AtherosclerosisPhase 2NCT01258907
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
A Phase 2 study testing MLDL1278A and statin, stable dose in people with Atherosclerosis, run by Genentech, Inc. at 24 sites in 2 countries.
Trial summary
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- MLDL1278A and statin, stable dose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Mar 2010to Jul 2012
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of qualifying vessel (carotid or aortic) plaque inflammation
- Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
- Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
- For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study
Who cannot join
- Occurrence of a cardiovascular event < 6 months prior to screening
- Pregnant, planning to become pregnant during the study, or breastfeeding
- Clinically significant abnormal laboratory values or abnormal ECG or vital signs
- History of anaphylactic reactions
- Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started < 3 months prior to study entry
- Use of insulin, corticosteroids (oral, rectal, or injectable), or other immunosuppressive medications
Show all 12Show fewer
- Current or recent (within 4 weeks prior to screening) infection, including signs, symptoms or serology of any infection, including HIV, hepatitis B or C
- Impaired renal function
- History of malignancy within 2 years prior to screening
- Current life-threatening condition other than vascular disease that may prevent a patient from completing the study
- Use of an investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- Exposure to substantial radiation within 12 months prior to screening
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States22 sites
Study site
Boston, Massachusetts, 02114
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45227
Study site
Colorado Springs, Colorado, 80904
Study site
Gainesville, Florida, 32605
Study site
Haverhill, Massachusetts, 01830
Study site
Houston, Texas, 77002
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46260
Study site
Jacksonville, Florida, 32216
Study site
Kansas City, Missouri, 64111
Study site
Minneapolis, Minnesota, 55455
Study site
New York, New York, 10001
Study site
New York, New York, 10029
Study site
Newington, New Hampshire, 03801
Study site
North Massapequa, New York, 11758
Study site
Portland, Oregon, 97225-3411
Study site
Portland, Oregon, 97239
Study site
Royal Oak, Michigan, 48073
Study site
Saint Paul, Minnesota, 55102
Study site
Torrance, California, 90502
Study site
Washington D.C., District of Columbia, 20010
Canada2 sites
Study site
Montreal, Quebec, H1T 1C8
Study site
Ottawa, Ontario, K1Y 4W7
About this study
Official title: A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
- Conditions
- Atherosclerosis
- Being tested
- MLDL1278A, placebo, statin, stable dose
- Keywords
- BI-204
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLDL1278ADrug
Single intravenous dose
MLDL1278ADrug
Repeating intravenous dose
placeboDrug
Repeating intravenous dose
statin, stable doseDrug
Repeating oral dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MLDL1278A; Drug: statin, stable dose |
| B | Experimental | Not described Receives: Drug: MLDL1278A; Drug: statin, stable dose |
| C | Placebo comparator | Not described Receives: Drug: placebo; Drug: statin, stable dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TBR as measured by FDG-PET/CT
Measured: Baseline to Week 12
Secondary outcomes (2)
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A
Measured: Throughout study or until early discontinuation
Effects of MLDL1278A on inflammatory and metabolic biomarkers
Measured: Throughout study or until early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Responsible party
- Sponsor
- Investigators
- Joshua Lehrer-Graiwer, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258907
- Sponsor's protocol ID
- LDL4758g
- Other IDs
- GC01314
- Status last verified
- Nov 2016
- First submitted
- 10 Dec 2010
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER - Goal of Oxidized Ldl and Activated Macrophage Inhibition by Exposure to a Recombinant Antibody)
- ClinicalTrials.gov ID
- NCT01258907
- Acronym / sponsor ID
- LDL4758g
- Conditions
- Atherosclerosis
- Keywords
- BI-204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- BioInvent International AB
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- First posted
- 13 Dec 2010 (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.
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease with evidence of vascular inflammation, as quantified by FDG-PET/CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MLDL1278A, Drug: statin, stable dose |
| B | Experimental | Drug: MLDL1278A, Drug: statin, stable dose |
| C | Placebo comparator | Drug: placebo, Drug: statin, stable dose |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Evidence of qualifying vessel (carotid or aortic) plaque inflammation
- Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk
- Use of a stable dose of statin therapy for at least 6 weeks prior to screening. Patients must be capable of maintaining statin therapy at a current dose level from screening until the last follow-up visit.
- For patients taking angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents, use of a stable dose for at least 6 weeks prior to screening and capable of continuing with that dose for the duration of the study
Key exclusion criteria (12 listed)
- Occurrence of a cardiovascular event < 6 months prior to screening
- Pregnant, planning to become pregnant during the study, or breastfeeding
- Clinically significant abnormal laboratory values or abnormal ECG or vital signs
- History of anaphylactic reactions
- Newly discovered Type 2 diabetes mellitus (T2DM) (prior to study entry) or medical treatment for T2DM started < 3 months prior to study entry
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 |
|---|---|---|
| MLDL1278ASingle intravenous dose | Drug | A |
| MLDL1278ARepeating intravenous dose | Drug | B |
| placeboRepeating intravenous dose | Drug | C |
| statin, stable doseRepeating oral dose | Drug | A, B, C |
Primary outcome
Change in TBR as measured by FDG-PET/CT
Time frame: Baseline to Week 12
2 secondary outcomes
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A
Time frame: Throughout study or until early discontinuation
Effects of MLDL1278A on inflammatory and metabolic biomarkers
Time frame: Throughout study or until early discontinuation
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 2 Nov 2016.
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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.
Joshua Lehrer-Graiwer, M.D. study director
Genentech, Inc.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MLDL1278A and statin, stable dose in people with Atherosclerosis, run by Genentech, Inc. at 24 sites in 2 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 4 inclusion and 12 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 2 Nov 2016. 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, Canada. 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?
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?
Change in TBR as measured by FDG-PET/CT (time frame: Baseline to 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 2 Nov 2016.