Dyslipidemias
Conditions
Brief summary
The goal of this open label 16 week trial is to evaluate Lp(a) levels for patients with elevated Lp(a) being treated with obicetrapib and obiceptrapib/evolocumab Patients will: Have baseline Lp(a) tested at randomization Take 10mg/dL obiceptrapib daily for 8 weeks and have Lp(a) tested at Week 8 Take 10 mg/dL obicetrapib daily/evolocumab 140 every other week for 8 weeks and have Lp(a) retested at Week 16
Interventions
DRUGobicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks
10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks
Sponsors
NewAmsterdam Pharma
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
8 weeks on 10 mg daily obicetrapid followed by 8 weeks on obicetrapib 10 mg daily/Repatha 140 mg SC every 2 weeks combination therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Lp(a): \>=50 mg/dL (\>=125 nmol/L) for cohort 1 (FILLED) and Lp(a) \>= 20 mg/dL (\>= 50 nmol/L) to \<50 mg/dL (\< 125 nmol/L) for cohort 2 * LDL-C \>70 mg/dL * TG \< 400mg/dL (\<4.52 mmol/L)
Exclusion criteria
* HbA1c\>=10 or FPG \>=270 mg/dL * CV events within 3 months of screen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]). | 16 weeks from baseline; 8 weeks on combination therapy | Lp(a) change on combination therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of obicetrapib alone on Lp(a). | 8 weeks | Lp(a) change on obicetrapib |
Countries
United States
Contacts
CONTACTAshley Walker
Outcome results
None listed