HyperlipidemiaPhase 2GAUSSNCT01375764

Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects

A Phase 2 study testing Evolocumab and Ezetimibe in people with Hyperlipidemia, run by Amgen at 42 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective dose of a statin. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hyperlipidemia
What is being tested?: Evolocumab and Ezetimibe
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: 160 participants
Where: 42 sitesin 8 countries
Study dates: 28 Jul 2011to 8 May 2012
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥ 18 to ≤ 75 years of age
On a statin or a low dose statin with stable dose for at least 4 weeks
Lipid lowering therapy has been stable prior to enrollment
Fasting triglycerides must be < 400 mg/dL.
Subject not at LDL-C goal

Who cannot join

New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia
Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
Uncontrolled hypertension

Trial locations and contacts

42 sites in 8 countries.

Country

City, postcode or hospital

42 sites in 8 countries

United States16 sites

Research Site
Akron, Ohio, 44311
Research Site
Anaheim, California, 92801
Research Site
Atlanta, Georgia, 30338
Research Site
Atlanta, Georgia, 30342
Research Site
Auburn, Maine, 04210
Research Site
Bristol, Tennessee, 37620
Research Site
Butte, Montana, 59701
Research Site
Chevy Chase, Maryland, 20815
Research Site
Cincinnati, Ohio, 45212
Research Site
Henderson, Nevada, 89052
Research Site
Las Vegas, Nevada, 89117
Research Site
Mission Viejo, California, 92691
Research Site
New York, New York, 10029
Research Site
Raleigh, North Carolina, 27609
Research Site
Savannah, Georgia, 31406
Research Site
Westlake Village, California, 91361

Other trials in United States

Spain8 sites

Research Site
Barcelona, Catalonia, 08036
Research Site
Barcelona, CataluÃ±a, 08036
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
L'Hospitalet de Llobregat, CataluÃ±a, 08907
Research Site
Reus, Catalonia, 43204
Research Site
Reus, CataluÃ±a, 43204
Research Site
Zaragoza, Aragon, 50009
Research Site
Zaragoza, AragÃ³n, 50009

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Sweden5 sites

Research Site
GÃ¶teborg, 411 36
Research Site
Gothenburg, 411 36
Research Site
Lund, 222 21
Research Site
Stockholm, 111 35
Research Site
Stockholm, 141 86

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Australia4 sites

Research Site
Camperdown, New South Wales, 2015
Research Site
Melbourne, Victoria, 3004
Research Site
Perth, Western Australia, 6000
Research Site
Sydney, New South Wales, 2022

Other trials in Australia

Canada3 sites

Research Site
Lachine, Quebec, H8S 2E4
Research Site
Saint Johnâ€™s, Newfoundland and Labrador, A1A 3R5
Research Site
St. John's, Newfoundland and Labrador, A1A 3R5

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Belgium2 sites

Research Site
Brussels, 1200
Research Site
Uccle, 1180

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Denmark2 sites

Research Site
Ballerup Municipality, 2750
Research Site
Vejle, 7100

Other trials in Denmark

Finland2 sites

Research Site
Helsinki, 00029
Research Site
OYS, 90029

Other trials in Finland

About this study

Official title: A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor

Conditions: Hyperlipidemia
Being tested: Evolocumab, Ezetimibe, Placebo to Evolocumab
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9), Cholesterol, High Cholesterol, Raised Cholesterol, Elevated Cholesterol, Statin intolerant, Hypercholesterolemia
Medical subject headings: Hyperlipidemias, Hypercholesterolemia, Autosomal Dominant, 3, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabBiological
Also called AMG 145, Repatha
Administered by subcutaneous injection
EzetimibeDrug
Also called Zetia
Administered orally once a day
Placebo to EvolocumabOther
Administered by subcutaneous injection

Study groups in NCT01375764
Study group	Role	What they receive
Ezetimibe	Active comparator	Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. Receives: Drug: Ezetimibe; Other: Placebo to Evolocumab
Evolocumab + Ezetimibe	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks. Receives: Biological: Evolocumab; Drug: Ezetimibe
Evolocumab 280 mg	Experimental	Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 350 mg	Experimental	Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab
Evolocumab 420 mg	Experimental	Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. Receives: Biological: Evolocumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Measured: Baseline and Week 12

Secondary outcomes (10)

Change From Baseline in LDL-C at Week 12
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Measured: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 20118 May 2012

First posted17 Jun 2011 (estimated)
Study start28 Jul 2011
Primary completion8 May 2012
Study completion8 May 2012

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 HyperlipidemiaStudies of the same condition, open and under way.
More trials run by AmgenThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01375764
Sponsor's protocol ID: 20090159
Acronym: GAUSS
Status last verified: Nov 2022
First submitted: 16 Jun 2011
Last updated: 7 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
PubMed 23128163

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor
ClinicalTrials.gov ID: NCT01375764
Acronym / sponsor ID: GAUSS / 20090159
Conditions: Hyperlipidemia
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9), Cholesterol, High Cholesterol, Raised Cholesterol, Elevated Cholesterol, Statin intolerant, Hypercholesterolemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 28 Jul 2011 (actual)
Primary completion: 8 May 2012 (actual)
Study completion: 8 May 2012 (actual)
First posted: 17 Jun 2011 (estimated)
Results: Posted 23 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
Ezetimibe	Active comparator	Drug: Ezetimibe, Other: Placebo to EvolocumabParticipants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab + Ezetimibe	Experimental	Biological: Evolocumab, Drug: EzetimibeParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
Evolocumab 280 mg	Experimental	Biological: EvolocumabParticipants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 350 mg	Experimental	Biological: EvolocumabParticipants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Evolocumab 420 mg	Experimental	Biological: EvolocumabParticipants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female ≥ 18 to ≤ 75 years of age
On a statin or a low dose statin with stable dose for at least 4 weeks
Lipid lowering therapy has been stable prior to enrollment
Fasting triglycerides must be < 400 mg/dL.
Subject not at LDL-C goal

Key exclusion criteria (5 listed)

New York Heart Association (NYHA) III or IV heart failure or known left ventricular ejection fraction < 30%
Uncontrolled cardiac arrhythmia
Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)
Uncontrolled hypertension

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
EvolocumabAlso: AMG 145, RepathaAdministered by subcutaneous injection	Biological	Evolocumab + Ezetimibe, Evolocumab 280 mg, Evolocumab 350 mg, Evolocumab 420 mg
EzetimibeAlso: ZetiaAdministered orally once a day	Drug	Evolocumab + Ezetimibe, Ezetimibe
Placebo to EvolocumabAdministered by subcutaneous injection	Other	Ezetimibe

Primary outcome

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.
Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.

10 secondary outcomes

Change From Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 23 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ezetimibe	33	31
Evolocumab + Ezetimibe	31	30
Evolocumab 280 mg	32	32
Evolocumab 350 mg	32	31
Evolocumab 420 mg	32	31

Primary outcome: Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Ezetimibe n = 32	Evolocumab 280 mg n = 32	Evolocumab 350 mg n = 31	Evolocumab 420 mg n = 32
Value	-14.76 (3.94)	-40.77 (3.96)	-42.58 (4.01)	-50.70 (3.98)

Ezetimibe vs Evolocumab 420 mg: LS Mean Treatment Difference: -35.94 (95% CI -44.08 to -27.80), p <0.001, ANCOVA
Ezetimibe vs Evolocumab 350 mg: LS Mean Treatment Difference: -27.82 (95% CI -35.97 to -19.67), p <0.001, ANCOVA
Ezetimibe vs Evolocumab 280 mg: LS Mean Tretament Difference: -26.01 (95% CI -34.08 to -17.93), p <0.001, ANCOVA

Population analysed: Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.

Primary outcome: Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: percent change

Measure	Ezetimibe n = 32	Evolocumab + Ezetimibe n = 30
Value	-15.70 (3.98)	-62.98 (4.22)

Ezetimibe vs Evolocumab + Ezetimibe: LS Mean Treatment Difference: -47.29 (95% CI -53.73 to -40.84), p <0.001, ANCOVA

Population analysed: Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ezetimibe	0 of 32 (0%)	16 of 32 (50%)	Not reported
Evolocumab 280 mg	2 of 32 (6.3%)	19 of 32 (59.4%)	Not reported
Evolocumab 350 mg	1 of 31 (3.2%)	10 of 31 (32.3%)	Not reported
Evolocumab 420 mg	1 of 32 (3.1%)	12 of 32 (37.5%)	Not reported
Evolocumab + Ezetimibe	0 of 30 (0%)	18 of 30 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23128163Sullivan D, Olsson AG, Scott R, Kim JB, Xue A, Gebski V, Wasserman SM, Stein EA. Effect of a monoclonal antibody to PCSK9 on low-density lipoprotein cholesterol levels in statin-intolerant patients: the GAUSS randomized trial. JAMA. 2012 Dec 19;308(23):2497-506. doi: 10.1001/jama.2012.25790.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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.

MD study director

Amgen

42 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evolocumab and Ezetimibe in people with Hyperlipidemia, run by Amgen at 42 sites in 8 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 5 inclusion and 5 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Spain, Sweden, Australia, Canada and 3 more countries. 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 23 Dec 2015). 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 Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 (time frame: Baseline and Week 12). The study lists 2 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 NCT01375764, 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 7 Nov 2022.