DyslipidemiaPhase 1NCT04055168

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 in Healthy Subjects

A Phase 1 study testing AZD6615 in people with Dyslipidemia, run by AstraZeneca at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study will be a randomized, single-blind, placebo-controlled, single-ascending dose (SAD), sequential group study. It is a SAD study in healthy Non-Asian subjects (Part 1) and healthy Japanese subjects (Part 2) to assess the safety and tolerability of AZD6615 and to characterize the pharmacokinetics (PK) of… Read more about this study

Who is it for?: Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dyslipidemia
What is being tested?: AZD6615
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 24 Jul 2019to 10 Feb 2020
Phase: Phase 1
Are there results?: None posted in the registry

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 20 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential.
Provision of signed, written and dated informed consent for optional genetic research.
4: In Part 1: Healthy male and/or female Non-Asian subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. In Part 2: Healthy male and/or female Japanese subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
5. Have a body mass index between 18 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at the Screening Visit and Day -1.
6. Males should avoid fathering a child by either true abstinence or a highly effective contraception form of birth control during the study.

Who cannot join

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: (Alanine aminotransferase > upper limit of normal [ULN], Aspartate aminotransferase > ULN, Creatinine > ULN, White blood cell count < 3.5 x 10^9/L, Hb < lower limit of normal [LLN], Platelet count <LLN).
Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus.

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Abnormal vital signs, any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-Lead ECG as considered by the Investigator, that may interfere with the interpretation of QTc interval changes.
Known or suspected history of drug abuse, current smoker or those who have smoked or used nicotine products within the previous 3 months before the Screening Visit.
History of alcohol abuse and/or severe allergy/hypersensitivity.
Previous bone marrow transplant.
Males who are unwilling to use an acceptable method of birth control during the entire study period.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects

Read the detailed description

This study part is planned to consist of 3 cohorts of Non-Asian subjects (Part 1) and 2 cohorts of Japanese subjects (Part 2). Part 2 will be initiated no earlier than after completion of the last Safety Review Committee (SRC) review in Part 1. Healthy male and/or female subjects aged 20 to 60 years will be included in both Parts 1 and 2 of the study. Female subjects must be of non-childbearing potential. Study Part 1 is planned to be conducted in 24 subjects but may be conducted in up to 40 subjects. Study Part 2 is planned to be conducted in 16 subjects but may be conducted in up to 32 subjects.

Within each cohort of Parts 1 and 2, 6 subjects will be randomized to receive AZD6615 and 2 subjects will be randomized to receive placebo. Dosing and food intake should be supervised and documented by study staff when subjects are in the clinic.

The study will comprise of:

A Screening Period of maximum 28 days.
A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4.
A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose.

Within each cohort, site personnel remain blinded until the SRC meeting.

Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts:

The time window between the sentinel dose group and the main dose group in Part 1.
The length of the stay at the study site, the timing and number of assessments and/or samples.
The length of the follow-up period.
The length of the data collection period for the SRC review.

Conditions: Dyslipidemia
Being tested: AZD6615, Placebo
Keywords: Dyslipidemia, Single Ascending Dose, Safety, Tolerability
Medical subject headings: Dyslipidemias

What participants receive

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

AZD6615Drug
Also called Study drug
AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.
PlaceboDrug
Also called Control
Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.

Study groups in NCT04055168
Study group	Role	What they receive
Cohort 1 - Part 1	Experimental	On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD6615; Drug: Placebo
Cohort 2 - Part 1	Experimental	On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD6615; Drug: Placebo
Cohort 3 - Part 1	Experimental	On Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 3 of AZD6615 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD6615; Drug: Placebo
Cohort 1 - Part 2	Experimental	On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD6615; Drug: Placebo
Cohort 2 - Part 2	Experimental	On Day 1, randomized subjects (healthy Japanese subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD6615; Drug: Placebo

What is being measured

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

Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD6615 following the administration of SAD
Measured: From screening to 12 weeks of follow-up

Secondary outcomes (15)

Plasma PK analysis: Maximum observed concentration (Cmax)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Time to reach maximum observed concentration (tmax)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Terminal half-life (t½λz)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plama PK analysis: Terminal elimination rate constant (λz)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Apparent volume of distribution (Vz/F)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Apparent total body clearance (CL/F)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plama PK analysis: Mean Residence Time from time 0 to infinity (MRT)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Observed maximum concentration divided by the dose administered (Cmax/D)
To characterize the PK of AZD6615 after single dosing
Measured: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
PD analysis: Levels of dyslipidemia related biomarkers
This study will also investigate the PD of AZD6615 by investigating the effect of AZD6615 on levels of dyslipidemia related biomarkers
Measured: At screening, on Days -1, Days 1 to 4 (Pre-dose and at 24, 48 and 72 hours post-dose), Weeks 2 to 10 (at 2, 4, 6 and 8 weeks post-dose) and on Week 12 post-dose

Timeline

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

24 Jul 201910 Feb 2020

First posted13 Aug 2019
Study start24 Jul 2019
Primary completion10 Feb 2020
Study completion10 Feb 2020

Why it stopped: It was decided to not run the Japanese cohorts in the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DyslipidemiaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04055168
Sponsor's protocol ID: D7991C00001
Status last verified: Dec 2020
First submitted: 15 Jul 2019
Last updated: 14 Dec 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.
PubMed 38970537

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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Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
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A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
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.
Primary Prevention of Atherosclerotic Cardiovascular Disease

All Dyslipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6615 After Single Dosing to Healthy Subjects
ClinicalTrials.gov ID: NCT04055168
Acronym / sponsor ID: D7991C00001
Conditions: Dyslipidemia
Keywords: Dyslipidemia, Single Ascending Dose, Safety, Tolerability
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: It was decided to not run the Japanese cohorts in the study.
Enrolment: 24 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 24 Jul 2019 (actual)
Primary completion: 10 Feb 2020 (actual)
Study completion: 10 Feb 2020 (actual)
First posted: 13 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

The study will comprise of:

A Screening Period of maximum 28 days.
A Dosing Session during which subjects will be resident at the Clinical Unit from the day before IMP administration (Day -1) until at least 78 hours after Investigational medicinal product (IMP) administration; discharged on Day 4.
A Follow-Up Period of 12 weeks that will consist of 6 Follow-Up Visits, for which the subjects will return to the Clinical Unit at 2, 4, 6, 8, 10, and 12 weeks post-dose.

Within each cohort, site personnel remain blinded until the SRC meeting.

Following review of the data, the SRC may also decide to adjust the following for subsequent cohorts:

The time window between the sentinel dose group and the main dose group in Part 1.
The length of the stay at the study site, the timing and number of assessments and/or samples.
The length of the follow-up period.
The length of the data collection period for the SRC review.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
Cohort 1 - Part 1	Experimental	Drug: AZD6615, Drug: PlaceboOn Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).
Cohort 2 - Part 1	Experimental	Drug: AZD6615, Drug: PlaceboOn Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).
Cohort 3 - Part 1	Experimental	Drug: AZD6615, Drug: PlaceboOn Day 1, randomized subjects (healthy non-Asian subjects) will receive dose 3 of AZD6615 (6 subjects) or matching placebo (2 subjects).
Cohort 1 - Part 2	Experimental	Drug: AZD6615, Drug: PlaceboOn Day 1, randomized subjects (healthy Japanese subjects) will receive dose 1 of AZD6615 (6 subjects) or matching placebo (2 subjects).
Cohort 2 - Part 2	Experimental	Drug: AZD6615, Drug: PlaceboOn Day 1, randomized subjects (healthy Japanese subjects) will receive dose 2 of AZD6615 (6 subjects) or matching placebo (2 subjects).

Who may qualify

Ages: 20 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non-child-bearing potential.
Provision of signed, written and dated informed consent for optional genetic research.
4: In Part 1: Healthy male and/or female Non-Asian subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture. In Part 2: Healthy male and/or female Japanese subjects aged 20 - 60 years (inclusive at Screening Visit) with suitable veins for cannulation or repeated venipuncture.
5. Have a body mass index between 18 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at the Screening Visit and Day -1.

Key exclusion criteria (11 listed)

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
Subjects with known autoimmune disease or on treatment with immune-modulatory drugs.
Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational medicinal product.
Any laboratory values with the following deviations at the Screening Visit and/or Day -1, test may be repeated once for each visit at the discretion of the Investigator if out of range: (Alanine aminotransferase > upper limit of normal [ULN], Aspartate aminotransferase > ULN, Creatinine > ULN, White blood cell count < 3.5 x 10^9/L, Hb < lower limit of normal [LLN], Platelet count <LLN).

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
AZD6615Also: Study drugAZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.	Drug	Cohort 1 - Part 1, Cohort 1 - Part 2, Cohort 2 - Part 1, Cohort 2 - Part 2, Cohort 3 - Part 1
PlaceboAlso: ControlPlacebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.	Drug	Cohort 1 - Part 1, Cohort 1 - Part 2, Cohort 2 - Part 1, Cohort 2 - Part 2, Cohort 3 - Part 1

Primary outcome

Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From screening to 12 weeks of follow-up
To assess the safety and tolerability of AZD6615 following the administration of SAD

15 secondary outcomes

Plasma PK analysis: Maximum observed concentration (Cmax)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Time to reach maximum observed concentration (tmax)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Terminal half-life (t½λz)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plama PK analysis: Terminal elimination rate constant (λz)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC0-24)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Apparent volume of distribution (Vz/F)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Apparent total body clearance (CL/F)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered (AUC0-24/D)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plama PK analysis: Mean Residence Time from time 0 to infinity (MRT)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
Plasma PK analysis: Observed maximum concentration divided by the dose administered (Cmax/D)
Time frame: Days 1 to 4: Pre-dose and then at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose
PD analysis: Levels of dyslipidemia related biomarkers
Time frame: At screening, on Days -1, Days 1 to 4 (Pre-dose and at 24, 48 and 72 hours post-dose), Weeks 2 to 10 (at 2, 4, 6 and 8 weeks post-dose) and on Week 12 post-dose

Results and safety

The study was stopped early (reason given: It was decided to not run the Japanese cohorts in the study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
Derived from this study: PubMed 38970537Makhmudova U, Steinhagen-Thiessen E, Volpe M, Landmesser U. Advances in nucleic acid-targeted therapies for cardiovascular disease prevention. Cardiovasc Res. 2024 Sep 2;120(10):1107-1125. doi: 10.1093/cvr/cvae136.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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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.

David Han, MD principal investigator

California Clinical Trials Medical Group

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD6615 in people with Dyslipidemia, run by AstraZeneca at 2 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was stopped early (reason given: It was decided to not run the Japanese cohorts in the study.). Results are not available in the source record.

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?

Number of subjects with adverse events (AEs) and serious adverse events (SAEs) (time frame: From screening to 12 weeks of follow-up). 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 NCT04055168, which also lists 1 linked publication.

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 14 Dec 2020.