Phase 2
N=36
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Hypercholesterolemia · Hyperlipoproteinemia Type II
Bottom Line
View on ClinicalTrials.gov: NCT02100839 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Number of Participants Who Incurred at Least One Treatment Emergent Event — 33; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AEM-28 (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LipimetiX Development, LLC
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Incurred at Least One Treatment Emergent Event |
33; 10 | — |
| PRIMARY Number of Participants Who Incurred Mild Treatment Emergent Adverse Events |
33; 10 | — |
| PRIMARY Number of Participants Who Incurred Moderate Treatment Emergent Events |
7; 0 | — |
| SECONDARY Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change |
-72.1; -0.33; -79.2; -0.58; -76.3; -0.35 | — |
Summary
The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated.
The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia.
AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia.
Eligibility Criteria
Inclusion Criteria
Single Ascending Dose (SAD) Study:
- Male or female non-smoker, ≥18 and ≤55 years of age, with BMI >18.5 and 18.5 and 2.5 mmol/L (97 mg/mL) at screening.
- On stable lipid lowering therapy for ≥ 8 weeks
- On stable diet for ≥ 12 weeks.
Exclusion Criteria
SAD Study:
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.
MAD Study:
- Significant health problems within 6 months prior to screening, which in the opinion of the Medical Sub-Investigator would prevent the subject from participating in the study, including but not limited to: unstable coronary heart disease; transient ischemic attack; stroke; revascularization procedure; uncontrolled hyperthyroidism; coagulation disorder; peptic ulcers or GI bleeding; significant disease of the central nervous system; liver or renal disease.
- History of allergic reactions to diphenhydramine, ranitidine, methylprednisone or other related drugs, or history of significant allergic or hypersensitivity reaction (e.g. angioedema) to any substance.
Data sourced from ClinicalTrials.gov (NCT02100839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.