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

NCT06496243 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TA-8995-206
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Lp(a) change on combination therapy

  16 weeks from baseline; 8 weeks on combination therapy

Secondary Outcomes (1)

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

  8 weeks

Study Arms (1)

obicetrapib/evolocumab combination

EXPERIMENTAL

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

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

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

obicetrapib/evolocumab combination

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• HbA1c\>=10 or FPG \>=270 mg/dL
• CV events within 3 months of screen

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (1)

UPenn

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ashley Walker

CONTACT

919 641 5724; ashley.walker@newamsterdampharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)