Trial results for Obicetrapib in patients with dyslipidemia and atherosclerotic cardiovascular disease were posted on ClinicalTrials.gov on 2025-09-19. The Phase 3 study demonstrated that Obicetrapib 10mg significantly reduced low-density lipoprotein cholesterol (LDL-C) by -29.94% from baseline to Day 84, compared to a 2.70% increase in the placebo group.
Background
Dyslipidemias, high cholesterol, hypercholesterolemia, familial hypercholesterolemia, and atherosclerotic cardiovascular disease (ASCVD) are conditions characterized by abnormal levels of lipids in the blood, particularly high LDL-C. These conditions are major risk factors for cardiovascular events. Managing these lipid levels, often as an adjunct to maximally tolerated lipid-lowering therapies, is crucial for reducing cardiovascular risk.
Trial design
This completed Phase 3, placebo-controlled, double-blind, randomized study (NCT05142722) enrolled 2530 participants. The trial evaluated the efficacy, safety, and tolerability of Obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD. The interventions studied were Obicetrapib 10mg and placebo.
Key results
The study measured percent change in Low-Density Lipoprotein Cholesterol (LDL-C) and Apolipoprotein B (ApoB) from baseline at various time points:
- Percent Change in LDL-C From Baseline to Day 84: The Obicetrapib 10mg group showed a least squares mean change of -29.94% (Standard Error: 1.104), while the placebo group showed a change of 2.70% (Standard Error: 1.571). ANCOVA analysis indicated a difference of -32.65% (95% CI: -35.79 to -29.5) with a p-value of 0.0001.
- Percent Change in LDL-C From Baseline to Day 180: The Obicetrapib 10mg group showed a least squares mean change of -29.09% (Standard Error: 1.176), compared to 4.68% (Standard Error: 1.625) in the placebo group. ANCOVA analysis showed a difference of -33.78% (95% CI: -37.07 to -30.49) with a p-value of 0.0001.
- Percent Change in LDL-C From Baseline to Day 365: The Obicetrapib 10mg group showed a least squares mean change of -25.25% (Standard Error: 1.480), compared to -1.27% (Standard Error: 1.798) in the placebo group. ANCOVA analysis showed a difference of -23.98% (95% CI: -27.87 to -20.09) with a p-value of 0.0001.
- Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84: The Obicetrapib 10mg group showed a least squares mean change of -17.84% (Standard Error: 0.669), while the placebo group showed a change of 1.08% (Standard Error: 0.911). ANCOVA analysis indicated a difference of -18.92% (95% CI: -20.76 to -17.09) with a p-value of 0.0001.
- Percent Change in ApoB From Baseline to Day 180: The Obicetrapib 10mg group showed a least squares mean change of -16.07% (Standard Error: 0.742), compared to 2.23% (Standard Error: 1.033) in the placebo group. ANCOVA analysis showed a difference of -18.31% (95% CI: -20.38 to -16.23) with a p-value of 0.0001.
- Percent Change in ApoB From Baseline to Day 365: The Obicetrapib 10mg group showed a least squares mean change of -15.57% (Standard Error: 0.914), compared to -1.77% (Standard Error: 1.165) in the placebo group. ANCOVA analysis showed a difference of -13.8% (95% CI: -16.2 to -11.41) with a p-value of 0.0001.
What this means
The consistent and statistically significant reductions in both LDL-C and ApoB observed with Obicetrapib 10mg across multiple time points (Day 84, Day 180, and Day 365) suggest a robust lipid-lowering effect. These findings indicate that Obicetrapib could be a valuable adjunctive treatment option for patients with dyslipidemias, including those with heterozygous familial hypercholesterolemia and atherosclerotic cardiovascular disease, who require further reduction in their cholesterol levels despite maximally tolerated existing therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05142722, titled "Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies," were posted on 2025-09-19 on clinicaltrials.gov.