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Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies
Phase 3 trial testing Placebo in Dyslipidemias in 2,530 participants. Completed in 26 September 2024.
| Lead sponsor | NewAmsterdam Pharma |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 2,530 |
| Start date | 15 December 2021 |
| Primary completion | 26 September 2024 |
| Estimated completion | 26 September 2024 |
| Sites | 181 locations across Georgia, Denmark, Japan, Netherlands, Poland, China, United States, Czechia |
NewAmsterdam Pharma — full company profile →
18 and older, any sex, with Dyslipidemias or High Cholesterol. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2.70 | ± 1.571 |
| Obicetrapib 10mg | -29.94 | ± 1.104 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 4.68 | ± 1.625 |
| Obicetrapib 10mg | -29.09 | ± 1.176 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.27 | ± 1.798 |
| Obicetrapib 10mg | -25.25 | ± 1.480 |
LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.08 | ± 0.911 |
| Obicetrapib 10mg | -17.84 | ± 0.669 |
LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2.23 | ± 1.033 |
| Obicetrapib 10mg | -16.07 | ± 0.742 |
LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -1.77 | ± 1.165 |
| Obicetrapib 10mg | -15.57 | ± 0.914 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 2.81 | ± 1.212 |
| Obicetrapib 10mg | -26.64 | ± 0.892 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.68 | ± 1.302 |
| Obicetrapib 10mg | -24.63 | ± 0.972 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.63 | ± 1.480 |
| Obicetrapib 10mg | -22.38 | ± 1.186 |
LS mean percent change from baseline to Day 84 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.61 | ± 1.391 |
| Obicetrapib 10mg | 136.87 | ± 1.857 |
LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1.18 | ± 1.897 |
| Obicetrapib 10mg | 135.61 | ± 2.192 |
LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 3.36 | ± 1.651 |
| Obicetrapib 10mg | 125.40 | ± 2.193 |
Time frame: From first dose of study drug up to Week 54. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Obicetrapib 10mg |
|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | — | — |
| Angina unstable | Cardiac disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Cerebral infarction | Nervous system disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Cardiac failure | Cardiac disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Acute left ventricular failure | Cardiac disorders | — | — |
| Arteriosclerosis coronary artery | Cardiac disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Cellulitis | Infections and infestations | — | — |
| Ischaemic stroke | Nervous system disorders | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Atrial flutter | Cardiac disorders | — | — |
| Cardiac failure chronic | Cardiac disorders | — | — |
| Coronary artery stenosis | Cardiac disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Reaction | System | Placebo | Obicetrapib 10mg |
|---|---|---|---|
| Hypertension | Vascular disorders | — | — |
| COVID-19 | Infections and infestations | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Headache | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Acute myocardial infarction, Angina unstable, Pneumonia, Coronary artery disease, Myocardial infarction, Angina pectoris, Cerebral infarction, Cerebrovascular accident.
Data from ClinicalTrials.gov NCT05142722 adverse events section.
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy
8 peer-reviewed publications reference this trial (live from Europe PMC):
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