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Combination Therapy for High Cholesterol (TANDEM Trial)

Phase 3

Recruiting

Research Sponsored by NewAmsterdam Pharma

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84-days

Awards & highlights

TANDEM Trial Summary

"This trial is testing a new medication called obicetrapib in combination with ezetimibe to see if it is effective and safe for people with high cholesterol or heart disease. Participants will be

Who is the study for?

This trial is for adults with high cholesterol, specifically those with a genetic condition called HeFH or who have heart disease or are at high risk for it. They should already be on the strongest dose of cholesterol medicine they can handle and still have LDL (bad) cholesterol over 70 mg/dL or HDL (good) cholesterol over 100 mg/dL.Check my eligibility

What is being tested?

The study tests a new combo pill containing Obicetrapib and Ezetimibe against placebos in people taking their usual cholesterol meds. It's to see if this pill helps lower bad cholesterol more effectively. Participants won't know if they're getting the real treatment or a dummy pill.See study design

What are the potential side effects?

Possible side effects include typical reactions to lipid-lowering drugs like muscle pain, liver problems, increased blood sugar levels, and digestive issues. Since it's double-blind, even researchers don't know who gets what which helps measure true side effects.

TANDEM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~84-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 84-days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Effect of combination therapy compared to ezetimibe 10 mg monotherapy on LDL-C

Effect of combination therapy compared to obicetrapib 10 mg monotherapy on LDL-C

Effect of combination therapy compared to placebo on LDL-C

Secondary outcome measures

Effect of combination therapy compared compared to ezetimibe 10 mg monotherapy on non-HDL-C

Effect of combination therapy compared to ezetimibe 10 mg monotherapy on ApoB

Effect of combination therapy compared to obicetrapib 10 mg monotherapy on ApoB

+3 more

TANDEM Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Monotherapy obicetrapibExperimental Treatment3 Interventions

once-daily obicetrapib 10 mg, placebo tablet, placebo capsule

Group II: Combination TherapyExperimental Treatment3 Interventions

once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule

Group III: Monotherapy ezetimibeActive Control3 Interventions

once-daily ezetimibe 10 mg capsule, 2 placebo tablets

Group IV: PlaceboPlacebo Group3 Interventions

once-daily placebo tablets (2), placebo capsule

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Combination Therapy

2011

Completed Phase 1

~690

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor

14 Previous Clinical Trials

12,772 Total Patients Enrolled

6 Trials studying High Cholesterol

3,291 Patients Enrolled for High Cholesterol

Marc Ditmarsch, MDStudy DirectorNewAmsterdam Pharma

3 Previous Clinical Trials

9,121 Total Patients Enrolled

1 Trials studying High Cholesterol

108 Patients Enrolled for High Cholesterol

Frequently Asked Questions

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

What is the current number of individuals being enrolled in this research investigation?

"To proceed with the research, 400 eligible participants are needed. The trial will be overseen by NewAmsterdam Pharma and carried out at multiple locations such as The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute in Charlotte, North carolina, and the Metabolic and Atherosclerosis Research Center in Cincinnati, Ohio."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Information from clinicaltrials.gov confirms that this research is currently enrolling participants. It was first made available on March 1, 2024, and the most recent update was also on March 1, 2024."

Answered by AI

Are there numerous locations within the state where this clinical trial is being conducted?

"Among the 43 sites participating in this trial are institutions like The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute in Charlotte, Metabolic and Atherosclerosis Research Center in Cincinnati, as well as Cardiovascular Research of Northwest Indiana, LLC in Munster."

Answered by AI

What is the safety profile of Combination Therapy for individuals?

"On a 1 to 3 scale, the safety evaluation for Combination Therapy by our team at Power is rated as 3 due to its Phase 3 trial status. This indicates existing efficacy data and robust safety data from multiple assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

2024. "Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005597.

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