Phase 2
Completed N=64
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)
Elevated Lipoprotein(a)
Source: ClinicalTrials.gov NCT02160899 ↗
Enrolled (actual)
64
Serious AEs
4.7%
Results posted
Dec 2019
Primary outcomePrimary: Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99 — -3.7; -44.5; -70.0; -5.6 percent change — p=<.001
Summary
The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to participants with high lipoprotein(a) for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99 |
-3.7; -44.5; -70.0; -5.6; -71.6 | <.001 sig |
| PRIMARY Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
23; 4; 21; 2; 2; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females aged 18-65 inclusive
- Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (defined as 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the laboratory involved)
- Males must be surgically sterile, abstinent or if engaged in sexual relations with a female of child-bearing potential, the participant must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 16 weeks after the last dose of Study Drug
- Body mass index (BMI) ≤40 kg/m2
- Lipoprotein(a) ≥50 and 499 mL within 8 weeks of screening
- Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study
Data sourced from ClinicalTrials.gov (NCT02160899). 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. Informational only — not medical advice.