Trial · NCT02100839

Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia

NCT02100839, Phase 1, Phase 2, Completed, LipimetiX Development, LLC; results first posted 2015-12-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia. Trials, record NCT02100839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02100839

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Trial

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

Title: Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
NCT number: NCT02100839
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 52 participants, actual
Lead sponsor: LipimetiX Development, LLC
Conditions: Hypercholesterolemia, Hyperlipoproteinemia Type II
Interventions: AEM-28, Normal Saline
First posted: 2014-04-01
Last updated: 2015-12-29
Results first posted: 2015-12-29

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Number of Participants Who Incurred at Least One Treatment Emergent Event	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated. Safety and tolerability data were reported using descriptive statistics.
Primary	Number of Participants Who Incurred Mild Treatment Emergent Adverse Events	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated. Safety and tolerability data were reported using descriptive statistics.
Primary	Number of Participants Who Incurred Moderate Treatment Emergent Events	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated. Safety and tolerability data were reported using descriptive statistics.
Secondary	Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57	Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants Who Incurred at Least One Treatment Emergent Event	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	participants	NUMBER
PRIMARY	Number of Participants Who Incurred Mild Treatment Emergent Adverse Events	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	Number of Participants	NUMBER
PRIMARY	Number of Participants Who Incurred Moderate Treatment Emergent Events	Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57	Number of Participants	NUMBER
SECONDARY	Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57	Max % Change Versus Baseline	MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Category	Value	Spread	Units
Number of Participants Who Incurred at Least One Treatment Emergent Event	AEM-28		33		participants
Number of Participants Who Incurred at Least One Treatment Emergent Event	Normal Saline		10		participants
Number of Participants Who Incurred Mild Treatment Emergent Adverse Events	AEM-28		33		Number of Participants
Number of Participants Who Incurred Mild Treatment Emergent Adverse Events	Normal Saline		10		Number of Participants
Number of Participants Who Incurred Moderate Treatment Emergent Events	AEM-28		7		Number of Participants
Number of Participants Who Incurred Moderate Treatment Emergent Events	Normal Saline		0		Number of Participants
Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	AEM-28	Part A: 3.54 mg/kg	-72.1	Standard Deviation 15.1	Max % Change Versus Baseline
Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	Normal Saline	Part A: 3.54 mg/kg	-0.33	Standard Deviation 0.17	Max % Change Versus Baseline
Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	AEM-28	Part B: 3.54 mg/kg	-79.2	Standard Deviation 13.5	Max % Change Versus Baseline
Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change	Normal Saline	Part B: 3.54 mg/kg	-0.58	Standard Deviation 0.31	Max % Change Versus Baseline

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Single Ascending Dose	STARTED	Apolipoprotein E Mimetic (AEM)-28	24
Single Ascending Dose	STARTED	Normal Saline	12
Single Ascending Dose	COMPLETED	Apolipoprotein E Mimetic (AEM)-28	24
Single Ascending Dose	COMPLETED	Normal Saline	12
Single Ascending Dose	NOT COMPLETED	Apolipoprotein E Mimetic (AEM)-28	0
Single Ascending Dose	NOT COMPLETED	Normal Saline	0
Multiple Ascending Dose	STARTED	Apolipoprotein E Mimetic (AEM)-28	13
Multiple Ascending Dose	STARTED	Normal Saline	3
Multiple Ascending Dose	COMPLETED	Apolipoprotein E Mimetic (AEM)-28	9
Multiple Ascending Dose	COMPLETED	Normal Saline	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events26

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	Events
other	Administration Site Reaction	General disorders	AEM-28	29	37	46
other	Administration Site Reaction	General disorders	Normal Saline	6	15	7
other	Headache	Nervous system disorders	AEM-28	9	37	12
other	Headache	Nervous system disorders	Normal Saline	0	15	0
other	Confusion	Injury, poisoning and procedural complications	AEM-28	2	37	2
other	Confusion	Injury, poisoning and procedural complications	Normal Saline	2	15	2
other	Fatigue	General disorders	AEM-28	1	37	1
other	Fatigue	General disorders	Normal Saline	2	15	2
other	Palpitations	Cardiac disorders	AEM-28	1	37	1
other	Palpitations	Cardiac disorders	Normal Saline	1	15	1

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AEM-28
Total, all-cause mortality	Normal Saline
Total, other adverse events	AEM-28	33	37
Total, other adverse events	Normal Saline	10	15
Total, serious adverse events	AEM-28	0	37
Total, serious adverse events	Normal Saline	0	15

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
AEM-28 vs Normal Saline: Number of Participants Who Incurred at Least One Treatment Emergent Event	Trial comparisons
AEM-28 vs Normal Saline: 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/NCT02100839

GET https://conductscience.org/api/trials/v1/NCT02100839/events?page=2

API reference For AI assistants