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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 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

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Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
13,313 Total Patients Enrolled
6 Trials studying High Cholesterol
3,291 Patients Enrolled for High Cholesterol
Marc Ditmarsch, MDStudy DirectorNewAmsterdam Pharma
3 Previous Clinical Trials
9,662 Total Patients Enrolled
1 Trials studying High Cholesterol
108 Patients Enrolled for High Cholesterol
~171 spots leftby Oct 2024
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