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CompletedNCT06005597TANDEMUpdated Oct 8, 2025Results posted

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

A Phase 3 interventional study of Combination Therapy and Monotherapy obicetrapib in Dyslipidemias, Hypercholesterolemia and Familial Hypercholesterolemia, sponsored by NewAmsterdam Pharma. Completed at 45 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.

Sponsored by NewAmsterdam Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
407
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.

Read the detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 14 days. Afterwards patients will be randomized 1:1:1:1 to Obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination, obicetrapib 10 mg, ezetimibe 10 mg or placebo for a 84 day treatment period. After the treatment period, patients will have an end of study follow-up visit.

02

Conditions studied

  • Dyslipidemias
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
  • ASCVD
  • High Cholesterol

Keywords

  • obicetrapib
  • statin
  • LDL-C
  • cholesterol
  • atherosclerosis
03

In context

Dyslipidemias

1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.

This study's enrollment of 407 is above the median of 100 across 986 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have underlying HeFH and/or a history of ASCVD or multiple ASCVD risk factors
  • On maximally tolerated lipid-modifying therapy as an adjunct to a diet and lifestyle modifications
  • LDL-C ≥ 70 mg/dL
  • Triglycerides \< 500
  • Estimated ≥ 15 mL/min/1.73 m2

Exclusion criteria

Exclusion Criteria:

  • History of (NYHA) class III or IV heart failure of \<30%
  • Hospitalized for heart failure within the last 5 years
  • Myocardial infarction, stroke, non-elective coronary revascularization or hospitalization for unstable angina or chest pain in the last 3 months
  • Uncontrolled severe hypertension
  • Diagnosis of homozygous FH
  • Liver disease
  • ≥ 10.0% or fasting glucose ≥ 270 mg/dL
  • Thyroid-stimulating hormone >1.5 x (ULN)
  • History of
  • Creatinine kinase (CK) >3 X ULN
  • Alcohol abuse
  • Treatment with product
  • Treatment with gemfibrozil or ezetimibe
  • Previous participation in a trial evaluating obicetrapib
  • Known allergy to study drugs, placebo or in study drugs of placebo
  • Other condition that would interfere with the conduct of the study
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
407 participants (actual)

Study arms

  • Experimental
    Combination Therapy

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

    Combination Product: Combination Therapy · Other: Obicetrapib Placebo · Other: Ezetimibe Placebo

  • Experimental
    Monotherapy obicetrapib

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

    Drug: Monotherapy obicetrapib · Other: Combination Therapy placebo · Other: Ezetimibe Placebo

  • Active comparator
    Monotherapy ezetimibe

    once-daily ezetimibe 10 mg capsule, 2 placebo tablets

    Drug: Monotherapy ezetimibe · Other: Combination Therapy placebo · Other: Obicetrapib Placebo

  • Placebo comparator
    Placebo

    once-daily placebo tablets (2), placebo capsule

    Other: Combination Therapy placebo · Other: Obicetrapib Placebo · Other: Ezetimibe Placebo

Interventions

  • Combination productCombination Therapy

    tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination

    Also known as: Cholesteryl ester transfer protein (CETP) inhibitor, obicetrapib, ezetimibe

  • DrugMonotherapy obicetrapib

    tablet; 10mg obicetrapib

    Also known as: CETP inhibitor

  • DrugMonotherapy ezetimibe

    capsule; 10mg ezetimibe

  • OtherCombination Therapy placebo

    tablet; no active ingredient

  • OtherObicetrapib Placebo

    tablet; no active ingredient

  • OtherEzetimibe Placebo

    capsule; no active ingredient

06

What researchers measure

Primary outcomes

  1. Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C

    LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 84 Days

  2. Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C

    LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 84 Days

  3. Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C

    LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 84 Days

  4. Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C

    LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 84 Days

Secondary outcomes

  1. Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C

    LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.

    Time frame: 84 Days

  2. Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)

    LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.

    Time frame: 84 Days

  3. Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C

    LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.

    Time frame: 84 Days

  4. Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)

    LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.

    Time frame: 84 Days

  5. Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C

    LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.

    Time frame: 84 Days

  6. Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)

    LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.

    Time frame: 84 Days

  7. Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C

    LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg group.

    Time frame: 84 Days

  8. Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)

    LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group.

    Time frame: 84 Days

07

Results

Posted Oct 8, 2025

Participant flow

716 participants were screened: out of 716, 407 participants were randomized (1:1:1:1) (FDC therapy: Obicetrapib monotherapy: Ezetimibe monotherapy: placebo)

Participant flow — Overall Study
MilestoneFixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlacebo
Started102102101102
Completed1009999100
Not completed2322
Withdrew: Lost to follow-up1212
Withdrew: Death1110

Outcome measures

PrimaryEffect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C

LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
percent change from baselineFixed Dose CombinationPlacebo
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C-45.58 ± 3.4653.03 ± 3.564
Statistical analysis
  • Fixed Dose Combination vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -48.61 · 95% CI -58.33 to -38.89
PrimaryEffect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C

LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
percent change from baselineFixed Dose CombinationMonotherapy Ezetimibe
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C-45.58 ± 3.465-17.63 ± 3.497
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Ezetimibe · ANCOVA · p = <.0001 · Least squares (ls) means: -27.94 · 95% CI -37.53 to -18.35
PrimaryEffect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C

LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
percent change from baselineFixed Dose CombinationMonotherapy Obicetrapib
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C-45.58 ± 3.465-28.82 ± 3.484
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Obicetrapib · ANCOVA · p = 0.0007 · Least squares (ls) means: -16.76 · 95% CI -26.40 to -7.12
PrimaryEffect of Obicetrapib Monotherapy Compared to Placebo on LDL-C

LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
percent change from baselineMonotherapy ObicetrapibPlacebo
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C-28.82 ± 3.4843.03 ± 3.564
Statistical analysis
  • Monotherapy Obicetrapib vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -31.85 · 95% CI -41.64 to -22.07
SecondaryEffect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C

LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C
percent change from baselineFixed Dose CombinationPlacebo
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C-42.42 ± 2.9772.71 ± 3.017
Statistical analysis
  • Fixed Dose Combination vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -45.13 · 95% CI -53.43 to -36.84
SecondaryEffect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)

LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)
percent change from baselineFixed Dose CombinationPlacebo
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)-26.91 ± 2.4252.28 ± 2.466
Statistical analysis
  • Fixed Dose Combination vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -29.19 · 95% CI -35.99 to -22.40
SecondaryEffect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C

LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C
percent change from baselineMonotherapy ObicetrapibPlacebo
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C-27.19 ± 3.0102.71 ± 3.017
Statistical analysis
  • Monotherapy Obicetrapib vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -29.90 · 95% CI -38.28 to -21.53
SecondaryEffect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)

LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib monotherapy 10 mg group compared to the placebo group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)
percent change from baselineMonotherapy ObicetrapibPlacebo
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)-17.50 ± 2.4822.28 ± 2.466
Statistical analysis
  • Monotherapy Obicetrapib vs Placebo · ANCOVA · p = <.0001 · Least squares (ls) means: -19.78 · 95% CI -26.73 to -12.82
SecondaryEffect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C

LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C
percent change from baselineFixed Dose CombinationMonotherapy Ezetimibe
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C-42.42 ± 2.977-16.98 ± 3.006
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Ezetimibe · ANCOVA · p = <.0001 · Least squares (ls) means: -25.44 · 95% CI -33.67 to -17.22
SecondaryEffect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)

LS mean percent change in apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the ezetimibe monotherapy 10 mg group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)
percent change from baselineFixed Dose CombinationMonotherapy Ezetimibe
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)-26.91 ± 2.425-12.71 ± 2.495
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Ezetimibe · ANCOVA · p = <.0001 · Least squares (ls) means: -14.21 · 95% CI -21.06 to -7.36
SecondaryEffect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C

LS mean percent change in non-high-density lipoprotein cholesterol (Non-HDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10mg group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C
percent change from baselineFixed Dose CombinationMonotherapy Obicetrapib
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C-42.42 ± 2.977-27.19 ± 3.010
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Obicetrapib · ANCOVA · p = 0.0003 · Least squares (ls) means: -15.23 · 95% CI -23.53 to -6.93
SecondaryEffect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)

LS mean percent change in Apolipoprotein B (ApoB) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the obicetrapib monotherapy 10 mg group.

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)
percent change from baselineFixed Dose CombinationMonotherapy Obicetrapib
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)-26.91 ± 2.425-17.50 ± 2.482
Statistical analysis
  • Fixed Dose Combination vs Monotherapy Obicetrapib · ANCOVA · p = 0.007 · Least squares (ls) means: -9.42 · 95% CI -16.26 to -2.57

Adverse events

Collected over From first dose of study drug up to Week 16. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fixed Dose Combination1/102 (1%)3/102 (2.9%)30/102 (29.4%)
Monotherapy Obicetrapib1/102 (1%)6/102 (5.9%)62/102 (60.8%)
Monotherapy Ezetimibe1/101 (1%)7/101 (6.9%)35/101 (34.7%)
Placebo0/102 (0%)4/102 (3.9%)17/102 (16.7%)
Most frequent serious events
Showing 10 of 36
Most frequent serious events
EventFixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlacebo
Gastrointestinal haemorrhageGastrointestinal disorders0/1020/1022/1010/102
Angina unstableCardiac disorders1/1020/1021/1010/102
Atrial fibrillationCardiac disorders0/1020/1021/1010/102
Cardiogenic shockCardiac disorders0/1020/1021/1010/102
PneumoniaInfections and infestations0/1020/1021/1010/102
Septic shockInfections and infestations0/1020/1021/1010/102
Cerebrovascular accidentNervous system disorders0/1020/1021/1010/102
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/1020/1021/1010/102
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1020/1021/1010/102
Umbilical herniaGastrointestinal disorders0/1020/1021/1010/102
Most frequent other events
Showing 10 of 19
Most frequent other events
EventFixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlacebo
HypertensionVascular disorders4/1029/1022/1013/102
ArthralgiaMusculoskeletal and connective tissue disorders2/1027/1025/1013/102
HeadacheNervous system disorders1/1026/1021/1012/102
DiarrhoeaGastrointestinal disorders5/1023/1022/1010/102
NauseaGastrointestinal disorders1/1025/1021/1010/102
FatigueGeneral disorders4/1025/1020/1011/102
HypokalaemiaMetabolism and nutrition disorders0/1020/1024/1011/102
Upper respiratory tract infectionInfections and infestations4/1024/1023/1013/102
COVID-19Infections and infestations4/1021/1021/1011/102
BronchitisInfections and infestations2/1024/1020/1010/102

Baseline characteristics

Baseline Population is defined as all randomized participants

Age, Continuous
Age, Continuous(years)Fixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlaceboTotal
Mean67.3 ± 9.4366.7 ± 9.6467.6 ± 8.7166.1 ± 9.4766.9 ± 9.30
Sex: Female, Male
Sex: Female, Male(Participants)Fixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlaceboTotal
Female48334551177
Male54695651230
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Fixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlaceboTotal
Hispanic or Latino42129
Not Hispanic or Latino98100100100398
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlaceboTotal
American Indian or Alaska Native01102
Asian10315
Native Hawaiian or Other Pacific Islander01001
Black or African American1415131759
White86858284337
More than one race00000
Unknown or Not Reported10203
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)(mg/dL)Fixed Dose CombinationMonotherapy ObicetrapibMonotherapy EzetimibePlaceboTotal
Mean96.5 ± 28.80100.0 ± 35.3498.2 ± 31.0991.0 ± 25.8196.4 ± 30.26
08

Study locations

45 sites
  • East Valley Diabetes & Endocrinology
    Gilbert, Arizona 85297, United States
  • Jacksonville Center for Clinical Research
    Jacksonville, Florida 32216, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Centricity Research - Columbus
    Columbus, Georgia 31904, United States
  • Center for Advanced Research and Education
    Gainesville, Georgia 30501, United States
  • NSC Research
    Johns Creek, Georgia 30024, United States
  • North Georgia Clinical Research
    Woodstock, Georgia 30189, United States
  • Evanston Premier Healthcare Research LLC
    Skokie, Illinois 60077, United States
  • Cardiovascular Research of Northwest Indiana, LLC
    Munster, Indiana 46321, United States
  • Grace Research, LLC - Bossier City, LA
    Bossier City, Louisiana 71111, United States
  • Horizon Research Group of Opelousas
    Eunice, Louisiana 70535, United States
  • Maryland Cardiovascular Specialists
    Baltimore, Maryland 21229, United States
  • TidalHealth Peninsula Regional, Inc.
    Salisbury, Maryland 21804, United States
  • McClaren Bay Heart and Vascular
    Bay City, Michigan 49770, United States
  • Northern Pines Health Center
    Buckley, Michigan 49620, United States
  • Sparrow Clinical Research Institute
    Lansing, Michigan 48912, United States
  • Oakland Medical Research Center
    Troy, Michigan 48085, United States
  • CentraCare Heart & Vascular Center
    Saint Cloud, Minnesota 56303, United States
  • North Mississippi Medical Center
    Tupelo, Mississippi 38801, United States
  • St. Louis Heart and Vascular Cardiology
    St Louis, Missouri 63136, United States
  • Washington University School of Medicine
    St Louis, Missouri 63136, United States
  • Triad Internal Medicine
    Asheboro, North Carolina 27203, United States
  • Cary Research Group, LLC
    Cary, North Carolina 27518, United States
  • Novant Health Clinical Research, LLC
    Charlotte, North Carolina 27701, United States
  • Novant Health Heart and Vascular Institute
    Charlotte, North Carolina 28204, United States
  • Lucas Research, Inc
    Morehead City, North Carolina 28557, United States
  • Wilmington Health Associates
    Wilmington, North Carolina 28412, United States
  • Metabolic and Atherosclerosis Research Center
    Cincinnati, Ohio 45227, United States
  • Summit Research Group, LLC
    Stow, Ohio 44240, United States
  • Capital Area Research
    Camp Hill, Pennsylvania 17074, United States
  • Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
    Rapid City, South Dakota 57701, United States
  • Chattanooga Research & Medicine, PLLC
    Chattanooga, Tennessee 37404, United States
  • Cardiovascular Research of Knoxville
    Powell, Tennessee 37849, United States
  • PharmaTex Research, LLC
    Amarillo, Texas 79109, United States
  • Amarillo Heart Clinical Research Institute, Inc
    Amarillo, Texas 79124, United States
  • South Texas Clinical Research
    Corpus Christi, Texas 78404, United States
  • Diabetes and Thyroid Center of Fort Worth
    Fort Worth, Texas 76132, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Juno Research, LLC - Medical Center Office
    Houston, Texas 77054, United States
  • DM Clinical Research
    Houston, Texas 77375, United States
  • Wellness Clinical Research Associates
    McKinney, Texas 75069, United States
  • Northwest Houston Heart Center
    Tomball, Texas 77375, United States
  • Alpine Research Organization, Inc.
    Clinton, Utah 84015, United States
  • Spectrum Medical, Inc.
    Danville, Virginia 24541, United States
  • Hampton Roads Center for Clinical Research
    Suffolk, Virginia 23435, United States
09

References and documents

Publications

  • Sarraju A, Brennan D, Hayden K, Stronczek A, Goldberg AC, Michos ED, McGuire DK, Mason D, Tercek G, Nicholls SJ, Kling D, Neild AL, Kastelein J, Davidson M, Ditmarsch M, Nissen SE. Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 May 17;405(10491):1757-1768. doi: 10.1016/S0140-6736(25)00721-4. Epub 2025 May 7. PubMed 40347969 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Sep 2024, 6 months.

Results were first posted in Oct 2025, 1 year after primary completion.

Of 52 industry-sponsored phase 3 interventional studies under Dyslipidemias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 6 months is below that.

Counting every sponsor, half of 62 studies reached it within 22 months; a quarter within 12 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2023
First posted
Aug 22, 2023
StartActual
Mar 1, 2024
Primary completionActual
Sep 25, 2024
CompletionActual
Oct 16, 2024
Results first posted
Oct 8, 2025
Last update
Oct 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06005597
Lead sponsor
NewAmsterdam Pharma
Responsible party
Sponsor
First posted
Aug 22, 2023
Start date
Mar 1, 2024
Primary completion
Sep 25, 2024
Completion
Oct 16, 2024
Results posted
Oct 8, 2025
Last update
Oct 8, 2025

Study contacts

Marc Ditmarsch, MD
study director · NewAmsterdam Pharma

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: TA-8995

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Dyslipidemias →

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NewAmsterdam Pharma

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