, hepatitis B virus [HBV], hepatitis C virus [HCV], autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, or known diagnosis of human immunodeficiency virus (HIV);
- Triglycerides value >400 mg/dL (4.52 mmol/L) at the Screening Visit;
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 |
|---|---|---|
| Gemcabene300 mg tablet orally once daily for four weeks followed by 600 mg tablet orally once daily for four weeks followed by 900 mg tablet orally once daily for four weeks. | Drug | Gemcabene |
Primary outcome
Percent Change From Baseline in LDL-C at Day 28
Time frame: Baseline, day 28
Percent Change From Baseline in LDL-C at Day 56
Time frame: Baseline, day 56
Percent Change From Baseline in LDL-C at Day 84
Time frame: Baseline, day 84
46 secondary outcomes
Change From Baseline in Fasting LDL-C
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Non-HDL-C
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Non-HDL-C
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Total Cholesterol (TC)
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Total Cholesterol (TC)
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Triglycerides (TG)
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Triglycerides (TG)
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting HDL-C
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting HDL-C
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting VLDL-C
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting VLDL-C
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting LDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Non-HDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting VLDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting HDL-C as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting TC as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting TC as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting TG as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting TG as Per Receptor Mutation Status
Time frame: Baseline, days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥15%
Time frame: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥20%
Time frame: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥25%
Time frame: Days 28, 56 and 84
Number of Participants Achieving LDL-C Reduction of ≥30%
Time frame: Days 28, 56 and 84
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Time frame: Days 28, 56 and 84
Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fibrinogen
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fibrinogen
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Lipoprotein(a)
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Lipoprotein(a)
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein B
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein B
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein A-I
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein A-I
Time frame: Baseline, days 28, 56 and 84
Percent Change From Baseline in Fasting Apolipoprotein A-II
Time frame: Baseline, days 28, 56 and 84
Change From Baseline in Fasting Apolipoprotein A-II
Time frame: Baseline, days 28, 56 and 84
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31685212Gaudet D, Durst R, Lepor N, Bakker-Arkema R, Bisgaier C, Masson L, Golden L, Kastelein JJ, Hegele RA, Stein E. Usefulness of Gemcabene in Homozygous Familial Hypercholesterolemia (from COBALT-1). Am J Cardiol. 2019 Dec 15;124(12):1876-1880. doi: 10.1016/j.amjcard.2019.09.010. Epub 2019 Sep 26.
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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.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcabene in people with Hypercholesteremia, run by NeuroBo Pharmaceuticals Inc. at 7 sites in 3 countries.
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 9 inclusion and 24 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 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, Israel, 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. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in LDL-C at Day 28 (time frame: Baseline, day 28). The study lists 3 primary outcomes in all. 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 NCT02722408, 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 25 Jun 2020.