NCT01375777 (MENDEL) is a Phase 2 clinical trial of Evolocumab in Hyperlipidemia, sponsored by Amgen.

Who is sponsoring NCT01375777?

NCT01375777 is sponsored by Amgen.

What drugs are being tested in NCT01375777?

Interventions in NCT01375777: Evolocumab, Ezetimibe, Placebo to Evolocumab.

What condition does NCT01375777 study?

NCT01375777 studies Hyperlipidemia.

Is NCT01375777 still recruiting?

NCT01375777 is currently completed. Last updated 8 November 2022.

Are results published for NCT01375777?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-08 · How we verify

NCT01375777: MENDEL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels

Completed Phase 2 Results posted Last updated 8 November 2022

What this trial tests

Phase 2 trial testing Evolocumab in Hyperlipidemia in 411 participants. Completed in 2 March 2012.

Timeline

6 July 2011

Primary endpoint
2 March 2012

2 March 2012

Quick facts

Lead sponsor	Amgen
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	411
Start date	6 July 2011
Primary completion	2 March 2012
Estimated completion	2 March 2012
Sites	58 locations across Denmark, Belgium, Canada, Australia, United States

Drugs / interventions tested

Evolocumab (EVOLOCUMAB) — full drug profile →
Ezetimibe (EZETIMIBE) — full drug profile →
Placebo to Evolocumab — full drug profile →

Conditions studied

Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Amgen — full company profile →

Who can join

Adults 18 to 75, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

LDL-C was measured using ultracentrifugation.

Group	Value	95% CI
Placebo Q2W	-3.71	± 2.66
Placebo Q4W	4.54	± 2.64
Ezetimibe	-14.26	± 2.60
Evolocumab 70 mg Q2W	-40.98	± 2.64
Evolocumab 105 mg Q2W	-43.87	± 2.60
Evolocumab 140 mg Q2W	-50.93	± 2.66
Evolocumab 280 mg Q4W	-39.02	± 2.57
Evolocumab 350 mg Q4W	-43.20	± 2.57
Evolocumab 420 mg Q4W	-47.98	± 2.58

Change From Baseline in LDL-C at Week 12 Secondary · Baseline and Week 12

LDL-C was measured using ultracentrifugation.

Group	Value	95% CI
Placebo Q2W	-3.4	± 3.9
Placebo Q4W	7.3	± 3.7
Ezetimibe	-19.2	± 3.6
Evolocumab 70 mg Q2W	-55.7	± 3.7
Evolocumab 105 mg Q2W	-66.0	± 3.7
Evolocumab 140 mg Q2W	-69.3	± 3.6
Evolocumab 280 mg Q4W	-53.5	± 3.6
Evolocumab 350 mg Q4W	-56.7	± 3.6
Evolocumab 420 mg Q4W	-65.0	± 3.6

Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 Secondary · Baseline and Week 12

Group	Value	95% CI
Placebo Q2W	-2.89	± 2.40
Placebo Q4W	-0.25	± 2.30
Ezetimibe	-15.53	± 2.36
Evolocumab 70 mg Q2W	-37.95	± 2.38
Evolocumab 105 mg Q2W	-39.68	± 2.34
Evolocumab 140 mg Q2W	-48.04	± 2.40
Evolocumab 280 mg Q4W	-37.94	± 2.24
Evolocumab 350 mg Q4W	-42.14	± 2.24
Evolocumab 420 mg Q4W	-47.36	± 2.25

Percent Change From Baseline in Apolipoprotein B at Week 12 Secondary · Baseline and Week 12

Group	Value	95% CI
Placebo Q2W	-0.33	± 2.28
Placebo Q4W	0.19	± 2.28
Ezetimibe	-11.17	± 2.19
Evolocumab 70 mg Q2W	-32.66	± 2.26
Evolocumab 105 mg Q2W	-36.20	± 2.23
Evolocumab 140 mg Q2W	-44.52	± 2.28
Evolocumab 280 mg Q4W	-33.04	± 2.21
Evolocumab 350 mg Q4W	-37.73	± 2.21
Evolocumab 420 mg Q4W	-42.29	± 2.22

Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 Secondary · Baseline and Week 12

Group	Value	95% CI
Placebo Q2W	-1.21	± 2.17
Placebo Q4W	-3.39	± 2.11
Ezetimibe	-16.65	± 1.99
Evolocumab 70 mg Q2W	-30.07	± 2.15
Evolocumab 105 mg Q2W	-33.13	± 2.12
Evolocumab 140 mg Q2W	-38.70	± 2.17
Evolocumab 280 mg Q4W	-32.07	± 2.05
Evolocumab 350 mg Q4W	-34.60	± 2.05
Evolocumab 420 mg Q4W	-39.97	± 2.06

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 Secondary · Baseline and Week 12

Group	Value	95% CI
Placebo Q2W	2.03	± 2.40
Placebo Q4W	0.14	± 2.46
Ezetimibe	-12.35	± 2.33
Evolocumab 70 mg Q2W	-32.80	± 2.38
Evolocumab 105 mg Q2W	-38.30	± 2.35
Evolocumab 140 mg Q2W	-48.13	± 2.40
Evolocumab 280 mg Q4W	-36.10	± 2.39
Evolocumab 350 mg Q4W	-40.43	± 2.39
Evolocumab 420 mg Q4W	-45.33	± 2.40

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Q2W

Serious: 0/45 (0%)

Deaths: —

Placebo Q4W

Serious: 0/45 (0%)

Deaths: —

Ezetimibe

Serious: 0/45 (0%)

Deaths: —

Evolocumab 70 mg Q2W

Serious: 0/45 (0%)

Deaths: —

Evolocumab 105 mg Q2W

Serious: 1/46 (2%)

Deaths: —

Evolocumab 140 mg Q2W

Serious: 1/45 (2%)

Deaths: —

Evolocumab 280 mg Q4W

Serious: 0/45 (0%)

Deaths: —

Evolocumab 350 mg Q4W

Serious: 1/45 (2%)

Deaths: —

Evolocumab 420 mg Q4W

Serious: 0/45 (0%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Placebo Q2W	Placebo Q4W	Ezetimibe	Evolocumab 70 mg Q2W	Evolocumab 105 mg Q2W	Evolocumab 140 mg Q2W	Evolocumab 280 mg Q4W	Evolocumab 350 mg Q4W	Evolocumab 420 mg Q4W
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—
IgA nephropathy	Renal and urinary disorders	—	—	—	—	—	—	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Placebo Q2W	Placebo Q4W	Ezetimibe	Evolocumab 70 mg Q2W	Evolocumab 105 mg Q2W	Evolocumab 140 mg Q2W	Evolocumab 280 mg Q4W	Evolocumab 350 mg Q4W	Evolocumab 420 mg Q4W
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—
Injection site induration	General disorders	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—
Sinus congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Appendicitis, Humerus fracture, IgA nephropathy.

Data from ClinicalTrials.gov NCT01375777 adverse events section.

Sponsor's own description

The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study.
Koren MJ, Scott R, Kim JB, Knusel B, et al · · 2012 · cited 271× · PMID 23141812 · DOI 10.1016/s0140-6736(12)61771-1
Antibodies to watch in 2014.
Reichert JM. · · 2014 · cited 82× · PMID 24284914 · DOI 10.4161/mabs.27333
Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies.
Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, et al · · 2020 · cited 28× · PMID 32114889 · DOI 10.1161/jaha.119.014129
Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia.
Rosenson RS, Jacobson TA, Preiss D, Djedjos CS, et al · · 2016 · cited 27× · PMID 27240673 · DOI 10.1007/s10557-016-6666-1
Effect of evolocumab on cholesterol synthesis and absorption.
Peach M, Xu R, Fitzpatrick D, Hamilton L, et al · · 2016 · cited 14× · PMID 27707817 · DOI 10.1194/jlr.p071704
Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies.
Daviglus ML, Ferdinand KC, López JAG, Wu Y, et al · · 2021 · cited 12× · PMID 33325247 · DOI 10.1161/jaha.120.016839
Systemic evaluation of inclisiran on the risk of new-onset diabetes and hyperglycemia compared to evolocumab and atorvastatin.
Li F, Ye H, Chen L, Ma Y, et al · · 2025 · cited 1× · PMID 40735483 · DOI 10.3389/fphar.2025.1554631
Effects of Alirocumab and Evolocumab on Cardiovascular Mortality and LDL-C: Stratified According to the Baseline LDL-C Levels.
Ma H, Ma W, Liu Y, Chen L, et al · · 2025 · cited 1× · PMID 40351695 · DOI 10.31083/rcm26980

Verify or expand the search:

Other trials of Evolocumab

Trials testing the same drug.

NCT06081153 — Mechanistic Clinical Trial of PCSK9 Inhibition for AAA · EARLY_PHASE1 · not yet recruiting
NCT06858332 — Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia · recruiting
NCT06284564 — A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients Wi · Phase 2 · active not recruiting
NCT06134635 — Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke · unknown
NCT05974345 — In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established C · completed

Other recruiting trials for Hyperlipidemia

Currently open trials in the same condition.

NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
NCT07216482 — A Clinical Study of Enlicitide in Participants With High Cholesterol (MK-0616-037) · Phase 3 · recruiting
NCT06615609 — "Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft · NA · recruiting
NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
NCT06603363 — Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT · NA · recruiting

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01375777 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 8 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01375777.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01375777: MENDEL

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Evolocumab

Other recruiting trials for Hyperlipidemia

Other Amgen trials

Verify against primary sources