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CETP Inhibitor

Obicetrapib 10 mg for Metabolism of Lipids

Phase 1

Recruiting

Led By Archna Bajaj, MD

Research Sponsored by NewAmsterdam Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has fasting plasma triglyceride level ≤ 400 mg/dL, at Screening Visit 1A and is on atorvastatin or rosuvastatin for a minimum of 4 weeks, or at the Statin Optimization Visit 1B if subject has switched to, or initiated, 10 mg daily rosuvastatin for a minimum of 4 weeks.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8-12 week

Awards & highlights

Study Summary

This trial aims to study the effect of obicetrapib (a medication) on the rate at which a protein called apolipoprotein B100 is broken down in low-density lipoprotein

Who is the study for?

This trial is for men and women aged 18-75 who are in good health as determined by a doctor, have had a stable weight for at least 6 weeks, and have a BMI between >18.5 and ≤40 kg/m2. Women must not be pregnant or breastfeeding. Participants should have normal triglyceride levels and been on certain statin medications for at least 4 weeks.Check my eligibility

What is being tested?

The study tests the effect of Obicetrapib (10 mg) on how quickly the body breaks down 'apo B100' in LDL cholesterol—often called bad cholesterol. The goal is to see if this drug can help improve lipid metabolism.See study design

What are the potential side effects?

Potential side effects of Obicetrapib may include changes in liver enzymes, muscle pain or weakness, abdominal pain, constipation or diarrhea, nausea, headache, dizziness or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My fasting triglyceride level is ≤ 400 mg/dL and I've been on specific cholesterol medications for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8-12 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8-12 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8-12 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment with obicetrapib (10 mg) on the fractional catabolic rate (FCR) of apolipoprotein (apo) B100 in low-density lipoprotein (LDL).

Secondary outcome measures

Treatment with obicetrapib (10 mg) on the production rate (PR) of apolipoprotein(a), or apo(a), in Lp(a).

Other outcome measures

Treatment with obicetrapib (10 mg) on the FCR of total apolipoprotein (apo) B100 in plasma.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Obicetrapib 10 mgExperimental Treatment1 Intervention

10 mg tablets

Group II: Obicetrapib placeboPlacebo Group1 Intervention

identical matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obicetrapib

2022

Completed Phase 2

~440

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor

14 Previous Clinical Trials

13,152 Total Patients Enrolled

University of PennsylvaniaOTHER

2,005 Previous Clinical Trials

42,882,263 Total Patients Enrolled

Archna Bajaj, MDPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"Indeed, as per the details available on clinicaltrials.gov, this clinical trial is currently seeking eligible participants. The study was posted for the first time on December 1st, 2023 and underwent its latest revision on January 20th, 2024. For the successful execution of this trial, researchers aim to recruit a total of 20 patients from a single designated site."

Answered by AI

Is the clinical trial open to participants who have surpassed their 25th year of age?

"Applicants above the age of 18 and below 75 years old are eligible for recruitment in this clinical trial."

Answered by AI

What are the potential risks associated with consuming Obicetrapib at a dosage of 10 mg for individuals?

"Based on the classification of this trial as Phase 1, our team at Power has assigned a safety rating of 1 to Obicetrapib 10 mg. This indicates that there is limited available data regarding its safety and efficacy."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently in the recruitment phase. The initial posting date for the trial was December 1st, 2023 and it underwent its most recent update on January 20th, 2024. For this study, a total of 20 patients will be enrolled at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigating the Effect of Obicetrapib on Lipoprotein Metabolism

2023. "Investigating the Effect of Obicetrapib on Lipoprotein Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972278.