AZD1705 for Dyslipidemia

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

112 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the drug AZD1705 for dyslipidemia?

The research highlights that new lipid-lowering agents, such as PCSK9 inhibitors and other novel drugs, have shown promising results in reducing LDL cholesterol levels, which is a key factor in managing dyslipidemia. These findings suggest that AZD1705, if it shares similar mechanisms or targets, could potentially be effective in treating dyslipidemia. ^{1 2 3 4 5}

What makes the drug AZD1705 unique for treating dyslipidemia?

The drug AZD1705 is unique for treating dyslipidemia because it may offer a novel mechanism of action or administration route compared to traditional treatments like statins, which are the current standard. While specific details about AZD1705 are not provided, it is being studied alongside a placebo, indicating it could be a new option in the landscape of lipid-lowering therapies. ^{2 3 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy of ezetimibe/simvastatin, rosuvastatin, and atorvastatin in uncontrolled hyperlipidemia patients. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

New Therapeutic Approaches in Treatment of Dyslipidaemia-A Narrative Review. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Antilipidemic Drug Therapy Today and in the Future. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Targeted Strategy in Lipid-Lowering Therapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

What's new in lipid management? [2019]

6. New Zealand 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. [2021]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Pharmacological targets for dislipidemies correction. Opportunities and prospects of therapeutic usage]. [2019]

8. England pubmed.ncbi.nlm.nih.gov

RNA interference to target lipid disorders. [2008]