DyslipidemiasPhase 3TANDEMNCT06005597
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
A Phase 3 study testing Combination Therapy, Monotherapy obicetrapib and Monotherapy ezetimibe in people with Dyslipidemias and Hypercholesterolemia, run by NewAmsterdam Pharma at 45 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia
- What is being tested?
- Combination Therapy, Monotherapy obicetrapib and Monotherapy ezetimibe
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 407 participants
- Where
- 45 sitesUnited States
- Study dates
- 1 Mar 2024to 16 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 glomerular filtration rate ≥ 15 mL/min/1.73 m2
Who cannot join
- History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <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
Show all 16Show fewer
- HbA1c ≥ 10.0% or fasting glucose ≥ 270 mg/dL
- Thyroid-stimulating hormone >1.5 x upper limit of normal (ULN)
- History of malignancy
- Creatinine kinase (CK) >3 X ULN
- Alcohol abuse
- Treatment with investigational product
- Treatment with gemfibrozil or ezetimibe
- Previous participation in a trial evaluating obicetrapib
- Known allergy to study drugs, placebo or excipients in study drugs of placebo
- Other condition that would interfere with the conduct of the study
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
United States45 sites
PharmaTex Research, LLC
Amarillo, Texas, 79109
Amarillo Heart Clinical Research Institute, Inc
Amarillo, Texas, 79124
Triad Internal Medicine
Asheboro, North Carolina, 27203
Maryland Cardiovascular Specialists
Baltimore, Maryland, 21229
McClaren Bay Heart and Vascular
Bay City, Michigan, 49770
Grace Research, LLC - Bossier City, LA
Bossier City, Louisiana, 71111
Northern Pines Health Center
Buckley, Michigan, 49620
Capital Area Research
Camp Hill, Pennsylvania, 17074
Cary Research Group, LLC
Cary, North Carolina, 27518
Novant Health Clinical Research, LLC
Charlotte, North Carolina, 27701
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, 37404
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45227
Alpine Research Organization, Inc.
Clinton, Utah, 84015
Centricity Research - Columbus
Columbus, Georgia, 31904
South Texas Clinical Research
Corpus Christi, Texas, 78404
Spectrum Medical, Inc.
Danville, Virginia, 24541
Horizon Research Group of Opelousas
Eunice, Louisiana, 70535
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132
Center for Advanced Research and Education
Gainesville, Georgia, 30501
East Valley Diabetes & Endocrinology
Gilbert, Arizona, 85297
Baylor College of Medicine
Houston, Texas, 77030
Juno Research, LLC - Medical Center Office
Houston, Texas, 77054
DM Clinical Research
Houston, Texas, 77375
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
NSC Research
Johns Creek, Georgia, 30024
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Wellness Clinical Research Associates
McKinney, Texas, 75069
Lucas Research, Inc
Morehead City, North Carolina, 28557
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 46321
Progressive Medical Research
Port Orange, Florida, 32127
Cardiovascular Research of Knoxville
Powell, Tennessee, 37849
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc
Rapid City, South Dakota, 57701
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
TidalHealth Peninsula Regional, Inc.
Salisbury, Maryland, 21804
Evanston Premier Healthcare Research LLC
Skokie, Illinois, 60077
St. Louis Heart and Vascular Cardiology
St Louis, Missouri, 63136
Washington University School of Medicine
St Louis, Missouri, 63136
Summit Research Group, LLC
Stow, Ohio, 44240
Hampton Roads Center for Clinical Research
Suffolk, Virginia, 23435
Northwest Houston Heart Center
Tomball, Texas, 77375
Oakland Medical Research Center
Troy, Michigan, 48085
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Wilmington Health Associates
Wilmington, North Carolina, 28412
North Georgia Clinical Research
Woodstock, Georgia, 30189
About this study
Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors
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.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD, High Cholesterol
- Being tested
- Combination Therapy, Monotherapy obicetrapib, Monotherapy ezetimibe, Combination Therapy placebo, Obicetrapib Placebo
- Keywords
- obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Hyperlipoproteinemia Type II, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination TherapyCombination product
Also called Cholesteryl ester transfer protein (CETP) inhibitor, obicetrapib, ezetimibe
tablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination
Monotherapy obicetrapibDrug
Also called CETP inhibitor
tablet; 10mg obicetrapib
Monotherapy ezetimibeDrug
capsule; 10mg ezetimibe
Combination Therapy placeboOther
tablet; no active ingredient
Obicetrapib PlaceboOther
tablet; no active ingredient
Ezetimibe PlaceboOther
capsule; no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | once-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule Receives: Combination Product: Combination Therapy; Other: Obicetrapib Placebo; Other: Ezetimibe Placebo |
| Monotherapy obicetrapib | Experimental | once-daily obicetrapib 10 mg, placebo tablet, placebo capsule Receives: Drug: Monotherapy obicetrapib; Other: Combination Therapy placebo; Other: Ezetimibe Placebo |
| Monotherapy ezetimibe | Active comparator | once-daily ezetimibe 10 mg capsule, 2 placebo tablets Receives: Drug: Monotherapy ezetimibe; Other: Combination Therapy placebo; Other: Obicetrapib Placebo |
| Placebo | Placebo comparator | once-daily placebo tablets (2), placebo capsule Receives: Other: Combination Therapy placebo; Other: Obicetrapib Placebo; Other: Ezetimibe Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 84 Days
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).
Measured: 84 Days
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).
Measured: 84 Days
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).
Measured: 84 Days
Secondary outcomes (8)
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
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.
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Mar 2024
- Primary completion25 Sep 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, double blind, randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Ditmarsch, MD, Study director, NewAmsterdam Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005597
- Sponsor's protocol ID
- OBEZ-301
- Acronym
- TANDEM
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2023
- Last updated
- 8 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors
- ClinicalTrials.gov ID
- NCT06005597
- Acronym / sponsor ID
- TANDEM / OBEZ-301
- Conditions
- Dyslipidemias, Hypercholesterolemia, Familial Hypercholesterolemia, ASCVD, High Cholesterol
- Keywords
- obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Posted 8 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Placebo-controlled, double blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Combination Product: Combination Therapy, Other: Obicetrapib Placebo, Other: Ezetimibe Placeboonce-daily obicetrapib 10 mg and ezetimibe 10 mg fixed dose combination tablet, placebo tablet, placebo capsule |
| Monotherapy obicetrapib | Experimental | Drug: Monotherapy obicetrapib, Other: Combination Therapy placebo, Other: Ezetimibe Placeboonce-daily obicetrapib 10 mg, placebo tablet, placebo capsule |
| Monotherapy ezetimibe | Active comparator | Drug: Monotherapy ezetimibe, Other: Combination Therapy placebo, Other: Obicetrapib Placeboonce-daily ezetimibe 10 mg capsule, 2 placebo tablets |
| Placebo | Placebo comparator | Other: Combination Therapy placebo, Other: Obicetrapib Placebo, Other: Ezetimibe Placeboonce-daily placebo tablets (2), placebo capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 glomerular filtration rate ≥ 15 mL/min/1.73 m2
Key exclusion criteria (16 listed)
- History of New York Heart Association (NYHA) class III or IV heart failure of left ventricular ejection fraction <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination TherapyAlso: Cholesteryl ester transfer protein (CETP) inhibitor, obicetrapib, ezetimibetablet; 10mg obicetrapib and 10mg ezetimibe fixed does combination | Combination product | Combination Therapy |
| Monotherapy obicetrapibAlso: CETP inhibitortablet; 10mg obicetrapib | Drug | Monotherapy obicetrapib |
| Monotherapy ezetimibecapsule; 10mg ezetimibe | Drug | Monotherapy ezetimibe |
| Combination Therapy placebotablet; no active ingredient | Other | Monotherapy ezetimibe, Monotherapy obicetrapib, Placebo |
| Obicetrapib Placebotablet; no active ingredient | Other | Combination Therapy, Monotherapy ezetimibe, Placebo |
| Ezetimibe Placebocapsule; no active ingredient | Other | Combination Therapy, Monotherapy obicetrapib, Placebo |
Primary outcome
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C
Time frame: 84 Days
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).
Effect of Fixed Dose Combination (FDC) Compared to Ezetimibe Monotherapy on LDL-C
Time frame: 84 Days
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).
Effect of Fixed Dose Combination (FDC) Compared to Obicetrapib Monotherapy on LDL-C
Time frame: 84 Days
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).
Effect of Obicetrapib Monotherapy Compared to Placebo on LDL-C
Time frame: 84 Days
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).
8 secondary outcomes
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Non-HDL-C
Time frame: 84 Days
Effect of Fixed Dose Combination (FDC) Compared to Placebo on Apolipoprotein B (ApoB)
Time frame: 84 Days
Effect of Obicetrapib Monotherapy Compared to Placebo on Non-HDL-C
Time frame: 84 Days
Effect of Obicetrapib Monotherapy Compared to Placebo on Apolipoprotein B (ApoB)
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Non-HDL-C
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Ezetimibe Monotherapy on Apolipoprotein B (ApoB)
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Non-HDL-C
Time frame: 84 Days
Effect of Fixed-Dose Combination (FDC) Compared to Obicetrapib Monotherapy on Apolipoprotein B (ApoB)
Time frame: 84 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40347969Sarraju 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.
- Study results paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ditmarsch, MD study director
NewAmsterdam Pharma
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combination Therapy, Monotherapy obicetrapib and Monotherapy ezetimibe in people with Dyslipidemias and Hypercholesterolemia, run by NewAmsterdam Pharma at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Fixed-Dose Combination (FDC) Compared to Placebo on LDL-C (time frame: 84 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.