CardiovascularPhase 1NCT06238466
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 in Participants With Dyslipidemia
A Phase 1 study testing AZD1705 in people with Cardiovascular, run by AstraZeneca at 5 sites in United States.
Trial summary
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular
- What is being tested?
- AZD1705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jan 2024to 8 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female of non-childbearing potential participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test.
- Participants with elevated lipids.
- BMI between 18 and 35 kg/m^2.
- Part B1 - May or may not be receiving moderate- or high-intensity statin therapy.
- Part B3
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- May or may not be receiving moderate- or high-intensity statin therapy.
- Diagnosed with T2D with hemoglobin A1c (HbA1c) < 8% level.
- Parts B1 and B3
- Participants on medications should be on stable medication for ≥ 3 months before Screening with no planned medication or dose change during study participation.
- Parts A2 and B2:
- Participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese.
- Part A3:
- Participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant'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.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator:
- Alanine aminotransferase > 1.5 × upper limit of normal (ULN).
- Aspartate aminotransferase > 1.5 × ULN.
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- Total bilirubin > ULN (Gilbert's syndrome).
- Estimated glomerular filtration rate < 60 milliliter (mL)/minute/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2021 (National Kidney Foundation).
- Hemoglobin < lower limit normal (LLN).
- Any clinically important abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or first admission to the study unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator.
- Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab), or Human immunodeficiency virus (HIV).
- Abnormal vital signs, after 5 minutes supine rest, at Screening and/or first admission to the study unit, defined as any of the following:
- Systolic blood pressure (BP) ≤ 90 millimeters of mercury (mmHg) or > 140 mmHg (Part A) or > 150 mmHg (Part B).
- Diastolic BP < 50 mmHg or > 90 mmHg.
- Heart rate < 45 or > 90 beats per minute (bpm). Note: Blood pressure will be measured in triplicates and the mean value will be used. Where the values are outside the required range at admission, then based on medical history, one retest may be performed at this visit.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG, at Screening and/or first admission to the study unit, as judged by the Investigator, that may interfere with the interpretation of QT interval corrected for heart rate (QTc) interval changes, including abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead or left ventricular hypertrophy.
- Prolonged ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate using Fridericia's correction (QTcF) > 450 ms.
- Family history of long QT syndrome.
- Time from the onset of the P wave to the start of the QRS complex (PR) (PQ) interval shortening < 120 milliseconds (ms) (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
- PR (PQ) interval prolongation (> 220 ms), persistent or intermittent second-degree atrioventricular (AV) block (participants with Wenckebach block while asleep are acceptable), third-degree AV block, or AV dissociation.
- Persistent or intermittent complete Bundle branch block (BBB), Intermittent bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with ECG interval measured from the onset of the QRS complex to the J point (QRS) > 110 ms.
- Participants with QRS > 110 ms but < 115 ms (Part A) or < 120 ms (Part B) are acceptable if there is no evidence of ventricular hypertrophy or pre-excitation.
- Smokers who smoke > 10 cigarettes/day and are unable to comply with the nicotine restriction during the study.
- Known or suspected history of alcohol or drug abuse or those who consume > 3 units of alcohol per day for males or > 2 units of alcohol per day for females (where 1 unit being equal to approximately half pint [284 mL] of beer, one small glass [125 mL] of wine, or one measure [25 mL] of spirits) as judged by the Investigator.
- Positive screen for drugs of abuse or alcohol at Screening or on each admission to the Clinical Unit.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to study compound.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) defined as the regular consumption of more than 500 mg of caffeine per day (one cup ~100 mg caffeine; one cup of tea ~30 mg caffeine) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of investigational medicinal product (IMP). The period of exclusion begins after the final dose.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the Clinical Unit).
- Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Participants who are vegans or have medical dietary restrictions.
- Participants who cannot communicate reliably with the Investigator.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to Screening or on admission as per site standard practice.
- Low-density lipoprotein (LDL) or plasma apheresis within 12 months prior to randomization.
- Part A Only:
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose), and minerals during the 2 weeks prior to the first administration of study intervention or longer if the medication has a long half-life.
- On statin therapy.
- Urine albumin: creatinine ratio > 30 mg/g.
- Part B Only:
- Use of any herbal remedies, mega dose vitamins, and minerals during the two weeks prior to the first administration of study intervention or 5 half-lives, whichever is longer.
- Urine albumin: creatinine ratio > 100 mg/g.
- Parts B1 and B3 Only:
- Contraindication to Magnetic Resonance Imaging (MRI) such as: participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field; participants with a history of extreme claustrophobia; or participants who cannot fit inside the MRI scanner cavity.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206
Research Site
Jacksonville, Florida, 32216
Research Site
San Antonio, Texas, 78229
Research Site
Winter Park, Florida, 32789
About this study
Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 Following Single and Multiple Ascending Doses in Participants With Dyslipidemia
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
Read the detailed description
This is a first time in human study in male and female (of non-childbearing potential) participants with dyslipidemia. The study consists of two parts:
- Part A (single ascending dose): Part A of the study will include three parts: A1 for non-Asian participants, A2 for Japanese participants, and A3 for Chinese participants. Parts A2 and A3 are optional.
- Part B (multiple ascending dose): Part B of the study will include three parts: B1 for non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c < 8%. Parts B2 and B3 are optional.
The study will comprise of:
- A Screening Period of maximum 60 days for both Part A and Part B.
- Part A: A single dose of AZD1705 with an in-clinic period of 3 days.
- An outpatient Follow-up Period of approximately 16 weeks.
- Part B: 2 doses of AZD1705, given 28 days apart with an in-clinic period.
- An outpatient Follow-up Period of approximately 20 weeks.
- Conditions
- Cardiovascular
- Being tested
- AZD1705, Placebo
- Keywords
- Dyslipidemia, Pharmacokinetics
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1705Drug
Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B.
PlaceboOther
Participants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (AZD1705) | Active comparator | Non-Asian participants will receive AZD1705 subcutaneously on Day 1. Receives: Drug: AZD1705 |
| Part A2 (AZD1705) | Active comparator | Japanese participants will receive AZD1705 subcutaneously on Day 1. Receives: Drug: AZD1705 |
| Part A3 (AZD1705) | Active comparator | Chinese participants will receive AZD1705 subcutaneously on Day 1. Receives: Drug: AZD1705 |
| Part B1 (AZD1705) | Active comparator | Non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. Receives: Drug: AZD1705 |
| Part B2 (AZD1705) | Active comparator | Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. Receives: Drug: AZD1705 |
| Part B3 (AZD1705) | Active comparator | Participants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive AZD1705 subcutaneously on Day 1 and Day 29. Receives: Drug: AZD1705 |
| Part A1 (Placebo) | Placebo comparator | Non-Asian participants will receive placebo on Day 1. Receives: Other: Placebo |
| Part A2 (Placebo) | Placebo comparator | Japanese participants will receive placebo on Day 1. Receives: Other: Placebo |
| Part A3 (Placebo) | Placebo comparator | Chinese participants will receive placebo on Day 1. Receives: Other: Placebo |
| Part B1 (Placebo) | Placebo comparator | Non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive placebo on Day 1 and Day 29. Receives: Other: Placebo |
| Part B2 (Placebo) | Placebo comparator | Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29. Receives: Other: Placebo |
| Part B3 (Placebo) | Placebo comparator | Participants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive placebo on Day 1 and Day 29. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD1705 following subcutaneous administration of single ascending doses (Part A) and multiple ascending doses (Part B) in participants with dyslipidemia
Measured: Part A: From Screening (Day -60 to Day -2) until Day 113. Part B: From Screening until Day 141
Secondary outcomes (10)
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 113. Part B: Day 1 to 141
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 113. Part B: Day 1 to 141
Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 113. Part B: Day 1 to 141
Cumulative amount of drug excreted unchanged (Ae)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Fraction of drug excreted unchanged (fe)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Rate of renal clearance of drug (CLR)
To characterize the single and repeated dose PK of AZD1705 following subcutaneous administration in participants with dyslipidemia.
Measured: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Change from baseline in target plasma protein
To assess the effect of single and repeated subcutaneous AZD1705 administration on target plasma protein levels in participants with dyslipidemia.
Measured: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
To assess the effect of single and repeated subcutaneous AZD1704 administration on levels of LDL-C in circulation in participants with dyslipidemia.
Measured: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in Apolipoprotein B (ApoB)
To assess the effect of single and repeated subcutaneous AZD1704 administration on levels of ApoB in circulation in participants with dyslipidemia.
Measured: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in triglycerides
To assess the effect of single and repeated subcutaneous AZD1704 administration on levels of triglycerides in circulation in participants with dyslipidemia.
Measured: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start16 Jan 2024
- Primary completion1 Dec 2025
- Study completion8 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiovascularStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238466
- Sponsor's protocol ID
- D7650C00001
- Status last verified
- Aug 2026
- First submitted
- 25 Jan 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Vivli.org. All requests 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1705 Following Single and Multiple Ascending Doses in Participants With Dyslipidemia
- ClinicalTrials.gov ID
- NCT06238466
- Acronym / sponsor ID
- D7650C00001
- Conditions
- Cardiovascular
- Keywords
- Dyslipidemia, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 8 Apr 2027 (estimated)
- First posted
- 2 Feb 2024 (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.
A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.
Detailed description
This is a first time in human study in male and female (of non-childbearing potential) participants with dyslipidemia. The study consists of two parts:
- Part A (single ascending dose): Part A of the study will include three parts: A1 for non-Asian participants, A2 for Japanese participants, and A3 for Chinese participants. Parts A2 and A3 are optional.
- Part B (multiple ascending dose): Part B of the study will include three parts: B1 for non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy, B2 for Japanese participants not receiving statin therapy, and B3 for participants who may or may not be receiving moderate- or high-intensity statin therapy, with the additional diagnosis of type 2 diabetes (T2D), and with HbA1c < 8%. Parts B2 and B3 are optional.
The study will comprise of:
- A Screening Period of maximum 60 days for both Part A and Part B.
- Part A: A single dose of AZD1705 with an in-clinic period of 3 days.
- An outpatient Follow-up Period of approximately 16 weeks.
- Part B: 2 doses of AZD1705, given 28 days apart with an in-clinic period.
- An outpatient Follow-up Period of approximately 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A1 (AZD1705) | Active comparator | Drug: AZD1705Non-Asian participants will receive AZD1705 subcutaneously on Day 1. |
| Part A2 (AZD1705) | Active comparator | Drug: AZD1705Japanese participants will receive AZD1705 subcutaneously on Day 1. |
| Part A3 (AZD1705) | Active comparator | Drug: AZD1705Chinese participants will receive AZD1705 subcutaneously on Day 1. |
| Part B1 (AZD1705) | Active comparator | Drug: AZD1705Non-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. |
| Part B2 (AZD1705) | Active comparator | Drug: AZD1705Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29. |
| Part B3 (AZD1705) | Active comparator | Drug: AZD1705Participants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive AZD1705 subcutaneously on Day 1 and Day 29. |
| Part A1 (Placebo) | Placebo comparator | Other: PlaceboNon-Asian participants will receive placebo on Day 1. |
| Part A2 (Placebo) | Placebo comparator | Other: PlaceboJapanese participants will receive placebo on Day 1. |
| Part A3 (Placebo) | Placebo comparator | Other: PlaceboChinese participants will receive placebo on Day 1. |
| Part B1 (Placebo) | Placebo comparator | Other: PlaceboNon-Asian participants who may or may not be receiving moderate- or high-intensity statin therapy will receive placebo on Day 1 and Day 29. |
| Part B2 (Placebo) | Placebo comparator | Other: PlaceboJapanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29. |
| Part B3 (Placebo) | Placebo comparator | Other: PlaceboParticipants who may or may not be receiving moderate- or high-intensity statin therapy and with the additional diagnosis of type 2 diabetes will receive placebo on Day 1 and Day 29. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male and female of non-childbearing potential participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test.
- Participants with elevated lipids.
- BMI between 18 and 35 kg/m^2.
- Part B1 - May or may not be receiving moderate- or high-intensity statin therapy.
Key exclusion criteria (45 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant'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.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any laboratory values with the following deviations at the Screening Visit or on admission to the Clinical Unit. Abnormal values may be repeated once at the discretion of the Investigator:
- Any clinically important abnormalities in hematology, coagulation, clinical chemistry, or urinalysis results other than those described under exclusion criterion number 4, at Screening and/or first admission to the study unit, as judged by the Investigator. Abnormal values may be repeated once at the discretion of the Investigator.
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 |
|---|---|---|
| AZD1705Participants will receive AZD1705 subcutaneously on Day 1 in Part A, and Days 1 and 29 in Part B. | Drug | Part A1 (AZD1705), Part A2 (AZD1705), Part A3 (AZD1705), Part B1 (AZD1705), Part B2 (AZD1705), Part B3 (AZD1705) |
| PlaceboParticipants will receive placebo on Day 1 in Part A, and Days 1 and 29 in Part B. | Other | Part A1 (Placebo), Part A2 (Placebo), Part A3 (Placebo), Part B1 (Placebo), Part B2 (Placebo), Part B3 (Placebo) |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Part A: From Screening (Day -60 to Day -2) until Day 113. Part B: From Screening until Day 141
To assess the safety and tolerability of AZD1705 following subcutaneous administration of single ascending doses (Part A) and multiple ascending doses (Part B) in participants with dyslipidemia
10 secondary outcomes
Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)
Time frame: Part A: Day 1 to 113. Part B: Day 1 to 141
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)
Time frame: Part A: Day 1 to 113. Part B: Day 1 to 141
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Part A: Day 1 to 113. Part B: Day 1 to 141
Cumulative amount of drug excreted unchanged (Ae)
Time frame: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Fraction of drug excreted unchanged (fe)
Time frame: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Rate of renal clearance of drug (CLR)
Time frame: Part A: Day 1 to 4. Part B: Day 1 to 4, and 29 to 30
Change from baseline in target plasma protein
Time frame: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in Apolipoprotein B (ApoB)
Time frame: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Change from baseline in triglycerides
Time frame: Part A: Baseline to Day 113. Part B: Baseline to Day 141
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- 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 Vivli.org. All requests 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 approved.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 AZD1705 in people with Cardiovascular, run by AstraZeneca at 5 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 14 inclusion and 45 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
This study is still under way. Results are not available in the source record yet.
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 participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Part A: From Screening (Day -60 to Day -2) until Day 113. Part B: From Screening until Day 141). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.