Phase 3
N=354
Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.
Dyslipidemias · High Cholesterol · Hypercholesterolemia · Familial Hypercholesterolemia · Lipid Metabolism Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05425745 ↗Enrolled (actual)
354
Serious AEs
6.0%
Results posted
Jun 2025
Primary outcome: Primary: Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] — .25; -36.05 percent change from baseline — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Obicetrapib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NewAmsterdam Pharma
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC] |
.25; -36.05 | <.0001 sig |
| SECONDARY Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins] |
5.98; -31.80 | <.0001 sig |
| SECONDARY Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC] |
10.30; -31.14 | <.0001 sig |
| SECONDARY Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84 |
2.93; -21.45 | <.0001 sig |
| SECONDARY Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180 |
6.02; -18.30 | <.0001 sig |
| SECONDARY Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365 |
8.15; -17.62 | <.0001 sig |
| SECONDARY Percent Change in Non-HDL-C From Baseline to Day 84 |
2.83; -31.62 | <.0001 sig |
| SECONDARY Percent Change in Non-HDL-C From Baseline to Day 180 |
5.92; -27.08 | <.0001 sig |
| SECONDARY Percent Change in Non-HDL-C From Baseline to Day 365 |
11.64; -25.84 | <.0001 sig |
| SECONDARY Percent Change in HDL-C From Baseline to Day 84 |
1.26; 139.92 | <.0001 sig |
| SECONDARY Percent Change in HDL-C From Baseline to Day 180 |
2.63; 133.83 | <.0001 sig |
| SECONDARY Percent Change in HDL-C From Baseline to Day 365 |
6.28; 127.67 | <.0001 sig |
| SECONDARY Percent Change in Lp(a) From Baseline to Day 84 |
10.52; -35.42 | <.0001 sig |
| SECONDARY Percent Change in Lp(a) From Baseline to Day 365 |
24.37; -29.93 | 0.1648 |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Day 84 |
2.34; 12.09 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Day 180 |
4.44; 14.43 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Day 365 |
9.32; 13.92 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Day 84 |
10.16; -1.57 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Day 180 |
12.43; 4.49 | — |
| SECONDARY Precent Change in Triglycerides From Baseline to Day 365 |
7.39; 2.27 | — |
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 3 study to Evaluate the Efficacy, Safety, and Tolerability of Obicetrapib in Participants with a History of Heterozygous Familial Hypercholesterolemia (HeFH).
Eligibility Criteria
Inclusion Criteria
- Have a history of heterozygous familial hypercholesterolemia (HeFH) by 1) Genotyping (not a screening assessment), WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of > 8 points; and/or Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH)
- Maximally tolerated lipid Modifying therapy for at least 8 weeks prior to screening such as: ATV (40 or 80), or (ROS 20 or 40 mg), Ezetimide, Bempedoic Acid, PCSK9 targeted therapy for at least 4 doses
- Fasting serum LDL-C ≥70 mg/dL (≥1.80 mmol/L)
Exclusion Criteria
- New York Heart Association class II or IV heart failure or last known left ventricular ejection fraction < 30%;
- Hospitalized for heart failure within 5 years prior to Screening
- Major adverse cardiac event (MACE) within 3 months prior to Screening;
- HbA1c ≥10%, or fasting glucose
- Formal diagnosis of homozygous familial hypercholesterolemia (HoFH)
- Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization
Data sourced from ClinicalTrials.gov (NCT05425745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.