Randomized Study of Obicetrapib in Combination With Ezetimibe

NCT04770389 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TA-8995-303
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 9

Brief Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.

Conditions

Dyslipidemias; High Cholesterol; Hypercholesterolemia

Keywords

obicetrapib; statin; LDL-C; cholesterol; atherosclerosis

Outcome Measures

Primary Outcomes (6)

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

  Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

  8 weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

  Median percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

  8 weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [Friedewald]

  LS Mean percent change in LDL-C from baseline to Day 57; LDL-C determined using the Friedewald formula

  8 weeks

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

  Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

  8 weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

  Median percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

  8 weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib in Combination With Ezetimibe Compared to Placebo [PUC]

  LS Mean percent change in LDL-C from baseline to Day 57; LDL-C measured using preparative ultracentrifugation (PUC)

  8 weeks

Secondary Outcomes (27)

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

  8 weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

  8 weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [Friedewald]

  8 weeks

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]

  8 weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 57: Obicetrapib Monotherapy Compared to Placebo [PUC]

  8 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

placebo obicetrapib + placebo ezetimibe; once daily

Other: Placebo

Combination therapy

EXPERIMENTAL

5 mg obicetrapib + 10 mg ezetimibe; once daily

Drug: Obicetrapib 5mg; Drug: Ezetimibe 10mg

Obicetrapib monotherapy

EXPERIMENTAL

5 mg obicetrapib + placebo ezetimibe; once daily

Drug: Obicetrapib 5mg

Ezetimibe monotherapy

EXPERIMENTAL

placebo obicetrapib + 10 mg ezetimibe; once daily

Drug: Ezetimibe 10mg

Interventions

Obicetrapib 5mg DRUG

tablet

Also known as: CETP inhibitor

Combination therapy; Obicetrapib monotherapy

Ezetimibe 10mg DRUG

tablet

Also known as: Antihyperlipidemic

Combination therapy; Ezetimibe monotherapy

Placebo OTHER

tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding of the study procedures, willingness to adhere to the study schedules and diet, and agreement to participate in the study by giving written informed consent prior to Screening procedures
• Men or women 18 to 70 years of age, inclusive
• Women may be enrolled if all 3 of the following criteria are met:
• They are not pregnant;
• They are not breastfeeding; and
• They do not plan on becoming pregnant during the study
• Women of childbearing potential must have a negative urine pregnancy test at the Screening Visit.
• Women of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit. Men whose partners are of childbearing potential must agree to use an effective method of avoiding pregnancy from the Screening Visit to 90 days after the last visit.
• Fasting LDL-C levels \>2.5 mmol/L (\>100 mg/dL) and \<4.5 mmol/L (\<175 mg/dL) and TG levels \<4.5 mmol/L (\<400 mg/dL) (Visit 1) and
• Willingness to maintain a stable diet and physical activity level throughout the study

You may not qualify if:

• Body mass index \>= 40 kg/m2
• Participation in another clinical study involving an investigational or marketed drug within 30 days prior to the Screening Visit
• Currently taking any lipid-altering therapy
• Any clinical manifestation of atherosclerotic CVD or any evidence of ischemic coronary disease present on the 12-lead ECG at the Screening Visit
• Diagnosis of type 1 or type 2 diabetes mellitus; or HbA1c \>= 6.5% at the Screening visit if no prior diagnosis of diabetes mellitus
• Uncontrolled hypertension ie, sitting systolic blood pressure \>160 mmHg and/or sitting diastolic blood pressure \>90 mmHg taken as the average of triplicate measurements.
• History of torsades de pointes
• Estimated glomerular filtration rate \<60 mL/min calculated using the Chronic Kidney Disease Epidemiology Collaboration equation
• Hepatic dysfunction as evidenced by any laboratory abnormality as follows: gamma- glutamyl transferase, alanine aminotransferase, or aspartate aminotransferase \>2 x ULN, or total bilirubin \>1.5 x ULN
• Anemia, defined as hemoglobin concentration \<11 g/dL for males and hemoglobin concentration \<9 g/dL for females
• History of malignancy within the past 5 years, with the exception of non-melanoma skin cancers
• Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study
• Known ezetimibe or CETP inhibitor allergy or intolerance

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (9)

Clinical Trials Research

Lincoln, California, 95648, United States

Location

Evanston Premier Healthcare Research LLC

Evanston, Illinois, 60201, United States

Location

Juno Research, LLC - Medical Center Office

Houston, Texas, 77054, United States

Location

Huisartsen Praktijk A.M.N. Zijtregto

Rotterdam, 3037 AN, Netherlands

Location

Huisartsen Praktijk van Soerland

Rotterdam, 3067 GJ, Netherlands

Location

Medisch Centrum Thomsonplein

The Hague, 2565 KN, Netherlands

Location

Huisartsen Praktijk Rambharose

The Hague, 2572 GM, Netherlands

Location

Huisartsen Praktijk Broekman

Zwijndrecht, 3333 GZ, Netherlands

Location

Dokters van Nederhoven

Zwijndrecht, 3334 SB, Netherlands

Location

Related Publications (1)

• Pirillo A, Catapano AL. The two faces of cholesteryl ester transfer protein inhibitors. Curr Opin Lipidol. 2025 Dec 1;36(6):318-325. doi: 10.1097/MOL.0000000000001017. Epub 2025 Oct 13.

  PMID: 41190670 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe; Hypolipidemic Agents

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Lipid Regulating Agents; Therapeutic Uses

Results Point of Contact

• Title: Study Director
• Organization: NewAmsterdam Pharma

study.director@newamsterdampharma.com

+1(305) 627-3081

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo tablet made to resemble active
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-Controlled, Double-Blind, Randomized

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: February 23, 2021
• Primary Completion: May 7, 2021
• Study Completion: June 30, 2021
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); NL (6)