Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels
Phase 2
Recruiting
- Conditions
- Dyslipidemias
- Interventions
- Registration Number
- NCT06496243
- Lead Sponsor
- NewAmsterdam Pharma
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Lp(a) >50 mg/dL
- LDL-C >70 mg/dL
- TG < 400mg/dL
Read More
Exclusion Criteria
- HbA1c>=10 or FPG >=270 mg/dL
- CV events within 3 months of screen
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description obicetrapib/evolocumab combination obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks obicetrapib 10 mg/dL daily for 8 weeks followed by obicetrapib 10 mg/dL daily + evolocumab 140 mg/dL every other week for 8 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method To evaluate the effect of obicetrapib alone on Lp(a). 8 weeks Lp(a) change on obicetrapib
Trial Locations
- Locations (1)
UPenn
🇺🇸Philadelphia, Pennsylvania, United States