Trial · NCT02739984

Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia

NCT02739984, Phase 3, Completed, Amgen; results first posted 2018-08-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia. Trials, record NCT02739984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02739984

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
NCT number: NCT02739984
Status: Completed
Phases: Phase 3
Enrollment: 424 participants, actual
Lead sponsor: Amgen
Conditions: Hypercholesterolemia, Mixed Dyslipidemia, Type 2 Diabetes
Interventions: Evolocumab, Placebo to Evolocumab
First posted: 2016-04-15
Last updated: 2018-08-31
Other registries' IDs: eudract:2015-004711-21
Results first posted: 2018-08-31

Source ClinicalTrials.gov

Registered outcomes22

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and Weeks 10 and 12
Primary	Percent Change From Baseline in LDL-C at Week 12	Baseline and week 12
Secondary	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Change From Baseline in LDL-C at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Non-HDL-C at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Apolipoprotein B at Week 12	Baseline and week 12
Secondary	Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12
Secondary	Percent Change From Baseline in Total Cholesterol at Week 12	Baseline and week 12

1 to 10 of 22Source ClinicalTrials.gov

See all 22 registered outcomes

Outcomes22

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and Weeks 10 and 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
PRIMARY	Percent Change From Baseline in LDL-C at Week 12	Baseline and week 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in LDL-C at Week 12	Baseline and week 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	mg/dL	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Non-HDL-C at Week 12	Baseline and week 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Apolipoprotein B at Week 12	Baseline and week 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12	Baseline and weeks 10 and 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Total Cholesterol at Week 12	Baseline and week 12	Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).	percent change	LEAST_SQUARES_MEAN

1 to 10 of 22Source ClinicalTrials.gov

See all 22 outcomes

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo	-0.84	Standard Error 1.76	percent change
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Evolocumab	-64.98	Standard Error 1.31	percent change
Percent Change From Baseline in LDL-C at Week 12	Placebo	-1.14	Standard Error 1.92	percent change
Percent Change From Baseline in LDL-C at Week 12	Evolocumab	-54.28	Standard Error 1.42	percent change
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Placebo	-8.3	Standard Error 2.2	mg/dL
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	Evolocumab	-75.5	Standard Error 1.6	mg/dL
Change From Baseline in LDL-C at Week 12	Placebo	-8.6	Standard Error 2.3	mg/dL
Change From Baseline in LDL-C at Week 12	Evolocumab	-64.4	Standard Error 1.7	mg/dL
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Placebo	-0.05	Standard Error 1.63	percent change
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12	Evolocumab	-56.62	Standard Error 1.21	percent change

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	143
Overall Study	STARTED	Evolocumab	281
Overall Study	Received Study Drug	Placebo	141
Overall Study	Received Study Drug	Evolocumab	280
Overall Study	COMPLETED	Placebo	138
Overall Study	COMPLETED	Evolocumab	279
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	Evolocumab	2

Source ClinicalTrials.gov

Adverse events50

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	141
other	Diarrhoea	Gastrointestinal disorders	Evolocumab	6	280
other	Pharyngitis	Infections and infestations	Placebo	3	141
other	Pharyngitis	Infections and infestations	Evolocumab	0	280
other	Urinary tract infection	Infections and infestations	Placebo	2	141
other	Urinary tract infection	Infections and infestations	Evolocumab	6	280
other	Viral upper respiratory tract infection	Infections and infestations	Placebo	4	141
other	Viral upper respiratory tract infection	Infections and infestations	Evolocumab	5	280
other	Diabetes mellitus	Metabolism and nutrition disorders	Placebo	5	141
other	Diabetes mellitus	Metabolism and nutrition disorders	Evolocumab	8	280

1 to 10 of 50Source ClinicalTrials.gov

See all 50 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	141
Total, all-cause mortality	Evolocumab	1	280
Total, other adverse events	Placebo	19	141
Total, other adverse events	Evolocumab	37	280
Total, serious adverse events	Placebo	2	141
Total, serious adverse events	Evolocumab	14	280

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30953107	DERIVED	PubMed
36435949	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Evolocumab vs Placebo: deaths from any cause	Trial comparisons
Evolocumab vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02739984

GET https://conductscience.org/api/trials/v1/NCT02739984/registered?page=2

API reference For AI assistants