Adults 18 to 75, any sex, with Dyslipidemias or High Cholesterol. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]Primary· 12-weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG
≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-0.83
± 24.514
Combination Therapy
-59.07
± 14.814
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]Primary· 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG
≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-6.35
-36.4 – 96.7
Combination Therapy
-63.40
-83.7 – -29.7
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]Primary· 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG
≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-0.85
± 3.472
Combination Therapy
-59.23
± 3.786
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]Primary· 12-Weeks
Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-1.49
± 23.762
Combination Therapy
-59.51
± 15.192
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]Primary· 12-Weeks
Median percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-3.95
-34.3 – 91.8
Combination Therapy
-62.80
-82.3 – -31.0
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]Primary· 12-Weeks
LS Mean percent change from Day 1 to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) for the obicetrapib 10 mg + ezetimibe 10 mg combination treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-1.54
± 3.533
Combination Therapy
-59.69
± 3.811
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]Secondary· 12-weeks
Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-0.83
± 24.514
Monotherapy
-39.35
± 22.602
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]Secondary· 12-Weeks
Median percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG ≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-6.35
-36.4 – 96.7
Monotherapy
-43.50
-78.4 – 22.6
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]Secondary· 12-Weeks
LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C was calculated using the Friedewald equation unless TG
≥400 mg/dL or LDL-C ≤50 mg/dL; if TG ≥400 mg/dL or LDL-C ≤50 mg/dL, then LDL-C level was measured directly by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-0.85
± 3.472
Monotherapy
-39.20
± 4.133
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]Secondary· 12-Weeks
Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-1.49
± 23.762
Monotherapy
-39.04
± 23.456
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]Secondary· 12-Weeks
Median percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-3.95
-34.3 – 91.8
Monotherapy
-43.55
-78.4 – 20.4
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]Secondary· 12-Weeks
LS Mean percent change in Low-Density Lipoprotein Cholesterol (LDL-C) from day 1 to day 84 for obicetrapib 10 mg monotherapy treatment group compared with the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Group
Value
95% CI
Placebo
-1.54
± 3.533
Monotherapy
-38.75
± 4.166
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through Week 16.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will be a placebo-controlled, double-blind, randomized, phase 2 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both in combination with ezetimibe 10 mg and as monotherapy, as an adjunct to high-intensity statin therapy.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06250205 — Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
· Phase 1
· completed
NCT05972278 — Investigating the Effect of Obicetrapib on Lipoprotein Metabolism
· Phase 1
· active not recruiting
NCT06048302 — PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
· Phase 1
· completed
NCT06081166 — A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
· Phase 1
· completed
NCT05425745 — Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
· Phase 3
· completed
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Other NewAmsterdam Pharma trials
Trials by the same sponsor.
NCT06547359 — A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
· Phase 1
· completed
NCT06005597 — Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
· Phase 3
· completed
NCT06250205 — Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
· Phase 1
· completed
NCT06050291 — Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
· Phase 1
· completed
NCT05972278 — Investigating the Effect of Obicetrapib on Lipoprotein Metabolism
· Phase 1
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NewAmsterdam Pharma
Last refreshed: 3 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05266586.