A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum Lipoprotein(a)

NCT04987320 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 20190095
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of Olpasiran in Chinese participants with elevated serum lipoprotein(a) (Lp\[a\]).

Conditions

Elevated Serum Lipoprotein(a)

Keywords

Elevated serum lipoprotein(a); Olpasiran

Outcome Measures

Primary Outcomes (1)

• Maximum Observed Concentration (Cmax) of Olpasiran

  The serum pharmacokinetic (PK) parameters of olpasiran were calculated using standard noncompartmental methods.

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

Secondary Outcomes (15)

• Area Under the Serum Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Olpasiran

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

• Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Olpasiran

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

• Time to Cmax (Tmax) of Olpasiran

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

• Apparent Terminal Elimination Half-life (T1/2) of Olpasiran

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

• Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Olpasiran

  Predose, 30 and 60 minutes, 2, 3, 6, 9, 12, 24, and 36 hours postdose on Day 1 and on study Days 3, 4, 7, 15, 29, 57, and 85

Study Arms (2)

Olpasiran Dose A

EXPERIMENTAL

Participants will be administered Olpasiran dose A as a subcutaneous injection.

Drug: Olpasiran

Olpasiran Dose B

EXPERIMENTAL

Participants will be administered Olpasiran dose B as a subcutaneous injection.

Drug: Olpasiran

Interventions

Olpasiran DRUG

Subcutaneous injection

Also known as: AMG 890

Olpasiran Dose A; Olpasiran Dose B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1: After written informed consent is obtained, subjects will provide a blood sample for a preliminary Lp(a) assessment to determine eligibility for Part 2 screening. Subjects with Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL) will be eligible to return to the CRU Part 2 screening. Subjects not eligible to return for Part 2 screening will be screen failed.
• Part 2: Eligible subjects will complete all remaining screening procedures and tests that establish eligibility within 40 days prior to the Day 1 visit.
• Part 1:
• Must be a resident in mainland China, Hong Kong, or Taiwan, and of Chinese Ancestry.
• Male or female subjects, between 18 and 60 years of age (inclusive) at the time of Screening.
• Screening serum Lp(a) ≥ 70 nmol/L (or approximately ≥ 27 mg/dL).
• Part 2:
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) as assessed by the Investigator (or designee).
• Body mass index between 18 and 32 kg/m\^2 (inclusive) at the time of Screening.
• Subjects who are on statin must be on a stable dose of the same statin for at least 6 weeks prior to enrollment, and plan to remain on a stable dose (i.e., no change in medication or dosage) for the duration of the study.
• Females must be of non-reproductive potential:
• a. Postmenopausal defined as: i. Age of ≥ 55 years with no menses for at least 12 months; OR ii. Age of \< 55 years with no menses for at least 12 months AND with a follicle stimulating hormone (FSH) level \> 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR b. History of hysterectomy; OR c. History of bilateral oophorectomy.

You may not qualify if:

• History or clinical evidence of peripheral neuropathy.
• Currently receiving apheresis as lipid reducing therapy.
• History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), or platelet count outside of the laboratory's normal reference range at screening. Subjects with PT and/or APTT values that are outside of the laboratory's normal reference range at screening may still be eligible to proceed to enrollment if the results are judged by the investigator in consultation with the study medical monitor to not be clinically significant.
• History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dL (6.9 mmol/L) at Screening.
• Use of any herbal medicines, vitamins or dietary supplements known to affect lipid metabolism (e.g. sigh oils \> 100mg/day, red yeast extract), within 30 days prior to dosing on Day 1 and for the duration of the study.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, HK, Hong Kong

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

olpasiran

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 3, 2021
• Study Start: July 28, 2021
• Primary Completion: November 12, 2021
• Study Completion: March 18, 2022
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

HK (1)