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Laropiprant

Phase 3

Hypercholesterolemia | Small molecule | Metabolic |Merck & Company, Inc.|Trials Updated: Nov 21, 2019

Laropiprant development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2011

Laropiprant target and mechanism

ModalitySmall molecule

Also known as MK-0524

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment732

FDA Designations

No designations recorded

Laropiprant clinical trials

Laropiprant · 3 trials · 3 indications

Phase 3 1Phase 1 2
NCT00536510Effect of MK0524A on Cholesterol Levels (0524A-048)Hypercholesterolemia
COMPLETED646 Analytics
PHASE3COMPLETED
Effect of MK0524A on Cholesterol Levels (0524A-048)
HypercholesterolemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) After 12 Weeks
12 weeks

Low Density Lipoprotein Cholesterol (LDL-C) after 12 weeks is calculated as the difference between week 12 measure and baseline measure divided by baseline measure \*100

Change in Clinician's Erythema Assessment (CEA) Scale Score from Baseline
Baseline and Week 4
Urinary 11-dehydrothromboxane B2 (11-dTxB2)
On Day 7 across the 24-hour urinary collection period.

The creatinine-normalized urine levels of 11-dTxB2 on Day 7 following a 7 day course of daily dosing in the overall 24 hour collection interval.

Secondary Endpoints

Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) After 12 Weeks
12 weeks
Change in Patient Self Assessment (PSA) Score from Baseline
Baseline and Week 4
Prostaglandin I Metabolite (PGI-M)
On Day 7 across the 24-hour urinary collection period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALlaropiprant/niacin (MK0524A)
2PLACEBO_COMPARATORplacebo
LaropiprantEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
AEXPERIMENTALER niacin/laropiprant + Placebo to laropiprant
BACTIVE_COMPARATORER niacin + Placebo to laropiprant
CEXPERIMENTALlaropiprant + Placebo to ER niacin/laropiprant
DPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
laropiprant/niacin (MK0524A)DRUGTreatment Period 1: one 20mg/1g tablet laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization
Comparator: placeboDRUGTreatment Period 1: one 20mg/1g tablet placebo to laropiprant/niacin once daily for 4 weeks Treatment Period 2: two 20mg/1g tablets of placebo to laropiprant/niacin once daily for 8 weeks. All patients will receive placebo for a 4 week run-in period before randomization.
LaropiprantDRUGOne 100-mg tablet orally once daily for 4 weeks
Placebo for LaropiprantDRUGOne tablet orally once daily for 4 weeks
Comparator: niacin + laropiprantDRUGER niacin 2 g/laropiprant 40 mg tablet once daily for 7 days
Comparator: niacinDRUGER niacin 2 g tablet once daily for 7 days
Comparator: laropiprantDRUGlaropiprant 40 mg once daily for 7 days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient is male or female between 18 and 70 years of age * Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Exclusion Criteria: * Patient has a history of not being able to take niacin or niacin-containin...

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Frequently asked questions about Laropiprant

What is Laropiprant used for?

Laropiprant is a small molecule being studied for the treatment of hypercholesterolemia and rosacea. It is an investigational drug developed by Merck & Company, Inc. (MRK) and is currently in Phase 1 clinical development for these indications.

What does Laropiprant target?

Laropiprant is a small molecule that has been studied for its effects on cholesterol levels in patients with hypercholesterolemia and hyperlipidemia. Its specific molecular target has not been disclosed in available clinical trial information.

Who makes Laropiprant?

Laropiprant is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company has conducted clinical trials to evaluate the drug's safety and efficacy.

What phase is Laropiprant in?

Laropiprant is currently in Phase 1 clinical development. It has completed a Phase 1 trial in participants with moderate to severe erythematotelangiectatic rosacea. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Laropiprant in?

Laropiprant has been studied in two completed clinical trials. NCT00536510 was a Phase 3 study evaluating its effect on cholesterol levels in 646 participants with hypercholesterolemia and hyperlipidemia. NCT01451619 was a Phase 1 study in 60 participants with moderate to severe erythematotelangiectatic rosacea.

Is Laropiprant the same as MK-0524?

Laropiprant is also known as MK-0524. In clinical trials, the drug has been referred to by both names, including in a study of participants with rosacea (MK-0524-155) and a study of cholesterol levels (0524A-048).