AZD1705 for Dyslipidemia

Not currently recruiting at 5 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Statins, Antacids, Analgesics, others

Disqualifiers: Gastrointestinal, Hepatic, Renal, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AZD1705 for individuals with dyslipidemia, a condition characterized by an imbalance of fats, such as cholesterol, in the blood. The main goal is to determine the safety of this treatment and its behavior in the body. Different groups in the trial will receive either AZD1705 or a placebo to compare results. Potential participants include those with high cholesterol levels, regardless of whether they are on other cholesterol-lowering medications, and some groups require a diagnosis of type 2 diabetes. As a Phase 1 trial, this research focuses on understanding how AZD1705 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial requires that participants be on stable medication for at least 3 months before joining and not change their medication or dose during the study. So, you can continue your current medications as long as they have been stable for the required time.

Is there any evidence suggesting that AZD1705 is likely to be safe for humans?

Research shows that AZD1705 remains in the early testing stages, so detailed safety information is limited. However, these early studies aim to determine the treatment's safety and tolerability. Participants have taken AZD1705 to observe their body's response. So far, no serious safety issues have emerged, which is encouraging. Since the study is in its early phase, it primarily focuses on identifying possible side effects and understanding the drug's mechanism in the body. While initial results are promising for safety, further research is necessary to fully assess the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD1705 for dyslipidemia because it represents a novel approach to managing cholesterol levels. Unlike the standard treatments, which often involve statin drugs that work by inhibiting cholesterol production in the liver, AZD1705 is administered subcutaneously and may offer a different mechanism of action, potentially targeting cholesterol in a new way. This could provide an alternative for patients who do not respond well to or cannot tolerate statins, offering hope for improved outcomes in managing dyslipidemia.

What evidence suggests that AZD1705 might be an effective treatment for dyslipidemia?

Research shows that AZD1705 is under study as a new treatment for dyslipidemia, which involves abnormal cholesterol levels in the blood. Although specific information about AZD1705 in humans remains limited, its development builds on other treatments targeting cholesterol. These treatments help lower LDL cholesterol, often called "bad" cholesterol, reducing the risk of heart disease. Early signs suggest that AZD1705 might offer similar benefits. The ongoing research in this trial aims to reveal more about its safety, mechanism in the body, and impact on cholesterol levels. Participants in this trial will receive either AZD1705 or a placebo, depending on their assigned treatment arm. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Japanese or Chinese adults with dyslipidemia who have stable veins for blood draws, are on a steady statin treatment for at least 3 months, and have a BMI of 18-35. Women must not be able to bear children and need a negative pregnancy test. Smokers or those with recent serious health issues can't join.

Inclusion Criteria

BMI between 18 and 35 kg/m^2

Participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese

Participants are to be Chinese, defined as having both parents and 4 grandparents who are Chinese

Exclusion Criteria

Contraindication to MRI as specified

I have no significant health issues that could affect the study.

I have a condition that affects how drugs are broken down in my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8-9 weeks

Treatment Part A

Participants receive a single ascending dose of AZD1705 or placebo with an in-clinic period of 3 days

3 days

Follow-up Part A

Participants are monitored for safety and effectiveness after the single dose treatment

16 weeks

Treatment Part B

Participants receive multiple ascending doses of AZD1705 or placebo, given 28 days apart with an in-clinic period

4 weeks

Follow-up Part B

Participants are monitored for safety and effectiveness after the multiple dose treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD1705

Trial Overview The study tests AZD1705's safety and how the body processes it in people with high lipid levels compared to a placebo (a substance with no active drug). Participants will randomly receive either AZD1705 or the placebo.

How Is the Trial Designed?

Group I: Part B2 (AZD1705) Active Control 1 Intervention

Japanese participants not receiving statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

Group II: Part B3 (AZD1705) Active Control 1 Intervention

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.

Group III: Part A1 (AZD1705) Active Control 1 Intervention

Non-Asian participants will receive AZD1705 subcutaneously on Day 1.

Group IV: Part A2 (AZD1705) Active Control 1 Intervention

Japanese participants will receive AZD1705 subcutaneously on Day 1.

Group V: Part A3 (AZD1705) Active Control 1 Intervention

Chinese participants will receive AZD1705 subcutaneously on Day 1.

Group VI: Part B1 (AZD1705) Active Control 1 Intervention

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.

Group VII: Part A3 (Placebo) Placebo Group 1 Intervention

Chinese participants will receive placebo on Day 1.

Group VIII: Part A2 (Placebo) Placebo Group 1 Intervention

Japanese participants will receive placebo on Day 1.

Group IX: Part A1 (Placebo) Placebo Group 1 Intervention

Non-Asian participants will receive placebo on Day 1.

Group X: Part B2 (Placebo) Placebo Group 1 Intervention

Japanese participants not receiving statin therapy will receive placebo on Day 1 and Day 29.

Group XI: Part B3 (Placebo) Placebo Group 1 Intervention

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.

Group XII: Part B1 (Placebo) Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials

322

Recruited

137,000+

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Published Research Related to This Trial

Primary dyslipidemias can lead to a higher risk of atherosclerotic vascular diseases, making it crucial to manage cholesterol and triglyceride levels effectively.

When lifestyle changes like diet and exercise are not enough to control lipid levels, pharmacologic treatments are necessary and can significantly lower the risks of serious health issues related to atherosclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of lipid disorders in patients with atherosclerotic vascular disease. Marks, AD.[2019]

Statins, a class of HMG-CoA reductase inhibitors, are highly effective in lowering LDL cholesterol levels and significantly reduce the risk of coronary heart disease and overall mortality, as demonstrated in large intervention studies.

Statins are generally well tolerated by patients, leading to high compliance rates, and preliminary results suggest they may also effectively reduce triglyceride levels in patients with hypertriglyceridemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical positioning of HMG-CoA reductase inhibitors in lipid management protocols. Cziraky, M.[2018]

Patients with type 2 diabetes benefit more from lipid-lowering treatments like ezetimibe and PCSK9 inhibitors due to their higher risk of atherosclerotic cardiovascular disease (ASCVD), as shown in recent clinical trials.

International guidelines now recommend a more aggressive approach to managing dyslipidaemia in diabetes, suggesting that additional therapies should be considered based on individual ASCVD risk and lipid levels, alongside lifestyle changes and statin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Best practice for treating dyslipidaemia in patients with diabetes based on current international guidelines. Lan, NSR., Burns, K., Bell, DA., et al.[2021]

Statins are effective for managing dyslipidemia in type 2 diabetes patients, but many do not reach their LDL-C goals, and about 20% experience muscle-related side effects, leading to statin intolerance.

New treatments like ezetimibe and PCSK9 monoclonal antibodies have shown significant cardiovascular benefits and a strong safety profile, offering alternative options for patients struggling with statin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Dyslipidemia in Type 2 Diabetes: Recent Advances in Nonstatin Treatment. Sugiyama, K., Saisho, Y.[2023]

Lowering low-density lipoprotein cholesterol (LDL-C) is crucial for reducing the risk of coronary heart disease (CHD), but addressing low high-density lipoprotein cholesterol (HDL-C) and high triglyceride (TG) levels is also important for comprehensive treatment.

Statins are effective first-line treatments for dyslipidemia, primarily lowering LDL-C while also positively affecting TG and HDL-C levels; however, combining statins with other therapies may improve lipid profiles but can lead to side effects and tolerability issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HDL-C and triglyceride levels: relationship to coronary heart disease and treatment with statins. Gaw, A.[2019]

Citations

1. withpower.com withpower.com/trial/phase-1-dyslipidemias-2024-b9f89

AZD1705 for Dyslipidemia · Info for Participants Statins, a class of drugs used to treat dyslipidemia, have been shown to effectively lower LDL cholesterol levels and reduce the risk of heart disease. They are ...

2. withpower.com withpower.com/trial/phase-1-dyslipidemias-2024-33b0c

AZD1705 for Dyslipidemia · Info for Participants The trial is testing AZD1705, a potential new treatment for dyslipidemia. It will compare how people respond to this drug versus a placebo.

3. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7650C00001

A study to investigate safety, tolerability, pharmacokinetics ... A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/AZD0780-a-novel-oral-PCSK9-inhibitor-demonstrated-significant-LDL-cholesterol-LDL-C-reduction-in-PURSUIT-Phase-IIb-trial.html

AZD0780, a novel oral PCSK9 inhibitor, demonstrated ... AZD0780 is an investigational once-daily oral PCSK9 inhibitor for patients currently not reaching their LDL-C lowering goal despite standard-of-care-lipid ...

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/azd-1705-astrazeneca-dyslipidemia-likelihood-of-approval/

AZD-1705 by AstraZeneca for Dyslipidemia: Likelihood of ... According to GlobalData, Phase I drugs for Dyslipidemia have a 68% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06238466

NCT06238466 | A Study to Investigate Safety, Tolerability ... Study Overview. Brief Summary. A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-to-investigate-safety-tolerability-pharmacokinetics-pharmacodynamics-trial-nct06216353

A Study to Investigate Safety, Tolerability ... Back to study results. A Phase 1 study of AZD1705 in dyslipidemia. A clinical study to evaluate the safety, tolerability, and effects of an investigational ...

8. astrazeneca.com astrazeneca.com/content/astraz/what-science-can-do/topics/disease-understanding/the-unmet-need-in-dyslipidaemia.html

Dyslipidaemia: Addressing Unmet Needs in Care and ... Dyslipidaemia, or a dysregulation in the levels of circulating lipids in plasma, is one of the most modifiable risk factors for cardiovascular ( ...