> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/randomized-study-to-evaluate-the-effect-of-obicetrapib-on-e30d21a7-ab58-4b01-8ef1-765f56a20a18
> Record changed: 2026-10-13

# Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Participants

2,530

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Lead sponsor

NewAmsterdam Pharma

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Start date

2021-12-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

Number of sites

181

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Title and summary

**Summary**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Acronym**

BROADWAY

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Short title**

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Official title**

A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Registry reports results**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Dates

**Completion date**

2024-09-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**First posted**

2021-12-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Registry last updated**

2025-09-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Primary completion date**

2024-09-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Start date**

2021-12-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Size and sites

**Actual participants**

2,530

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Participants**

2,530

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Protocol amendments**

8

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Number of sites**

181

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Lead sponsor**

NewAmsterdam Pharma

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Identifiers

**Registry ID**

NCT05142722

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**ClinicalTrials.gov ID**

NCT05142722

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Quadruple masking

**Masking description**

placebo tablet made to resemble active

**Masked roles**

Participants, Care providers, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Outcomes

### Primary outcomes

1. Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 \[PUC\]  
Timeframe: 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 outcomes

1. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 \[Martin/Hopkins\]  
Timeframe: 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).
2. Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 \[PUC\]  
Timeframe: 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).
3. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84  
Timeframe: 84 Days  
LS mean percent change from baseline to Day 84 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
4. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180  
Timeframe: 180 Days  
LS mean percent change from baseline to Day 180 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
5. Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365  
Timeframe: 365 Days  
LS mean percent change from baseline to Day 365 in apolipoprotein B (ApoB) in obicetrapib group compared to the placebo group.
6. Percent Change in Non-HDL-C From Baseline to Day 84  
Timeframe: 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.
7. Percent Change in Non-HDL-C From Baseline to Day 180  
Timeframe: 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.
8. Percent Change in Non-HDL-C From Baseline to Day 365  
Timeframe: 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.
9. Percent Change in HDL-C From Baseline to Day 84  
Timeframe: 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.
10. Percent Change in HDL-C From Baseline to Day 180  
Timeframe: 180 Days  
LS mean percent change from baseline to Day 180 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
11. Percent Change in HDL-C From Baseline to Day 365  
Timeframe: 365 Days  
LS mean percent change from baseline to Day 365 in High-density Lipoprotein Cholesterol (HDL-C) in obicetrapib group compared to the placebo group.
12. Percent Change in Lp(a) From Baseline to Day 84  
Timeframe: 84 Days  
LS mean percent change from baseline to Day 84 in Lipoprotein (a) \\\[Lp(a)\\\] in obicetrapib group compared to the placebo group.
13. Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84  
Timeframe: 84 Days  
LS mean percent change from baseline to Day 84 in Apolipoprotein A1 (ApoA1) in obicetrapib group compared to the placebo group.
14. Percent Change in Total Cholesterol From Baseline to Day 84  
Timeframe: 84 Days  
LS mean percent change from baseline to Day 84 in Total Cholesterol (TC) in obicetrapib group compared to the placebo group.
15. Percent Change in Total Cholesterol From Baseline to Day 180  
Timeframe: 180 Days  
LS mean percent change from baseline to Day 180 in Total Cholesterol in obicetrapib group compared to the placebo group.
16. Percent Change in Total Cholesterol From Baseline to Day 365  
Timeframe: 365 Days  
LS mean percent change from baseline to Day 365 in Total Cholesterol in obicetrapib group compared to the placebo group.
17. Percent Change in Triglycerides From Baseline to Day 84  
Timeframe: 84 Days  
LS mean percent change from baseline to Day 84 in Triglycerides in obicetrapib group compared to the placebo group.
18. Percent Change in Triglycerides From Baseline to Day 180  
Timeframe: 180 Days  
LS mean percent change from baseline to Day 180 in Triglycerides in obicetrapib group compared to the placebo group.
19. Percent Change in Triglycerides From Baseline to Day 365  
Timeframe: 365 days  
LS mean percent change from baseline to Day 365 in Triglycerides in obicetrapib group compared to the placebo group.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

- Females may be enrolled if all 3 of the following criteria are met:
- They are not pregnant;
- They are not breastfeeding; and
- They do not plan on becoming pregnant during the study;
- Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
- Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows:
- A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening
- Atorvastatin 40 and 80 mg; and
- Rosuvastatin 20 and 40 mg;
- Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening
- Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening
- A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening
- Have a fasting serum LDL-C at Screening as follows:
- Fasting serum LDL-C ≥ 55 to < 100 mg/dL (≥1.4 to <2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to < 130 mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers at Screening;
- Recent MI (> 3 and < 12 months prior to Randomization);
- Type 2 diabetes mellitus;
- Current daily cigarette smoking;
- Age of > 60 years;
- High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening
- Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
- Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
- Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR
- Fasting serum LDL-C ≥ 100 mg/dL (≥2.6 mmol/L) or non-HDL-C ≥130 mg/dL (≥3.4 mmol/L)
- Fasting triglyceride (TG) < 500 mg/dL (<5.7 mmol/L) at Screening; and
- Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening

### Exclusion criteria

- New York Heart Association class III or IV heart failure or 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;
- Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization;
- Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
- Active liver disease;
- HbA1c ≥10% or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening;
- Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening;
- Creatine kinase > 3 X upper limit of normal (ULN) at Screening;
- History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization;
- Known history of alcohol and/or drug abuse within 5 years prior to Randomization
- Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer;
- Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
- Planned use of other investigational products or devices during the course of the study;
- Participated in any clinical trial evaluating obicetrapib; or
- Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
- Any condition that, according to the Investigator, could interfere with the conduct of the study

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Sites

- Pinnacle Research GroupAnniston, United States
- Central Alabama ResearchBirmingham, United States
- Synexus Clinical Research US, Inc. / Simon Williamson Clinic, PCBirmingham, United States
- The Center for Clinical Trials, IncSaraland, United States
- Syed Research Consultants, LLCSheffield, United States
- Clinical Research Institute of Arizona, LLCSun City West, United States
- Synexus Clinical Research US, Inc. / Orange Grove Family PracticeTucson, United States
- Eclipse Clinical ResearchTucson, United States
- American Institute of ResearchBeverly Hills, United States
- Orange County Research CenterTustin, United States
- Synexus Clinical Research US, Inc.Vista, United States
- Excel Medical Clinical TrialsBoca Raton, United States
- Pioneer Clinical StudiesFt. Pierce, United States
- New Generation of Medical ResearchHialeah, United States
- East Coast Institute for Research, LLCJacksonville, United States
- East Coast Institute for Research, LLC - Jacksonville University BlvdJacksonville, United States
- East Coast Institute for Research- Lake CityLake City, United States
- ClinCloud LLCMaitland, United States
- Columbus Clinical Services, LLCMiami, United States
- Kendall South Medical Center, Inc.Miami, United States
- Advanced Research Institute IncNew Port Richey, United States
- Progressive Medical ResearchPort Orange, United States
- East Coast Institute for ResearchSaint Augustine, United States
- Synexus Clinical Research US, Inc.The Villages, United States
- Synexus Clinical Research US, Inc.Atlanta, United States

And 156 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## References

- PubMed 38705341  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38705341/)
Background
- PubMed 40337982  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40337982/)
Results
- PubMed 41109840  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41109840/)
Related publication

- Related resource (pubmed.ncbi.nlm.nih.gov)  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38705341/)
- Related resource (pubmed.ncbi.nlm.nih.gov)  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40337982/)

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05142722)

## Related records

### Drugs (1)

- [Obicetrapib](https://trialight.com/data/asset/obicetrapib-41ee1f14-bdc7-46e1-adcb-5f53d79c7b97.md)

### Lead sponsors (1)

- [NewAmsterdam Pharma](https://trialight.com/data/company/newamsterdam-pharma-e37974fb-1dd3-4985-9cec-1434bedd1a4b.md)

### Conditions (4)

- [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md)
- [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md)
- [Familial hypercholesterolemia](https://trialight.com/data/condition/familial-hypercholesterolemia-ee6bd6b4-71cd-509a-9360-eb8a7c2bd428.md)
- [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md)

### Targets (1)

- [CETP](https://trialight.com/data/target/cetp-ee67b070-5298-5ba4-a1fa-ad945dfd4897.md)

---

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