DyslipidemiaPhase 2NCT05421078

A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.

A Phase 2 study testing Obicetrapib in people with Dyslipidemia and Hypercholesterolemia, run by NewAmsterdam Pharma at 10 sites in Japan.

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

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study in Japanese patients to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Dyslipidemia, Hypercholesterolemia, High Cholesterol
What is being tested?: Obicetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: 10 sitesJapan
Study dates: 27 Jun 2022to 21 Apr 2023
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 TG < 400 mg/dL,
Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20

Who cannot join

BMI > or =35 kg/m2
Significant cardiovascular disease
HbA1c > 10%
Uncontrolled hypertension
Active muscle disease
GFR < 60 ml/min

Show all 16Show fewer

Hepatic dysfunction
Anemia
Existing CETP deficiency
History of Homozygous Familial Hypercholerstrolemia
History of malignancy
Alcohol abuse
Treatment with investigational product
Treatment with PCSK9
Clinically significant condition
Known CETP inhibitor allergy

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Japan10 sites

Nippon Kokan Fukuyama Hospital
Fukuyama
Nakamura Cardiology and Cardiovascular Surgery Clinic
Itoshima
Kishiwada Tokushu-Kai Hospital
Osaka
Kyosokai AMC NISHI-UMEDA Clinic
Osaka
Sakurabashi Watanabe Hospital
Osaka
Uji Tokushu-Kai Hospital
Osaka
Sanai Hospital
Saitama
Shinden Higashi Clinic
Sendai
Soka-Sugiura Clinic
Sōka
Sugiura Clinic
Tokyo

Other trials in Japan

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.

Read the detailed description

This study will be a placebo-controlled, double-blind, randomized, phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to stable statin therapy in Japanese patients. The screening period for this study will take up to 2-weeks. Afterwards, patients will be randomized to placebo, 2.5 mg obicetrapib, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period. After the treatment period, patients will continue for a 4-week safety follow-up visit.

Conditions: Dyslipidemia, Hypercholesterolemia, High Cholesterol
Being tested: Obicetrapib, Placebo
Keywords: obicetrapib, statin, LDL-C cholestero, l atherosclerosis
Medical subject headings: Dyslipidemias, Hypercholesterolemia

What participants receive

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

ObicetrapibDrug
Also called CETP inhibitor
tablet
PlaceboDrug
Also called placebo tablet
No active ingredient

Study groups in NCT05421078
Study group	Role	What they receive
Placebo	Placebo comparator	Once-daily placebo Receives: Drug: Placebo
2.5 mg Obicetrapib	Experimental	once-daily Obicetrapib Receives: Drug: Obicetrapib
5 mg Obicetrapib	Experimental	once-daily Obicetrapib Receives: Drug: Obicetrapib
10 mg Obicetrapib	Experimental	once-daily Obicetrapib Receives: Drug: Obicetrapib

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) [Friedewald]
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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: 8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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: 8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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: 8 Weeks
Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Measured: 8 Weeks
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)
Measured: 8 Weeks
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Measured: 8 Weeks

Secondary outcomes (9)

Mean Percent Change in Apolipoprotein B (ApoB)
Mean percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Measured: 8 Weeks
Median Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Measured: 8 Weeks
LS Mean Percent Change in Apolipoprotein B (ApoB)
Median percent change from baseline to Day 56 in apolipoprotein B (ApoB) (mg/dL) for each obicetrapib group compared with the placebo group.
Measured: 8 Weeks
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Measured: 8 weeks
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Median percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Measured: 8 Weeks
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
LS Mean percent change from baseline to Day 56 in non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Measured: 8 Weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Measured: 8 weeks
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Median percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group
Measured: 8 Weeks
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
LS Mean percent change from baseline to Day 56 in High-density lipoprotein cholesterol (HDL-C) (mg/dL) for each obicetrapib group compared with the placebo group.
Measured: 8 Weeks

Timeline

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

27 Jun 202221 Apr 2023

First posted16 Jun 2022
Study start27 Jun 2022
Primary completion24 Mar 2023
Study completion21 Apr 2023

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 DyslipidemiaStudies 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: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05421078
Sponsor's protocol ID: TA-8995-203
Status last verified: Sep 2024
First submitted: 13 Jun 2022
Last updated: 29 Oct 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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Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled, Double-Blind, Randomized, Phase 2 Dose-Finding Study to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy in Japanese Subjects.
ClinicalTrials.gov ID: NCT05421078
Acronym / sponsor ID: TA-8995-203
Conditions: Dyslipidemia, Hypercholesterolemia, High Cholesterol
Keywords: obicetrapib, statin, LDL-C cholestero, l atherosclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: NewAmsterdam PharmaIndustry (pharma, biotech, devices)
Study start: 27 Jun 2022 (actual)
Primary completion: 24 Mar 2023 (actual)
Study completion: 21 Apr 2023 (actual)
First posted: 16 Jun 2022 (actual)
Results: Posted 27 Sep 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: 4
Model description: Placebo-controlled, double-blind, randomized

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboOnce-daily placebo
2.5 mg Obicetrapib	Experimental	Drug: Obicetrapibonce-daily Obicetrapib
5 mg Obicetrapib	Experimental	Drug: Obicetrapibonce-daily Obicetrapib
10 mg Obicetrapib	Experimental	Drug: Obicetrapibonce-daily Obicetrapib

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 TG < 400 mg/dL,
Treated with a stable statin therapy; Atorvastatin 20/40 or Simvastatin 10/20

Key exclusion criteria (16 listed)

BMI > or =35 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 inhibitortablet	Drug	10 mg Obicetrapib, 2.5 mg Obicetrapib, 5 mg Obicetrapib
PlaceboAlso: placebo tabletNo active ingredient	Drug	Placebo

Primary outcome

Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]
Time frame: 8 Weeks
Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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) [Friedewald]
Time frame: 8 Weeks
Median percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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) [Friedewald]
Time frame: 8 Weeks
LS Mean percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to 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) [PUC]
Time frame: 8 Weeks
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Time frame: 8 Weeks
Median Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC)
LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]
Time frame: 8 Weeks
Mean Percent change from Day 1 to Day 56 in Low-Density Lipoprotein Cholesterol (LDL-C) for each obicetrapib group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).

9 secondary outcomes

Mean Percent Change in Apolipoprotein B (ApoB)
Time frame: 8 Weeks
Median Percent Change in Apolipoprotein B (ApoB)
Time frame: 8 Weeks
LS Mean Percent Change in Apolipoprotein B (ApoB)
Time frame: 8 Weeks
Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: 8 weeks
Median Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: 8 Weeks
LS Mean Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
Time frame: 8 Weeks
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: 8 weeks
Median Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: 8 Weeks
LS Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C)
Time frame: 8 Weeks

Results and safety

Results posted to the registry on 27 Sep 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	26	26
Experimental 2.5 mg Obicetrapib	25	25
Experimental 5 mg Obicetrapib	25	25
Experimental 10 mg Obicetrapib	26	26

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Time frame: 8 Weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Placebo n = 26	2.5 mg Obicetrapib n = 25	5 mg Obicetrapib n = 25	10 mg Obicetrapib n = 26
Value	-0.78 (14.581)	-25.90 (21.259)	-33.78 (13.247)	-36.80 (25.727)

Placebo vs 2.5 mg Obicetrapib: Least Squares (LS) Means: -25.84 (95% CI -36.53 to -15.14), p <.0001, Mixed Models Analysis
Placebo vs 5 mg Obicetrapib: Least Squares (LS) Means: -33.34 (95% CI -44.01 to -22.66), p <.0001, Mixed Models Analysis
Placebo vs 10 mg Obicetrapib: Least Squares (LS) Means: -36.12 (95% CI -46.68 to -25.55), p <.0001, Mixed Models Analysis

Population analysed: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Primary outcome: Median Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Time frame: 8 Weeks. Median (Full Range). Unit: percent change from baseline

Measure	Placebo n = 26	2.5 mg Obicetrapib n = 25	5 mg Obicetrapib n = 25	10 mg Obicetrapib n = 26
Value	-0.89 (-38.6 to 27.8)	-24.81 (-66.0 to 17.7)	-31.94 (-56.8 to -2.9)	-45.80 (-73.0 to 45.5)

Placebo vs 2.5 mg Obicetrapib: Least Squares (LS) Means: -25.84 (95% CI -36.53 to -15.14), p <.0001, Mixed Models Analysis
Placebo vs 5 mg Obicetrapib: Least Squares (LS) Means: -33.34 (95% CI -44.01 to -22.66), p <.0001, Mixed Models Analysis
Placebo vs 10 mg Obicetrapib: Least Squares (LS) Means: -36.12 (95% CI -46.68 to -25.55), p <.0001, Mixed Models Analysis

Population analysed: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Primary outcome: LS Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [Friedewald]

Time frame: 8 Weeks. Least squares mean (Standard Error). Unit: percent change from baseline

Measure	Placebo n = 26	2.5 mg Obicetrapib n = 25	5 mg Obicetrapib n = 25	10 mg Obicetrapib n = 26
Value	-0.48 (3.766)	-26.32 (3.844)	-33.82 (3.838)	-36.60 (3.765)

Placebo vs 2.5 mg Obicetrapib: Least Squares (LS) Means: -25.84 (95% CI -36.53 to -15.14), p <.0001, Mixed Models Analysis
Placebo vs 5 mg Obicetrapib: Least Squares (LS) Means: -33.34 (95% CI -44.01 to -22.66), p <.0001, Mixed Models Analysis
Placebo vs 10 mg Obicetrapib: Least Squares (LS) Means: -36.12 (95% CI -46.68 to -25.55), p <.0001, Mixed Models Analysis

Population analysed: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

Primary outcome: Mean Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) [PUC]

Time frame: 8 Weeks. Mean (Standard Deviation). Unit: percent change from baseline

Measure	Placebo n = 26	2.5 mg Obicetrapib n = 25	5 mg Obicetrapib n = 25	10 mg Obicetrapib n = 26
Value	0.43 (15.456)	-26.10 (23.477)	-30.50 (14.959)	-36.29 (24.513)

Placebo vs 2.5 mg Obicetrapib: Least Squares (LS) Means: -27.20 (95% CI -38.37 to -16.04), p <.0001, ANCOVA
Placebo vs 5 mg Obicetrapib: Least Squares (LS) Means: -31.23 (95% CI -42.36 to -20.10), p <.0001, ANCOVA
Placebo vs 10 mg Obicetrapib: Least Squares (LS) Means: -36.81 (95% CI -47.83 to -25.80), p <.0001, ANCOVA

Population analysed: Baseline Population is defined as all participants who received at least one dose of study drug and had a baseline value for LDL-C assessment.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug through Week 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 26 (0%)	15 of 26 (57.7%)	0 of 26
Experimental 2.5 mg Obicetrapib	0 of 25 (0%)	9 of 25 (36%)	0 of 25
Experimental 5 mg Obicetrapib	1 of 25 (4%)	7 of 25 (28%)	0 of 25
Experimental 10 mg Obicetrapib	0 of 26 (0%)	15 of 26 (57.7%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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, MD study director

NewAmsterdam Pharma

10 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 in people with Dyslipidemia and Hypercholesterolemia, run by NewAmsterdam Pharma at 10 sites in Japan.

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 16 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. 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 27 Sep 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) [Friedewald] (time frame: 8 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 NCT05421078.

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 29 Oct 2024.