Recruiting
Phase 2

Obicetrapib & Repatha

Sponsor:

NewAmsterdam Pharma

Code:

NCT06496243

Conditions

Dyslipidemias

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks

Study Details

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

Conditions

Dyslipidemias

Study ID

NCT06496243

Start date

Dec 2, 2024

Status verified date

Apr, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

69 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: obicetrapib/evolocumab combination

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

Interventions

obicetrapib 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

Primary outcome measure

  • To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]). [ Time Frame: 16 weeks from baseline; 8 weeks on combination therapy ]

Central Contacts and Locations

Central contacts

Ashley Walker

919 641 5724ashley.walker@newamsterdampharma.com

Locations

UPenn

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Archna Bajaj

More Information

Sponsor

NewAmsterdam Pharma

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NewAmsterdam Pharma on 2026-04-09.