Clinical trial NCT04753606: Randomized Study of Obicetrapib as an Adjunct to Statin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemias
High Cholesterol
Hypercholesterolemia
Keywords: obicetrapib
statin
LDL-C
cholesterol
atherosclerosis
Lead sponsor: NewAmsterdam Pharma
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo-controlled, double-blind, randomized
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8-weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8-Weeks
measure: LS Mean Percent Change Iin Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
timeFrame: 8-Weeks
measure: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8-Weeks
measure: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8-Weeks
measure: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
timeFrame: 8-Weeks
Secondary outcomes:
measure: Mean Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8-Weeks
measure: Median Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8-Week
measure: LS Mean Percent Change in Apolipoprotein B (ApoB)
timeFrame: 8-Weeks
measure: Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8-weeks
measure: Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8-Weeks
measure: LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: 8-Weeks
measure: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8-weeks
measure: Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8-Weeks
measure: LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: 8-Weeks
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Huntington Park
country: United States
facility: National Research Institute - Huntington Park
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Sacramento
country: United States
facility: Clinical Trials Research
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Troy
country: United States
facility: Oakland Medical Research Center
state: Michigan
city: Morehead City
country: United States
facility: Diabetes and Endocrinology Consultants, P.C.
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center
state: Ohio
city: Munroe Falls
country: United States
facility: Summit Research Group, LLC
state: Ohio
city: Rapid City
country: United States
facility: Monument Health Clinical Research
state: South Dakota
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Houston
country: United States
facility: Juno Research, LL
state: Texas
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
Study officials:
References:
citation: 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.