Phase 1
N=79
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT03626662 ↗Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Jan 2026
Primary outcome: Primary: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) — 5; 3; 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AMG 890 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) |
5; 3; 3; 5; 1; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Olpasiran |
11.7; 36.1; 74.9; 252; 421; 17.4 | — |
| SECONDARY Time to Reach Cmax (Tmax) of Olpasiran |
3.0; 3.0; 7.5; 4.5; 6.0; 3.0 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint (AUC0-last) of Olpasiran |
116; 352; 1020; 2830; 7800; 240 | — |
| SECONDARY Change From Baseline in Plasma Lp(a) Levels |
9.740; -17.820; -1.417; 9.412; 1.937; -6.438 | — |
| SECONDARY Percent Change From Baseline in Plasma Lp(a) Levels |
8.407; -13.943; -1.094; 8.295; 1.415; -4.027 | — |
Summary
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in approximately 80 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
Eligibility Criteria
Inclusion Criteria
- Men and women with ages between 18 and 70 years old, inclusive.
- Protocol-defined elevated plasma Lp(a) level.
- Body mass index (BMI) greater than or equal to 18 and less than or equal to 40 kg/m2, at screening.
- Women must be of non-reproductive potential.
- Other Inclusion criteria may apply
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study.
- Women who are lactating/breastfeeding or who plan to breastfeed while on study or through 90 days after receiving the last dose of investigational product (for subjects who withdraw prior to end of study).
- History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- History or clinical evidence of bleeding diathesis or any coagulation disorder.
- History or clinical evidence of peripheral neuropathy.
- Other Exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03626662). 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.