AZD1705 for Dyslipidemia

Not yet recruiting at 1 trial location

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must be taking: Statins

Must not be taking: 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 aims to test the safety and effects of a new treatment, AZD1705, for individuals with dyslipidemia, a condition involving abnormal levels of lipids (fats) in the blood. Researchers will divide participants into groups; some will receive AZD1705, while others will receive a placebo (a non-active substance). Ideal candidates have high lipid levels and, in some cases, are already on statin therapy or have type 2 diabetes. The research will focus on how the body processes and responds to AZD1705 to ensure its safety and effectiveness.

As a Phase 1 trial, participants will be among the first to receive AZD1705, aiding researchers in understanding how the treatment works in people.

Will I have to stop taking my current medications?

If you are participating in Part B1 or B3, you must continue taking your current statin medication without changing the dose. For Part A, you should not use any prescribed or nonprescribed medications, including herbal remedies, two weeks before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is investigating AZD1705 to determine its safety and how individuals with dyslipidemia (unusual blood fat levels) tolerate it. As this is an early trial, limited information exists on patient responses. However, early trials typically focus on ensuring the treatment does not cause harmful side effects. Researchers are carefully monitoring AZD1705 for any negative reactions. They will continue to assess the drug's safety and tolerability as more data becomes available. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dyslipidemia?

Researchers are excited about AZD1705 for dyslipidemia because it offers a unique approach compared to the standard treatments like statins and fibrates. Unlike these treatments, which primarily work by reducing liver cholesterol production or increasing cholesterol clearance, AZD1705 is administered subcutaneously, providing a different delivery method that might enhance patient adherence and efficacy. This investigational drug could potentially offer improved lipid management, particularly for patients who haven't responded well to traditional oral therapies.

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

Research shows that AZD1705 is a new treatment under testing for dyslipidemia, a condition characterized by excessive fat in the blood. This trial includes various treatment arms where participants receive either AZD1705 or a placebo. AZD1705 is designed to lower bad cholesterol levels, similar to statins. Although its effectiveness in people is still under investigation, the drug aims to assist those not meeting their cholesterol goals with current treatments. Early study results suggest that AZD1705 could be promising for managing cholesterol levels, but further information is needed to confirm these initial findings. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with dyslipidemia, a condition where there's an abnormal amount of lipids in the blood. Participants should meet specific health criteria set by the study but these aren't detailed here.

Inclusion Criteria

All females must have a negative pregnancy test

BMI between 18 and 35 kg/m^2

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

Exclusion Criteria

I have no conditions that affect how my body handles medicine.

I haven't had any major illnesses or surgeries in the last 4 weeks.

Judgment by the Investigator that the participant should not participate in the study if they have any ongoing or recent minor medical complaints

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment Part A

Single ascending dose of AZD1705 with an in-clinic period of 3 days

3 days

In-clinic stay

Follow-up Part A

Outpatient follow-up period after single dose administration

16 weeks

Treatment Part B

Multiple ascending doses of AZD1705, given 28 days apart with an in-clinic period

4 weeks

In-clinic stay

Follow-up Part B

Outpatient follow-up period after multiple dose administration

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AZD1705
• Placebo

Trial Overview The trial is testing AZD1705, a potential new treatment for dyslipidemia. It will compare how people respond to this drug versus a placebo (a substance with no active drug).

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 A1 (AZD1705) Active Control 1 Intervention

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

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

Japanese participants will receive AZD1705 subcutaneously on Day 1.

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

Non-Asian participants who are receiving moderate- or high-intensity statin therapy will receive AZD1705 subcutaneously on Day 1 and Day 29.

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

Participants who are 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 VI: Part A3 (AZD1705) Active Control 1 Intervention

Chinese participants will receive AZD1705 subcutaneously on Day 1.

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 B3 (Placebo) Placebo Group 1 Intervention

Participants who are 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 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 A1 (Placebo) Placebo Group 1 Intervention

Non-Asian participants will receive placebo on Day 1.

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

Non-Asian participants who are 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

Saroglitazar, a novel PPAR agonist, was found to be rapidly absorbed and well tolerated in a phase 1 study involving 96 healthy subjects, with no serious adverse events reported, indicating its safety for further development.

The pharmacokinetics of saroglitazar support a once-daily dosing schedule, as it showed a dose-related increase in plasma concentration and a terminal half-life of approximately 5.6 hours, making it suitable for managing dyslipidaemia in type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety, and tolerability of saroglitazar (ZYH1), a predominantly PPARα agonist with moderate PPARγ agonist activity in healthy human subjects. Jani, RH., Kansagra, K., Jain, MR., et al.[2021]

The review highlights various existing and new drug preparations for correcting dyslipidemias, focusing on their molecular mechanisms and potential pharmacological targets.

It suggests that activating the functionality of high-density lipoproteins (HDL) and exploring alternative treatments with novel mechanisms could enhance the effectiveness of traditional dyslipidemia therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological targets for dislipidemies correction. Opportunities and prospects of therapeutic usage]. Kudinov, VA., Zakharova, TS., Torkhovskaya, TI., et al.[2019]

In a study of high-risk patients switched from simvastatin therapy, the combination of ezetimibe/simvastatin led to significantly greater reductions in LDL cholesterol (37 mg/dL) compared to rosuvastatin (25 mg/dL) and atorvastatin (26 mg/dL).

All treatment regimens improved other lipid parameters, such as total cholesterol and triglycerides, with no significant differences in adverse events among the different therapies, indicating a similar safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of ezetimibe/simvastatin, rosuvastatin, and atorvastatin in uncontrolled hyperlipidemia patients. Furman, A., Meier, JL., Malmstrom, RA., et al.[2018]

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 ... Also called a data safety ... A study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD1705 in participants with dyslipidemia.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06238466/a-study-to-investigate-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-azd1705-in-participants-with-dyslipidemia?state=MD&city=Brooklyn

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