Trial · NCT05142722
Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
NCT05142722, Phase 3, Completed, NewAmsterdam Pharma; results first posted 2025-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies. Trials, record NCT05142722. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05142722
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
- NCT number
- NCT05142722
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,530 participants, actual
- Lead sponsor
- NewAmsterdam Pharma
- Conditions
- Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
- Interventions
- Placebo, Obicetrapib
- First posted
- 2021-12-03
- Last updated
- 2025-09-19
- Results first posted
- 2025-09-19
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | 84 Days | 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). |
| Secondary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | 180 Days | 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). |
| Secondary | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | 365 Days | 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). |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group. |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | 180 Days | LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group. |
| Secondary | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | 365 Days | LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group. |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 84 | 84 Days | 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. |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 180 | 180 Days | 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. |
| Secondary | Percent Change in Non-HDL-C From Baseline to Day 365 | 365 Days | 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. |
| Secondary | Percent Change in HDL-C From Baseline to Day 84 | 84 Days | LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | 84 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | 180 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | 365 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | 84 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | 180 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 | 365 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Non-HDL-C From Baseline to Day 84 | 84 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Non-HDL-C From Baseline to Day 180 | 180 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in Non-HDL-C From Baseline to Day 365 | 365 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in HDL-C From Baseline to Day 84 | 84 Days | Baseline Population is defined as all participants who were randomized in the study. Baseline values were defined as last measurement prior to the first dose of study drug. Missing values were imputed using a multiple imputation model assuming the data are missing not at random. Missing measurements of non-retrieved dropouts were modeled by known measurements from retrieved dropouts in the same treatment group. | percent change from baseline | LEAST_SQUARES_MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | Placebo | 2.70 | Standard Error 1.571 | percent change from baseline | |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | Obicetrapib 10mg | -29.94 | Standard Error 1.104 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | Placebo | 4.68 | Standard Error 1.625 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | Obicetrapib 10mg | -29.09 | Standard Error 1.176 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | Placebo | -1.27 | Standard Error 1.798 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | Obicetrapib 10mg | -25.25 | Standard Error 1.480 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | Placebo | 1.08 | Standard Error 0.911 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | Obicetrapib 10mg | -17.84 | Standard Error 0.669 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | Placebo | 2.23 | Standard Error 1.033 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | Obicetrapib 10mg | -16.07 | Standard Error 0.742 | percent change from baseline |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 844 | |
| Overall Study | STARTED | Obicetrapib 10mg | 1,686 | |
| Overall Study | COMPLETED | Placebo | 795 | |
| Overall Study | COMPLETED | Obicetrapib 10mg | 1,600 | |
| Overall Study | NOT COMPLETED | Placebo | 49 | |
| Overall Study | NOT COMPLETED | Obicetrapib 10mg | 86 |
Source ClinicalTrials.gov
Adverse events508
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Placebo | 48 | 843 | 49 |
| other | COVID-19 | Infections and infestations | Obicetrapib 10mg | 81 | 1,685 | 81 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 33 | 843 | 35 |
| other | Upper respiratory tract infection | Infections and infestations | Obicetrapib 10mg | 49 | 1,685 | 54 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 22 | 843 | 26 |
| other | Nasopharyngitis | Infections and infestations | Obicetrapib 10mg | 43 | 1,685 | 55 |
| other | Urinary tract infection | Infections and infestations | Placebo | 21 | 843 | 25 |
| other | Urinary tract infection | Infections and infestations | Obicetrapib 10mg | 39 | 1,685 | 41 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 24 | 843 | 28 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Obicetrapib 10mg | 38 | 1,685 | 40 |
1 to 10 of 508Source ClinicalTrials.gov
See all 508 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 12 | 843 |
| Total, all-cause mortality | Obicetrapib 10mg | 19 | 1,685 |
| Total, other adverse events | Placebo | 241 | 843 |
| Total, other adverse events | Obicetrapib 10mg | 459 | 1,685 |
| Total, serious adverse events | Placebo | 117 | 843 |
| Total, serious adverse events | Obicetrapib 10mg | 211 | 1,685 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Obicetrapib 10mg vs Placebo: deaths from any cause | Trial comparisons |
| Obicetrapib 10mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05142722
GET https://conductscience.org/api/trials/v1/NCT05142722/outcomes?page=2