Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

Hypercholesterolemia Clinical Trial

— ROSE  

Official title:

A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to High-Intensity Statin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753606
• Other study ID #: TA-8995-201
• Status: Completed
• Phase: Phase 2
• Start date: February 18, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: NewAmsterdam Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up and a 15-week PK follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 30, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• LDL-C > 70 mg/dL and TG < 400 mg/dL,

• Treated with a high-intensity statin therapy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dyslipidemias
• High Cholesterol
• Hypercholesterolemia

Intervention

Drug:
• Obicetrapib
tablets

Locations

Country	Name	City	State
United States	Pinnacle Research Group	Anniston	Alabama
United States	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio
United States	IACT Health	Columbus	Georgia
United States	Evanston Premier Healthcare Research LLC	Evanston	Illinois
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Juno Research, LL	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Diabetes and Endocrinology Consultants, P.C.	Morehead City	North Carolina
United States	Summit Research Group, LLC	Munroe Falls	Ohio
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Health Concepts	Rapid City	South Dakota
United States	Monument Health Clinical Research	Rapid City	South Dakota
United States	Clinical Trials Research	Sacramento	California
United States	Oakland Medical Research Center	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
NewAmsterdam Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean Percent Change in Apolipoprotein B (ApoB)	Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8-Weeks
Secondary	Median Percent Change in Apolipoprotein B (ApoB)	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8-Week
Secondary	LS Mean Percent Change in Apolipoprotein B (ApoB)	Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.	8-Weeks
Secondary	Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8-weeks
Secondary	Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8-Weeks
Secondary	LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)	LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group	8-Weeks
Secondary	Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.	8-weeks
Secondary	Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.	8-Weeks
Secondary	LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)	LS mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.	8-Weeks