CompletedPhase 2

Randomized Study of Obicetrapib as an Adjunct to Statin Therapy

United States120 participantsStarted 2021-02-18

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 8-weeks

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

Timeframe: 8-Weeks

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

Timeframe: 8-Weeks

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

Timeframe: 8-Weeks

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

Timeframe: 8-Weeks

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

Timeframe: 8-Weeks

Trial details

NCT IDNCT04753606

SponsorNewAmsterdam Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-24

Results submitted2024-05-13

View on ClinicalTrials.gov More Dyslipidemias trials