DyslipidemiasPhase 2ROSE2NCT05266586

Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe as an Adjunct to HIS Therapy

A Phase 2 study testing Obicetrapib and Ezetimibe 10mg in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dyslipidemias, High Cholesterol, Hypercholesterolemia
What is being tested?: Obicetrapib and Ezetimibe 10mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 119 participants
Where: 16 sitesUnited States
Study dates: 9 Mar 2022to 8 Sep 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL,
Treated with a high-intensity statin therapy

Who cannot join

BMI >= 40 kg/m2
Significant cardiovascular disease
HbA1c >= 10%
Uncontrolled hypertension
Active muscle disease
estimated glomerular filtration rate < 60 mL/min

Show all 15Show fewer

Hepatic dysfunction
History of participation in any clinical trial evaluating obicetrapib
Anemia
History of malignancy
Alcohol abuse
Treatment with investigational product
Treatment with PCSK9
Clinically significant condition
Known CETP inhibitor allergy

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Biofortis, Inc
Addison, Illinois, 60101
Northwest Heart Clinical Research, LLC
Arlington Heights, Illinois, 60005
Mercury Street Medical
Butte, Montana, 59701
Meridian Clinical Research- Springdale, OH
Cincinnati, Ohio, 45219
Aventiv Research, Inc.
Columbus, Ohio, 43213
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Velocity Clinical Research - Westlake d.b.a National Research Institute
Los Angeles, California, 90057
Velocity Clinical Research
Meridian, Idaho, 83642
Summit Research Group, LLC
Munroe Falls, Ohio, 44240
Valley Clinical Trials, Inc.
Northridge, California, 91325
Ocala Cardiovascular Research
Ocala, Florida, 34471
Research Integrity LLC
Owensboro, Kentucky, 42303
A & R Research Group, LLC
Pembroke Pines, Florida, 33024
Progressive Medical Research
Port Orange, Florida, 32127
Meridian Clinical Research - Savannah, GA
Savannah, Georgia, 31406
Oakland Medical Research Center
Troy, Michigan, 48085

Other trials in United States

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study

Read the detailed description

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. The screening period for this study will take up to 2-weeks. Afterwards patients will be randomized to placebo, 10 mg obicetrapib monotherapy, or 10 mg obicetrapib + 10 mg ezetimibe combination therapy for a 12-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up.

Conditions: Dyslipidemias, High Cholesterol, Hypercholesterolemia
Being tested: Obicetrapib, Ezetimibe 10mg, Obicetrapib placebo, Ezetimibe placebo
Keywords: obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Medical subject headings: Dyslipidemias, Hypercholesterolemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ObicetrapibDrug
Also called CETP inhibitor
tablets
Ezetimibe 10mgDrug
capsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.
Obicetrapib placeboOther
tablets; no active ingredient
Ezetimibe placeboOther
capsules; no active ingredient

Study groups in NCT05266586
Study group	Role	What they receive
Placebo	Placebo comparator	once-daily placebo tablet and placebo capsule Receives: Other: Obicetrapib placebo; Other: Ezetimibe placebo
monotherapy	Experimental	once-daily obicetrapib 10 mg tablet and placebo capsule Receives: Drug: Obicetrapib; Other: Ezetimibe placebo
combination therapy	Experimental	once-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule Receives: Drug: Obicetrapib; Drug: Ezetimibe 10mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
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).
Measured: 12-weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
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).
Measured: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
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).
Measured: 12-Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
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).
Measured: 12-Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
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).
Measured: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
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).
Measured: 12-Weeks

Secondary outcomes (12)

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
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).
Measured: 12-weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
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).
Measured: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
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).
Measured: 12-Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
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).
Measured: 12-Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
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).
Measured: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
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).
Measured: 12-Weeks
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group
Measured: 12-weeks
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group
Measured: 12-Weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg plus ezetimibe 10 mg combination treatment group compared with the placebo group
Measured: 12-Weeks
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: 12-weeks
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
Median percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: 12-Weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
LS Mean percent change from day 1 to day 84 in Apolipoprotein-B (ApoB) for the obicetrapib 10 mg monotherapy treatment group compared with the placebo group
Measured: 12-Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20228 Sep 2022

First posted4 Mar 2022
Study start9 Mar 2022
Primary completion12 Aug 2022
Study completion8 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DyslipidemiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo-controlled, double-blind, randomized
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05266586
Sponsor's protocol ID: TA-8995-202
Acronym: ROSE2
Status last verified: Oct 2022
First submitted: 23 Feb 2022
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruiting
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All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Study to Evaluate the Effect of Obicetrapib 10 mg Daily in Combination With Ezetimibe 10 mg Daily as an Adjunct to High-Intensity Statin Therapy: The ROSE 2 Study
ClinicalTrials.gov ID: NCT05266586
Acronym / sponsor ID: ROSE2 / TA-8995-202
Conditions: Dyslipidemias, High Cholesterol, Hypercholesterolemia
Keywords: obicetrapib, statin, LDL-C, cholesterol, atherosclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: NewAmsterdam PharmaIndustry (pharma, biotech, devices)
Study start: 9 Mar 2022 (actual)
Primary completion: 12 Aug 2022 (actual)
Study completion: 8 Sep 2022 (actual)
First posted: 4 Mar 2022 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: Placebo-controlled, double-blind, randomized

Arm	Type	Receives
Placebo	Placebo comparator	Other: Obicetrapib placebo, Other: Ezetimibe placeboonce-daily placebo tablet and placebo capsule
monotherapy	Experimental	Drug: Obicetrapib, Other: Ezetimibe placeboonce-daily obicetrapib 10 mg tablet and placebo capsule
combination therapy	Experimental	Drug: Obicetrapib, Drug: Ezetimibe 10mgonce-daily obicetrapib 10 mg tablet and ezetimibe 10 mg capsule

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

LDL-C > 70 mg/dL and Triglycerides < 400 mg/dL,
Treated with a high-intensity statin therapy

Key exclusion criteria (15 listed)

BMI >= 40 kg/m2
Significant cardiovascular disease
HbA1c >= 10%
Uncontrolled hypertension
Active muscle disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ObicetrapibAlso: CETP inhibitortablets	Drug	combination therapy, monotherapy
Ezetimibe 10mgcapsules; 10 mg ezetimibe tablets filled into capsule shells, 1 tablet per capsule.	Drug	combination therapy
Obicetrapib placebotablets; no active ingredient	Other	Placebo
Ezetimibe placebocapsules; no active ingredient	Other	Placebo, monotherapy

Primary outcome

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time frame: 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).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time frame: 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).
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]
Time frame: 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).
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time frame: 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).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time frame: 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).
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]
Time frame: 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).

12 secondary outcomes

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
Time frame: 12-weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
Time frame: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [Friedewald]
Time frame: 12-Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
Time frame: 12-Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
Time frame: 12-Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Obicetrapib 10 mg Monotherapy Compared With Placebo [PUC]
Time frame: 12-Weeks
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 12-weeks
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 12-Weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib in Combination With Ezetimibe Compared to Placebo
Time frame: 12-Weeks
Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
Time frame: 12-weeks
Median Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
Time frame: 12-Weeks
LS Mean Percent Change in Apolipoprotein-B (ApoB) for Obicetrapib 10 mg Monotherapy Compared With Placebo
Time frame: 12-Weeks

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	36
Monotherapy	39	36
Combination Therapy	40	38

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

Time frame: 12-weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Placebo n = 36	Combination Therapy n = 31
Value	-0.83 (24.514)	-59.07 (14.814)

Placebo vs Combination Therapy: Least Squares (LS) Means: -58.38 (95% CI -68.59 to -48.18), p <.0001, Mixed Models Analysis

Population analysed: On-treatment defined as all randomized participants who received at least 1 dose of any study drug and had a baseline value for low-density lipoprotein cholesterol (LDL-C), excluding those with PK evidence suggesting participant misconduct, i.e., plasma obicetrapib \< 100 ng/mL

Primary outcome: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

Time frame: 12-Weeks. Median (Full Range). Unit: percent change from baseline

Measure	Placebo n = 36	Combination Therapy n = 31
Value	-6.35 (-36.4 to 96.7)	-63.40 (-83.7 to -29.7)

Placebo vs Combination Therapy: Least Squares (LS) Means: -58.38 (95% CI -68.59 to -48.18), p <.0001, Mixed Models Analysis

Primary outcome: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald]

Time frame: 12-Weeks. Least squares mean (Standard Error). Unit: percent change from baseline

Measure	Placebo n = 40	Combination Therapy n = 31
Value	-0.85 (3.472)	-59.23 (3.786)

Placebo vs Combination Therapy: Least Squares (LS) Means: -58.38 (95% CI -68.59 to -48.18), p <.0001, Mixed Models Analysis

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [PUC]

Time frame: 12-Weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Placebo n = 36	Combination Therapy n = 31
Value	-1.49 (23.762)	-59.51 (15.192)

Placebo vs Combination Therapy: Least Squares (LS) Means: -58.15 (95% CI -68.47 to -47.83), p <.0001, ANCOVA

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through Week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 40 (2.5%)	16 of 40 (40%)	0 of 40
Monotherapy	1 of 39 (2.6%)	8 of 39 (20.5%)	0 of 39
Combination Therapy	0 of 40 (0%)	11 of 40 (27.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marc Ditmarsch study director

NewAmsterdam Pharma

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Obicetrapib and Ezetimibe 10mg in people with Dyslipidemias and High Cholesterol, run by NewAmsterdam Pharma at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) for Combination Treatment Group Compared With the Placebo Group [Friedewald] (time frame: 12-weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.