ClinicalTrials.gg
RecruitingNCT06496243VINCENTUpdated Apr 9, 2026

Impact of Obicetrapib and Obicetrapib Plus Repatha on Lp(a) Levels

A Phase 2 interventional study of obicetrapib 10 mg + obicetrapib/evolocumab 140 mg Q 2 weeks in Dyslipidemias, sponsored by NewAmsterdam Pharma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-09.

Sponsored by NewAmsterdam Pharma · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Dyslipidemias

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03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's planned enrollment of 69 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • >=10 or FPG >=270 mg/dL
  • CV events within 3 months of screen
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
69 participants (estimated)

Study 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

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

Interventions

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

    Drug page: TA-8995

    10 mg obicetrapib for 8 weeks followed by 10 mg obicetrapib/ 140 mg evolocumab (every 2 weeks) combination for 8 weeks

    Also known as: Repatha

06

What researchers measure

Primary outcomes

  1. To evaluate the effect of evolocumab in combination with obicetrapib on lipoprotein (a) (Lp[a]).

    Lp(a) change on combination therapy

    Time frame: 16 weeks from baseline; 8 weeks on combination therapy

Secondary outcomes

  1. To evaluate the effect of obicetrapib alone on Lp(a).

    Lp(a) change on obicetrapib

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Nov 2026, 23 months after the start.

Of 35 industry-sponsored phase 2 interventional studies under Dyslipidemias, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 18. This study's planned 23 months is above that.

Counting every sponsor, half of 43 studies reached it within 13 months; a quarter within 7 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2024
First posted
Jul 11, 2024
StartActual
Dec 2, 2024
Primary completionEst.
Nov 2026
CompletionEst.
Feb 2027
Last update
Apr 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06496243
Lead sponsor
NewAmsterdam Pharma
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Dec 2, 2024
Primary completion
Nov 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Apr 9, 2026

Study contacts

Ashley Walker
Contact
ashley.walker@newamsterdampharma.com
919 641 5724

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: TA-8995

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