HypercholesteremiaPhase 2ROYAL-1NCT02634151
A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
A Phase 2 study testing Gemcabene in people with Hypercholesteremia, run by NeuroBo Pharmaceuticals Inc. at 24 sites in United States.
Trial summary
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Read more about this study
- Who is it for?
- Ages 18 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?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 24 sitesUnited States
- Study dates
- Nov 2016to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) > 2x ULN (upper limit of normal), total bilirubin > 1.5x ULN, or alkaline phosphate > 2x ULN based on appropriate age and gender normal values. Subjects with bilirubin > 1.5x ULN and a 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, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;
- Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
- Moderate to severe renal insufficiency define as an estimated GFR < 60mL/min/1.73m (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or Screening Visit;
- Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria) confirmed by reflexive urine protein:creatinine ration testing;
Show all 19Show fewer
- Uncontrolled thyroid disease; hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or > 1.5x ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to Screening;
- Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c value > 8.5% based on results from the Pre-Screening or Screening Visit, or taking a thiazolidinedione (i.e. pioglitazone or rosiglitazone);
- 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. Subjects 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;
- Inadequate wash-out of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4 weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile acid sequestrants (4 weeks prior to the Screening Visit);
- Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;
- Use of any excluded medications or supplements (e.g. potent cytochrome P450 [CYP] 3A4 inhibitors as described in Appendix D;
- History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);
- Previously treated with gemcabene (CI-1027), participation in another clinical study of an investigational agent or device concurrently or within 1 month prior 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;
- Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Atlantic Clinical Research Collaborative- Cardiology
Atlantis, Florida, 33462
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211
Central Research Associates, Inc.
Birmingham, Alabama, 35205
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45219
Sentral Clinical Research Services
Cincinnati, Ohio, 45236
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45246
Evanston Premier Healthcare Research, LLC
Evanston, Illinois, 60201
Associates in Medicine
Houston, Texas, 77027
National Research Institute
Huntington Park, California, 90255
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Health Awareness, Inc.
Jupiter, Florida, 33458
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446
National Research Institute
Los Angeles, California, 90057
L-MARC
Louisville, Kentucky, 40213
Meridien Research, Inc.
Maitland, Florida, 32751
Mid-Hudson Medical Research
New Windsor, New York, 12553
Progressive Medical Research
Port Orange, Florida, 32127
National Research Institute
Richmond, Virginia
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Diagnostics Research Grup
San Antonio, Texas, 78229
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
Varkey Medical
Tampa, Florida, 33626
About this study
Official title: A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy
The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.
- Conditions
- Hypercholesteremia
- 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
Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.
PlaceboDrug
Three placebo tablets administered orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks. Receives: Drug: Placebo |
| Gemcabene 600 mg | Experimental | Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks. 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 Week 12
Measured: Baseline, Week 12
Secondary outcomes (40)
Percent Change From Baseline in LDL-C by Statin Intensity Stratum
The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity \& moderate intensity based on their statin doses.
Measured: Baseline, Week 12
Change From Baseline in LDL-C
Measured: Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12
Percent Change From Baseline in LDL-C
Measured: Baseline, average of weeks 8 and 12
Percent Change From Baseline in Non-HDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Non-HDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in TC
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in TC
Measured: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in TG
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in TG
Measured: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in VLDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in VLDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in HDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in HDL-C
Measured: Baseline, Weeks 2, 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥10%
Measured: Weeks 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥15%
Measured: Weeks 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥20%
Measured: Weeks 4, 8 and 12
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Measured: Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein B
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein B
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein A-I
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein A-I
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein A-II
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein A-II
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein C-II
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein C-II
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein C-III
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein C-III
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein E
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein E
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Lipoprotein(a)
Measured: Baseline, Weeks 4, 8 and 12
Change From Baseline in Lipoprotein(a)
Measured: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in High-sensitivity C-reactive Protein
Measured: Baseline, Week 12
Change From Baseline in High-sensitivity C-reactive Protein
Measured: Baseline, Week 12
Percent Change From Baseline in Fibrinogen
Measured: Baseline, Week 12
Change From Baseline in Fibrinogen
Measured: Baseline, Week 12
Percent Change From Baseline in Serum Amyloid A
Measured: Baseline, Week 12
Change From Baseline in Serum Amyloid A
Measured: Baseline, Week 12
Percent Change From Baseline in Adiponectin
Measured: Baseline, Week 12
Change From Baseline in Adiponectin
Measured: Baseline, Week 12
Change From Baseline in Framingham Risk Score
Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 [best] to greater than or equal to 14 [worst] for men; less than or equal to negative 2 [best] and greater than or equal to 17 [worst] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionAug 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 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
- NCT02634151
- Sponsor's protocol ID
- GEM-301
- Acronym
- ROYAL-1
- Status last verified
- Jun 2020
- First submitted
- 11 Dec 2015
- Last updated
- 25 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy
- ClinicalTrials.gov ID
- NCT02634151
- Acronym / sponsor ID
- ROYAL-1 / GEM-301
- Conditions
- Hypercholesteremia
- Keywords
- LDL-C, Lipid Regulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- NeuroBo Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Dec 2015 (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 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants on stable statin therapy received matching placebo orally, once daily for 12 weeks. |
| Gemcabene 600 mg | Experimental | Drug: GemcabeneParticipants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) > 2x ULN (upper limit of normal), total bilirubin > 1.5x ULN, or alkaline phosphate > 2x ULN based on appropriate age and gender normal values. Subjects with bilirubin > 1.5x ULN and a 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, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;
- Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;
- Moderate to severe renal insufficiency define as an estimated GFR < 60mL/min/1.73m (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or 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 |
|---|---|---|
| GemcabeneTwo 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks. | Drug | Gemcabene 600 mg |
| PlaceboThree placebo tablets administered orally once daily for 12 weeks. | Drug | Placebo |
Primary outcome
Percent Change From Baseline in LDL-C at Week 12
Time frame: Baseline, Week 12
40 secondary outcomes
Percent Change From Baseline in LDL-C by Statin Intensity Stratum
Time frame: Baseline, Week 12
Change From Baseline in LDL-C
Time frame: Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12
Percent Change From Baseline in LDL-C
Time frame: Baseline, average of weeks 8 and 12
Percent Change From Baseline in Non-HDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in Non-HDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in TC
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in TC
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in TG
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in TG
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in VLDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in VLDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Percent Change From Baseline in HDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Change From Baseline in HDL-C
Time frame: Baseline, Weeks 2, 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥10%
Time frame: Weeks 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥15%
Time frame: Weeks 4, 8 and 12
Number of Participants Achieving LDL-C Reduction of ≥20%
Time frame: Weeks 4, 8 and 12
Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)
Time frame: Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein B
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein B
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein A-I
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein A-I
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein A-II
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein A-II
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein C-II
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein C-II
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein C-III
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein C-III
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Apolipoprotein E
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Apolipoprotein E
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in Lipoprotein(a)
Time frame: Baseline, Weeks 4, 8 and 12
Change From Baseline in Lipoprotein(a)
Time frame: Baseline, Weeks 4, 8 and 12
Percent Change From Baseline in High-sensitivity C-reactive Protein
Time frame: Baseline, Week 12
Change From Baseline in High-sensitivity C-reactive Protein
Time frame: Baseline, Week 12
Percent Change From Baseline in Fibrinogen
Time frame: Baseline, Week 12
Change From Baseline in Fibrinogen
Time frame: Baseline, Week 12
Percent Change From Baseline in Serum Amyloid A
Time frame: Baseline, Week 12
Change From Baseline in Serum Amyloid A
Time frame: Baseline, Week 12
Percent Change From Baseline in Adiponectin
Time frame: Baseline, Week 12
Change From Baseline in Adiponectin
Time frame: Baseline, Week 12
Change From Baseline in Framingham Risk Score
Time frame: Baseline, Week 12
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.
Related trials for Hypercholesteremia
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe
Hypercholesterolemia, Dyslipidemias
RecruitingPhase 3
Study of Zodasiran in Adolescent Participants With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia
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.
24 sites in 1 country: 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 24 sites 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 0 inclusion and 19 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 24 sites 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?
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 Week 12 (time frame: Baseline, Week 12). 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 25 Jun 2020.