Trial · NCT05425745
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
NCT05425745, Phase 3, Completed, NewAmsterdam Pharma; results first posted 2025-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies. Trials, record NCT05425745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05425745
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
- NCT number
- NCT05425745
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 354 participants, actual
- Lead sponsor
- NewAmsterdam Pharma
- Conditions
Dyslipidemias, High Cholesterol, Hypercholesterolemia, Familial Hypercholesterolemia, Lipid Metabolism Disorder, Metabolic Disease, Lipid Metabolism, Inborn Errors, Genetic Disease, Inborn, Hyperlipoproteinemias
- Interventions
- Obicetrapib, Placebo
- First posted
- 2022-06-21
- Last updated
- 2025-06-11
- Results first posted
- 2025-06-11
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 outcomesOutcomes20
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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 180. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 365. | 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. 2 participants in the obi arm were randomized but did not receive study drug, therefore the n for the obi arm baseline values did not exceed n=234. In addition, participants needed available labs at both baseline and Day 84. | percent change from baseline | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
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 | .25 | Standard Error 2.480 | percent change from baseline | |
| Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] | Obicetrapib 10 mg | -36.05 | Standard Error 1.769 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | Placebo | 5.98 | Standard Error 2.925 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] | Obicetrapib 10 mg | -31.80 | Standard Error 2.054 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | Placebo | 10.30 | Standard Error 4.222 | percent change from baseline | |
| Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] | Obicetrapib 10 mg | -31.14 | Standard Error 2.544 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | Placebo | 2.93 | Standard Error 1.758 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 | Obicetrapib 10 mg | -21.45 | Standard Error 1.219 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | Placebo | 6.02 | Standard Error 2.127 | percent change from baseline | |
| Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 | Obicetrapib 10 mg | -18.30 | Standard Error 1.472 | percent change from baseline |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 | 118 | |
| Overall Study | STARTED | Obicetrapib 10 mg | 236 | |
| Overall Study | COMPLETED | Placebo | 110 | |
| Overall Study | COMPLETED | Obicetrapib 10 mg | 226 | |
| Overall Study | NOT COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Obicetrapib 10 mg | 10 |
Source ClinicalTrials.gov
Adverse events82
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 | Influenza | Infections and infestations | Placebo | 7 | 118 | 7 |
| other | Influenza | Infections and infestations | Obicetrapib 10 mg | 21 | 234 | 22 |
| other | COVID-19 | Infections and infestations | Placebo | 8 | 118 | 8 |
| other | COVID-19 | Infections and infestations | Obicetrapib 10 mg | 15 | 234 | 16 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 118 | 5 |
| other | Nasopharyngitis | Infections and infestations | Obicetrapib 10 mg | 15 | 234 | 17 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 4 | 118 | 4 |
| other | Upper respiratory tract infection | Infections and infestations | Obicetrapib 10 mg | 12 | 234 | 15 |
| other | Urinary tract infection | Infections and infestations | Placebo | 5 | 118 | 5 |
| other | Urinary tract infection | Infections and infestations | Obicetrapib 10 mg | 7 | 234 | 7 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 2 | 118 |
| Total, all-cause mortality | Obicetrapib 10 mg | 3 | 234 |
| Total, other adverse events | Placebo | 52 | 118 |
| Total, other adverse events | Obicetrapib 10 mg | 95 | 234 |
| Total, serious adverse events | Placebo | 8 | 118 |
| Total, serious adverse events | Obicetrapib 10 mg | 13 | 234 |
Source ClinicalTrials.gov
Papers2
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 10 mg vs Placebo: deaths from any cause | Trial comparisons |
| Obicetrapib 10 mg 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/NCT05425745
GET https://conductscience.org/api/trials/v1/NCT05425745/results?page=2