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CompletedNCT05425745BROOKLYNUpdated Jun 11, 2025Results posted

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

A Phase 3 interventional study of Obicetrapib and Placebo in Dyslipidemias, High Cholesterol and Hypercholesterolemia, sponsored by NewAmsterdam Pharma. Completed at 96 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

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

Phase
Phase 3
Study type
Interventional
Enrollment
354
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies testing TA-8995 in Dyslipidemias — 1 open to participants now, 1 under way, none of them phase 3. TA-8995 · Dyslipidemias.

Enrollment
4th of 14
354 · median 116
Started
2022
with 2 others
Phase 3
3 of 14
none open now
Registered
12th of 14
by date
Lead sponsor
8 of 14
NewAmsterdam Pharma

Among the 14 studies testing TA-8995 in Dyslipidemias, this one is the 4th largest by enrollment, is one of 3 that started in 2022, is one of 3 in phase 3, and was the 12th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

Phase 26 · 1 open
Phase 15 · 0 open
Phase 3this study3 · 0 open

By the year they started

First in 2008; this study’s year is marked. 3 started in 2022.

Tested beside TA-8995

Ezetimibe2

Size and results

Median enrollment 116 across the 14 interventional studies. Of the 13 that completed or were terminated, 7 (54%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies testing TA-8995 in Dyslipidemias, or all of them as a file.
02

Study summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).

Read the detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with HeFH 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 to placebo or 10 mg obicetrapib for an 365-day treatment period. After the treatment period, participants will have an end-of-study follow-up visit.

03

Conditions studied

  • Dyslipidemias
  • High Cholesterol
  • Hypercholesterolemia
  • Familial Hypercholesterolemia
  • Lipid Metabolism Disorder
  • Metabolic Disease
  • Lipid Metabolism, Inborn Errors
  • Genetic Disease, Inborn
  • Hyperlipoproteinemias

Keywords

  • Obicetrapib
  • BROOKLYN
  • Cholesteryl ester transfer protein (CETP) inhibitor
  • Heterozygous Familial Hypercholesterolemia (HeFH)
  • LDL-C
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 a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
  • Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
  • Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)

Exclusion criteria

Exclusion Criteria:

  • class II or IV heart failure or last known \< 30%;
  • Hospitalized for heart failure within 5 years prior to Screening
  • Major adverse cardiac event (MACE) within 3 months prior to Screening;
  • ≥10%, or fasting glucose
  • Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
  • Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization
Terms in these criteria, in plain language(3)

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.

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.

05

Study design

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

Study arms

  • Placebo comparator
    Placebo

    one placebo tablet once daily

    Drug: Placebo

  • Experimental
    Obicetrapib 10 mg

    one 10 mg Obicetrapib tablet once daily

    Drug: Obicetrapib

Interventions

  • DrugObicetrapib

    10 mg Obicetrapib tablet

    Also known as: CETP-inhibitor

  • DrugPlacebo

    placebo tablet made to resemble active

06

What researchers measure

Primary outcomes

  1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

    LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 84 Days

Secondary outcomes

  1. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

    LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[Martin/Hopkins\]. LDL-C value was calculated using the Martin/Hopkins equation unless TG \>= 400 mg/dL or LDL-C \<= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).

    Time frame: 180 Days

  2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

    LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

    Time frame: 365 Days

  3. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

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

    Time frame: 84 Days

  4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group

    Time frame: 180 Days

  5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group

    Time frame: 365 Days

  6. Percent Change in Non-HDL-C From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 84 Days

  7. Percent Change in Non-HDL-C From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 180 Days

  8. Percent Change in Non-HDL-C From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 365 Days

  9. Percent Change in HDL-C From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 84 Days

  10. Percent Change in HDL-C From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 180 Days

  11. Percent Change in HDL-C From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

    Time frame: 365 Days

  12. Percent Change in Lp(a) From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group

    Time frame: 84 Days

  13. Percent Change in Lp(a) From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group

    Time frame: 365 Days

  14. Percent Change in Total Cholesterol From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group

    Time frame: 84 Days

  15. Percent Change in Total Cholesterol From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group

    Time frame: 180 Days

  16. Percent Change in Total Cholesterol From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group

    Time frame: 365 Days

  17. Percent Change in Triglycerides From Baseline to Day 84

    LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group

    Time frame: 84 Days

  18. Percent Change in Triglycerides From Baseline to Day 180

    LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group

    Time frame: 180 Days

  19. Precent Change in Triglycerides From Baseline to Day 365

    LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group

    Time frame: 365 days

07

Results

Posted Jun 11, 2025

Participant flow

513 patients were screened: out of 513, 354 participants were randomized: 236 participants to the obicetrapib 10 mg group and 118 participants to the placebo group

Participant flow — Overall Study
MilestonePlaceboObicetrapib 10 mg
Started118236
Completed110226
Not completed810
Withdrew: Withdrawal of consent33
Withdrew: Death23
Withdrew: Lost to follow-up12
Withdrew: Adverse event01
Withdrew: Did not return for end of study visit01
Withdrew: End of study visit completed by phone10
Withdrew: Subject decision10

Outcome measures

PrimaryPercent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]

LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC].25 ± 2.480-36.05 ± 1.769
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 · Least squares (ls) means: -36.31 · 95% CI -42.22 to -30.39
SecondaryPercent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]

LS mean percent change from baseline to Day 180 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[Martin/Hopkins\]. LDL-C value was calculated using the Martin/Hopkins equation unless TG \>= 400 mg/dL or LDL-C \<= 50 mg/dL; where, LDL-C value was measured directly by preparative ultracentrifugation (PUC).

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins]5.98 ± 2.925-31.80 ± 2.054
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 · Least squares (ls) means: -37.78 · 95% CI -44.79 to -30.78
SecondaryPercent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]

LS mean percent change from baseline to Day 365 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC]10.30 ± 4.222-31.14 ± 2.544
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -41.45 · 95% CI -51.14 to -31.76
SecondaryPercent Change in Apolipoprotein B (ApoB) From Baseline to Day 84

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

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 842.93 ± 1.758-21.45 ± 1.219
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -24.39 · 95% CI -28.58 to -20.20
SecondaryPercent Change in Apolipoprotein B (ApoB) From Baseline to Day 180

LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 1806.02 ± 2.127-18.30 ± 1.472
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -24.32 · 95% CI -29.38 to -19.25
SecondaryPercent Change in Apolipoprotein B (ApoB) From Baseline to Day 365

LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 3658.15 ± 2.633-17.62 ± 1.663
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -25.77 · 95% CI -31.88 to -19.67
SecondaryPercent Change in Non-HDL-C From Baseline to Day 84

LS mean percent change from baseline to Day 84 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) in obicetrapib group compared to the placebo group

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Non-HDL-C From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Non-HDL-C From Baseline to Day 842.83 ± 2.188-31.62 ± 1.520
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -34.45 · 95% CI -39.67 to -29.24
SecondaryPercent Change in Non-HDL-C From Baseline to Day 180

LS mean percent change from baseline to Day 180 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Non-HDL-C From Baseline to Day 180
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Non-HDL-C From Baseline to Day 1805.92 ± 2.658-27.08 ± 1.855
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -33.00 · 95% CI -39.36 to -26.65
SecondaryPercent Change in Non-HDL-C From Baseline to Day 365

LS mean percent change from baseline to Day 365 in Non-high-density Lipoprotein Cholesterol (non-HDL-C) in obicetrapib group compared to the placebo group

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Non-HDL-C From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Non-HDL-C From Baseline to Day 36511.64 ± 3.905-25.84 ± 2.305
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05) · Least squares (ls) means: -37.48 · 95% CI -46.38 to -28.58
SecondaryPercent Change in HDL-C From Baseline to Day 84

LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in HDL-C From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in HDL-C From Baseline to Day 841.26 ± 5.078139.92 ± 3.614
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05) · Least squares (ls) means: 138.66 · 95% CI 126.42 to 150.90
SecondaryPercent Change in HDL-C From Baseline to Day 180

LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in HDL-C From Baseline to Day 180
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in HDL-C From Baseline to Day 1802.63 ± 5.484133.83 ± 3.730
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05) · Least squares (ls) means: 131.20 · 95% CI 118.27 to 144.13
SecondaryPercent Change in HDL-C From Baseline to Day 365

LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in HDL-C From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in HDL-C From Baseline to Day 3656.28 ± 5.994127.67 ± 4.222
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value \<0.05) · Least squares (ls) means: 121.39 · 95% CI 107.02 to 135.76
SecondaryPercent Change in Lp(a) From Baseline to Day 84

LS mean percent change from baseline to Day 84 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Lp(a) From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Lp(a) From Baseline to Day 8410.52 ± 9.413-35.42 ± 4.527
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = <.0001 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05) · Least squares (ls) means: -45.94 · 95% CI -65.88 to -26.00
SecondaryPercent Change in Lp(a) From Baseline to Day 365

LS mean percent change from baseline to Day 365 in Lipoprotein (a) \[Lp(a)\] in obicetrapib group compared to the placebo group

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Lp(a) From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Lp(a) From Baseline to Day 36524.37 ± 37.111-29.93 ± 11.224
Statistical analysis
  • Placebo vs Obicetrapib 10 mg · ANCOVA · p = 0.1648 (The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint reached a statistically significant treatment effect at p-value\<0.05; therefore hierarchical testing was stopped for subsequent secondary endpoints) · Least squares (ls) means: -54.30 · 95% CI -131.13 to 22.53
SecondaryPercent Change in Total Cholesterol From Baseline to Day 84

LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Total Cholesterol From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Total Cholesterol From Baseline to Day 842.34 ± 1.79612.09 ± 1.268
SecondaryPercent Change in Total Cholesterol From Baseline to Day 180

LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Total Cholesterol From Baseline to Day 180
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Total Cholesterol From Baseline to Day 1804.44 ± 2.04314.43 ± 1.438
SecondaryPercent Change in Total Cholesterol From Baseline to Day 365

LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group

Time frame:
365 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Total Cholesterol From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Total Cholesterol From Baseline to Day 3659.32 ± 2.80113.92 ± 1.684
SecondaryPercent Change in Triglycerides From Baseline to Day 84

LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group

Time frame:
84 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Triglycerides From Baseline to Day 84
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Triglycerides From Baseline to Day 8410.16 ± 4.207-1.57 ± 2.580
SecondaryPercent Change in Triglycerides From Baseline to Day 180

LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group

Time frame:
180 Days
Reported as:
Least squares mean · percent change from baseline
Percent Change in Triglycerides From Baseline to Day 180
percent change from baselinePlaceboObicetrapib 10 mg
Percent Change in Triglycerides From Baseline to Day 18012.43 ± 4.1784.49 ± 2.885
SecondaryPrecent Change in Triglycerides From Baseline to Day 365

LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group

Time frame:
365 days
Reported as:
Least squares mean · percent change from baseline
Precent Change in Triglycerides From Baseline to Day 365
percent change from baselinePlaceboObicetrapib 10 mg
Precent Change in Triglycerides From Baseline to Day 3657.39 ± 5.6422.27 ± 3.219

Adverse events

Collected over From first dose of study drug up to Week 54. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo2/118 (1.7%)8/118 (6.8%)52/118 (44.1%)
Obicetrapib 10 mg3/234 (1.3%)13/234 (5.6%)95/234 (40.6%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventPlaceboObicetrapib 10 mg
Angina pectorisCardiac disorders2/1180/234
Angina unstableCardiac disorders0/1182/234
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/1182/234
DeathGeneral disorders1/1180/234
EnteritisGastrointestinal disorders1/1180/234
Gastrointestinal fistulaGastrointestinal disorders1/1180/234
Deep vein thrombosisVascular disorders1/1180/234
Diabetic gangreneInfections and infestations1/1180/234
CholecystitisHepatobiliary disorders1/1180/234
Sudden cardiac deathCardiac disorders1/1180/234
Most frequent other events
Showing 10 of 15
Most frequent other events
EventPlaceboObicetrapib 10 mg
InfluenzaInfections and infestations7/11821/234
COVID-19Infections and infestations8/11815/234
DiarrheaGastrointestinal disorders8/1189/234
HypertensionVascular disorders8/11814/234
NasopharyngitisInfections and infestations5/11815/234
FatigueGeneral disorders7/1182/234
Upper respiratory tract infectionInfections and infestations4/11812/234
Back painMusculoskeletal and connective tissue disorders6/1187/234
HeadacheNervous system disorders6/1187/234
MyalgiaMusculoskeletal and connective tissue disorders1/11810/234

Baseline characteristics

Baseline Population is defined as all randomized participants.

Age, Continuous
Age, Continuous(years)PlaceboObicetrapib 10 mgTotal
Mean56.6 ± 11.0657 ± 12.7056.9 ± 12.16
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboObicetrapib 10 mgTotal
Female65125190
Male53111164
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboObicetrapib 10 mgTotal
Hispanic or Latino2810
Not Hispanic or Latino114226340
Unknown or Not Reported224
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboObicetrapib 10 mgTotal
American Indian or Alaska Native000
Asian167
Native Hawaiian or Other Pacific Islander000
Black or African American336
White110219329
More than one race347
Unknown or Not Reported145
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)
Baseline Low-Density Lipoprotein Cholesterol (LDL-C)(mg/dL)PlaceboObicetrapib 10 mgTotal
Mean119.9 ± 54.47123.4 ± 49.23121.65 ± 51.85
08

Study locations

96 sites
  • Site 01022
    Jonesboro, Arkansas 72401, United States
  • Site 01015
    Toluca Lake, California 91602, United States
  • Site 01009
    Sarasota, Florida 34230, United States
  • Site 01023
    Boise, Idaho 83702, United States
  • Site 01018
    Chicago, Illinois 60602, United States
  • Site 01012
    Iowa City, Iowa 52240, United States
  • Site 01007
    Baton Rouge, Louisiana 70809, United States
  • Site 01005
    Port Gibson, Mississippi 39105, United States
  • Site 01006
    Saint Louis, Missouri 63130, United States
  • Site 01011
    Lincoln, Nebraska 68510, United States
  • Site 01004
    Norfolk, Nebraska 68701, United States
  • Site 01002
    Morristown, New Jersey 07960, United States
  • Site 01010
    New Providence, New Jersey 07901, United States
  • Site 01001
    North Massapequa, New York 11758, United States
  • Site 01020
    Morganton, North Carolina 28655, United States
  • Site 01019
    Winston-Salem, North Carolina 27157, United States
  • Site 01008
    Chattanooga, Tennessee 37405, United States
  • Site 01016
    El Paso, Texas 79905, United States
  • Site 01013
    Houston, Texas 76706, United States
  • Site 01014
    Suffolk, Virginia 23434, United States
  • Site 06007
    Brampton, L6Z 4N5, Canada
  • Site 06008
    Chicoutimi, G7H 7K9, Canada
  • Site 06005
    Halifax, B3H 3A7, Canada
  • Site 06009
    Montreal, H3A 1A1, Canada
  • Site 06003
    Montréal, H2W 1R7, Canada
  • Site 06004
    Québec, G1V 4W2, Canada
  • Site 06006
    Sherbrooke, J1H 5N4, Canada
  • Site 06001
    Vancouver, V6Z 2C7, Canada
  • Site 06002
    Victoria, V8T 5G4, Canada
  • Site 02006
    Brno, 65691, Czechia
  • Site 02002
    Hradec Králové, 500 05, Czechia
  • Site 02003
    Praha, 128 08, Czechia
  • Site 02005
    Praha, 140 21, Czechia
  • Site 02004
    Praha, 15006, Czechia
  • Site 02001
    Uherské Hradiště, 686 01, Czechia
  • Site 022001
    Batumi, 6000, Georgia
  • Site 022003
    Tbilisi, 112, Georgia
  • Site 022004
    Tbilisi, 131, Georgia
  • Site 022010
    Tbilisi, 144, Georgia
  • Site 022006
    Tbilisi, 159, Georgia
  • Site 022007
    Tbilisi, 159, Georgia
  • Site 022008
    Tbilisi, 159, Georgia
  • Site 022002
    Tbilisi, 186, Georgia
  • Site 022005
    Tbilisi, 186, Georgia
  • Site 022009
    Tbilisi, 579, Georgia
  • Site 04001
    Amsterdam, 1105AZ, Netherlands
  • Site 04003
    Arnhem, 6815 AD, Netherlands
  • Site 04002
    Deventer, 7416 SE, Netherlands
  • Site 04004
    Eindhoven, 5631 BM, Netherlands
  • Site 04005
    Roosendaal, 4708 AE, Netherlands
  • Site 04006
    Rotterdam, 3015 GD, Netherlands
  • Site 023003
    Bodø, 8008, Norway
  • Site 023002
    Oslo, 587, Norway
  • Site 05002
    Białystok, 15-276, Poland
  • Site 05005
    Zabrze, 41-800, Poland
  • Site 05001
    Zamosc, 22-400, Poland
  • Site 05003
    Łódź, 92-213, Poland
  • Site 05004
    Łódź, 93-338, Poland
  • Site 018001
    Bloemfontein, 9301, South Africa
  • Site 018002
    Cape Town, 7530, South Africa
  • Site 018009
    Centurion, 154, South Africa
  • Site 018006
    Centurion, 157, South Africa
  • Site 018004
    Parow, 7500, South Africa
  • Site 018003
    Somerset West, 7130, South Africa
  • Site 018005
    Somerset West, 7130, South Africa
  • Site 018007
    Tongaat, 4400, South Africa
  • Site 018008
    Umhlanga, 4321, South Africa
  • Site 017001
    Barcelona, 8036, Spain
  • Site 17002
    Barcelona, 8907, Spain
  • Site 17003
    Córdoba, 14004, Spain
  • Site 17018
    Figueras, 17600, Spain
  • Site 17011
    Granada, 18014, Spain
  • Site 17017
    Huelva, 21007, Spain
  • Site 17012
    Huesca, 22002, Spain
  • Site 17004
    La Coruña, 15001, Spain
  • Site 17008
    Las Palmas De Gran Canaria, 35016, Spain
  • Site 17010
    Madrid, 28034, Spain
  • Site 17016
    Madrid, 28041, Spain
  • Site 17007
    Málaga, 29010, Spain
  • Site 17013
    Sabadell, 8208, Spain
  • Site 17015
    Santiago De Compostela, 15706, Spain
  • Site 17009
    Sevilla, 41009, Spain
  • Site 17006
    Sevilla, 41013, Spain
  • Site 17014
    Valencia, 46014, Spain
  • Site 17005
    Zaragoza, 50009, Spain
  • Site 014006
    Birmingham, B21 9RY, United Kingdom
  • Site 014012
    Bristol, BS2 8HW, United Kingdom
  • Site 014009
    Cardiff, CF14 4XW, United Kingdom
  • Site 014010
    Chichester, PO19 6SE, United Kingdom
  • Site 014001
    Dundee, DD1 9SY, United Kingdom
  • Site 014002
    London, NW3 2QG, United Kingdom
  • Site 014003
    Manchester, M23 9LT, United Kingdom
  • Site 014011
    Penzance, TR19 7HU, United Kingdom
  • Site 014005
    Stevenage, SG14AB, United Kingdom
  • Site 014004
    West Bromwich, B71 4HJ, United Kingdom
  • Site 014008
    Wirral, CH62 6EE, United Kingdom
09

References and documents

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 Jul 2022 to primary completion in May 2024, 22 months.

Results were first posted in Jun 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 22 months is close to 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
Jun 15, 2022
First posted
Jun 21, 2022
StartActual
Jul 25, 2022
Primary completionActual
May 28, 2024
CompletionActual
May 28, 2024
Results first posted
Jun 11, 2025
Last update
Jun 11, 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 Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05425745
Lead sponsor
NewAmsterdam Pharma
Responsible party
Sponsor
First posted
Jun 21, 2022
Start date
Jul 25, 2022
Primary completion
May 28, 2024
Completion
May 28, 2024
Results posted
Jun 11, 2025
Last update
Jun 11, 2025

Study contacts

Marc Ditmarsch
study director · NewAmsterdam Pharma

Oversight

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

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This study is completed, as verified in Jun 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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