Obicetrapib History and Updates

62 events · 2021 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026.

FDA Approvals

Label Revisions

Trial Milestones

Pivotal Publications

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Obicetrapib since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (3)

2025

Results postedObicetrapib/Ezetimibe Combo Reduces LDL-C by 45.58% in Dyslipidemia Trial· Oct 8, 2025
Results postedObicetrapib Phase 3 Trial Reduces LDL-C by 29.94% in Dyslipidemia· Sep 19, 2025
Results postedObicetrapib Phase 3 Trial Reduces LDL-C in Heterozygous Familial…· Jun 11, 2025

Upcoming & expected milestones

Primary completionSep 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06982508

Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 2 primary completion: NCT06496243

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

Primary completionNov 30, 2026· ClinicalTrials.gov

Phase 3 primary completion: NCT05202509

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

Primary completionNov 30, 2027· ClinicalTrials.gov

Phase 3 primary completion: NCT06305559

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Primary completionMar 31, 2028· ClinicalTrials.gov

Phase 3 primary completion: NCT07219602

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommen

Past events

2025

Trial startedDec 11, 2025· ClinicalTrials.gov

Phase 3 trial started: NCT07219602

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommen

Trial registeredOct 22, 2025· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT07219602

A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommen

Results postedOct 8, 2025· ClinicalTrials.gov

Trial results posted: NCT06005597

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Results postedSep 19, 2025· ClinicalTrials.gov

Trial results posted: NCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Trial startedSep 9, 2025· ClinicalTrials.gov

Phase 2 trial started: NCT06982508

Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers

Results postedJun 11, 2025· ClinicalTrials.gov

Trial results posted: NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Trial registeredMay 21, 2025· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06982508

Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers

2024

Trial startedDec 2, 2024· ClinicalTrials.gov

Phase 2 trial started: NCT06496243

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

Results postedNov 19, 2024· ClinicalTrials.gov

Trial results posted: NCT05161715

Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

Primary completionNov 12, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06547359

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Trial startedOct 1, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06547359

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Results postedSep 27, 2024· ClinicalTrials.gov

Trial results posted: NCT05421078

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Primary completionSep 26, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT05972278

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

Primary completionSep 26, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Primary completionSep 25, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT06005597

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Trial registeredAug 9, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06547359

A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects

Trial registeredJul 11, 2024· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT06496243

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

Results postedJul 3, 2024· ClinicalTrials.gov

Trial results posted: NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Results postedJun 11, 2024· ClinicalTrials.gov

Trial results posted: NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Primary completionMay 28, 2024· ClinicalTrials.gov

Phase 3 primary completion: NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Trial startedMay 16, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06305559

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Primary completionApr 25, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06250205

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

Results postedApr 24, 2024· ClinicalTrials.gov

Trial results posted: NCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

Primary completionMar 12, 2024· ClinicalTrials.gov

Phase 1 primary completion: NCT06048302

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

Trial registeredMar 12, 2024· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06305559

A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque

Trial startedMar 1, 2024· ClinicalTrials.gov

Phase 3 trial started: NCT06005597

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Trial registeredFeb 8, 2024· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06250205

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

Trial startedFeb 5, 2024· ClinicalTrials.gov

Phase 1 trial started: NCT06250205

Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

2023

Primary completionDec 2, 2023· ClinicalTrials.gov

Phase 1 primary completion: NCT06081166

A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

Trial startedDec 1, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT05972278

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

Trial startedNov 30, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06048302

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

Trial startedNov 11, 2023· ClinicalTrials.gov

Phase 1 trial started: NCT06081166

A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

Trial registeredOct 13, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06081166

A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin

Trial registeredSep 21, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT06048302

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

Trial registeredAug 22, 2023· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT06005597

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

Trial registeredAug 2, 2023· ClinicalTrials.gov

Phase 1 trial registered on ClinicalTrials.gov: NCT05972278

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

Primary completionMay 9, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05161715

Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

Primary completionMar 24, 2023· ClinicalTrials.gov

Phase 2 primary completion: NCT05421078

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

2022

Primary completionAug 12, 2022· ClinicalTrials.gov

Phase 2 primary completion: NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Trial startedJul 25, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Trial startedJun 27, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05421078

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Trial registeredJun 21, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05425745

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

Trial registeredJun 16, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05421078

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

Trial startedMar 9, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Trial registeredMar 4, 2022· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

Trial startedFeb 7, 2022· ClinicalTrials.gov

Phase 3 trial started: NCT05202509

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

Trial registeredJan 21, 2022· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05202509

Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

Trial startedJan 12, 2022· ClinicalTrials.gov

Phase 2 trial started: NCT05161715

Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

2021

Trial registeredDec 17, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT05161715

Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease

Trial startedDec 15, 2021· ClinicalTrials.gov

Phase 3 trial started: NCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Trial registeredDec 3, 2021· ClinicalTrials.gov

Phase 3 trial registered on ClinicalTrials.gov: NCT05142722

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Primary completionMay 24, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Primary completionMay 7, 2021· ClinicalTrials.gov

Phase 2 primary completion: NCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

Trial registeredFeb 25, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

Trial startedFeb 23, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04770389

Randomized Study of Obicetrapib in Combination With Ezetimibe

Trial startedFeb 18, 2021· ClinicalTrials.gov

Phase 2 trial started: NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Trial registeredFeb 15, 2021· ClinicalTrials.gov

Phase 2 trial registered on ClinicalTrials.gov: NCT04753606

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.