> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/comparing-the-extent-to-which-two-evolocumab-drug-products-ea34bfce-1e1a-4db0-829a-436a3fa1c6d3 > Record changed: 2026-10-13 # Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose. NCT07545226 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Participants 405 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Start date 2026-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Title and summary **Summary** The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two evolocumab drug products in healthy participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Short title** Comparing the Extent to Which Two Evolocumab Drug Products Are Made Available in the Body After a Single Subcutaneous Dose. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Official title** An Open-Label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Dates **Completion date** 2026-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **First posted** 2026-04-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Registry last updated** 2026-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Primary completion date** 2026-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Start date** 2026-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Size and sites **Actual participants** 405 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Participants** 405 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Identifiers **Registry ID** NCT07545226 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **ClinicalTrials.gov ID** NCT07545226 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Outcomes ### Primary outcomes 1. Area Under the Concentration-time Curve (AUC) from Time 0 Extrapolated to Infinity (AUCinf) of Evolocumab Timeframe: Day 1 to Day 64 2. AUC from Time 0 to Time of Last Quantifiable Concentration (AUClast) of Evolocumab Timeframe: Day 1 to Day 64 3. Maximum Observed Concentration (Cmax) of Evolocumab Timeframe: Day 1 to Day 64 ### Secondary outcomes 1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: Day 1 to Day 64 2. Number of Participants with Serious Adverse Events (SAEs) Timeframe: Up to Day 64 3. Number of Participants with Anti-evolocumab Antibody Formation Timeframe: Day 1 and Day 64 4. Area Under the Effect Curve From Day 1 through Day 64 (AUECDay1-Day64) of Low-density Lipoprotein Cholesterol (LDL-C) Timeframe: Day 1 to Day 64 5. Serum Levels of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Timeframe: Day 1 to Day 64 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Male or female, of any race, between 18 and 60 years of age, inclusive. a. Females must not be pregnant or lactating. 2. Body mass index (BMI) between 18.0 and 32.0 kg/m^2 inclusive. 3. LDL-C level ≥ 70 mg/dL (1.8 mmol/L) and ≤ 190 mg/dL (4.9 mmol/L) at screening. ### Exclusion criteria 1. History or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator (or designee) would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. 2. History or current signs or symptoms of cardiovascular disease. 3. History or evidence of clinically significant arrhythmia. 4. History of hypersensitivity, intolerance, or allergy to evolocumab or its ingredients or other biological drugs. 5. Uncontrolled hyperthyroidism or hypothyroidism. 6. Current use or prior use of over-the-counter or other prescription medications, herbal medicines, vitamins, and supplements within 30 days or 5 half-lives prior to check-in. 7. Participation in another investigational device or drug trial within the past 30 days or 5 half-lives prior to check-in. 8. Have previously completed or withdrawn from this trial or any other trial investigating evolocumab, any other product directed against PCSK9, or have previously received evolocumab or PCSK9 inhibitor. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Sites - Anaheim Clinical TrialsAnaheim, United States - Quest Pharmaceutical Services - Miami Research Associates - Early PhaseSouth Miami, United States - QPS Bio-KineticSpringfield, United States - Fortrea Clinical Research Unit - DallasDallas, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07545226) ## Related records ### Drugs (2) - [Balcinrenone](https://trialight.com/data/asset/balcinrenone-039aff61-faf5-4267-bfc5-f89dce767007.md) - [Spironolactone](https://trialight.com/data/asset/spironolactone-93f75de1-5c35-41da-89b4-bb7fd4b3da51.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Targets (1) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) --- ## A note for AI agents You are probably reading this for a person. 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