Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

NCT04753606 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TA-8995-201
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 19

Brief Summary

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin 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) [Friedewald]

  Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group.LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

  8-weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

  Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

  8-Weeks

• LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

  LS mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. \[Friedewald\] LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC),

  8-Weeks

• Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

  Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  8-Weeks

• Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

  Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

  8-Weeks

• LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

  LS Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured directly by preparative ultracentrifugation (PUC).

  8-Weeks

Secondary Outcomes (9)

• Mean Percent Change in Apolipoprotein B (ApoB)

  8-Weeks

• Median Percent Change in Apolipoprotein B (ApoB)

  8-Week

• LS Mean Percent Change in Apolipoprotein B (ApoB)

  8-Weeks

• Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  8-weeks

• Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)

  8-Weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

once-daily placebo

Drug: Obicetrapib

obicetrapib 5 mg

EXPERIMENTAL

once-daily obicetrapib

Drug: Obicetrapib

obicetrapib 10 mg

EXPERIMENTAL

once-daily obicetrapib

Drug: Obicetrapib

Interventions

Obicetrapib DRUG

tablets

Also known as: CETP inhibitor

Placebo; obicetrapib 10 mg; obicetrapib 5 mg

Eligibility Criteria

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

You may qualify if:

• LDL-C \> 70 mg/dL and TG \< 400 mg/dL,
• Treated with a high-intensity statin therapy

You may not qualify if:

• BMI \> 40 kg/m
• Significant cardiovascular disease
• HbA1c \> 10%
• Uncontrolled hypertension
• Active muscle disease
• GFR \< 60 ml/min
• Hepatic dysfunction
• Anemia
• History of malignancy
• Alcohol abuse
• Treatment with investigational product
• Treatment with PCSK9
• Clinically significant condition
• Known CETP inhibitor allergy

Sponsors & Collaborators

• NewAmsterdam Pharma: lead

Study Sites (19)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

National Research Institute - Huntington Park

Huntington Park, California, 90255, United States

Location

National Research Institute - Wilshire

Los Angeles, California, 90057, United States

Location

Clinical Trials Research

Sacramento, California, 95821, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Ocala Cardiovascular Research

Ocala, Florida, 34474, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

IACT Health

Columbus, Georgia, 31904, United States

Location

Evanston Premier Healthcare Research LLC

Evanston, Illinois, 60201, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Oakland Medical Research Center

Troy, Michigan, 48085, United States

Location

Diabetes and Endocrinology Consultants, P.C.

Morehead City, North Carolina, 28557, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58104, United States

Location

Metabolic and Atherosclerosis Research Center

Cincinnati, Ohio, 45227, United States

Location

Summit Research Group, LLC

Munroe Falls, Ohio, 44262, United States

Location

Monument Health Clinical Research

Rapid City, South Dakota, 57701, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Juno Research, LL

Houston, Texas, 77040, United States

Location

Manassas Clinical Research Center

Manassas, Virginia, 20110, United States

Location

Related Publications (1)

• Nicholls SJ, Ditmarsch M, Kastelein JJ, Rigby SP, Kling D, Curcio DL, Alp NJ, Davidson MH. Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial. Nat Med. 2022 Aug;28(8):1672-1678. doi: 10.1038/s41591-022-01936-7. Epub 2022 Aug 11.

  PMID: 35953719 RESULT

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Atherosclerosis

Condition Hierarchy (Ancestors)

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

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 9, 2021
• First Posted: February 15, 2021
• Study Start: February 18, 2021
• Primary Completion: May 24, 2021
• Study Completion: August 30, 2021
• Last Updated: July 12, 2024
• Results First Posted: June 11, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)