AZD5004 for Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Antidepressants, Antipsychotics, others

Disqualifiers: Pancreatitis, GI disease, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how well a new medicine, AZD5004, is absorbed in the body when taken as a tablet. Researchers will test three different tablet forms to identify the most effective one. The trial is open to healthy individuals who weigh at least 60 kg (about 132 pounds) and have a Body Mass Index (BMI) between 23 and 35. Participants must have no significant health issues and be comfortable with frequent blood draws. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that AZD5004 is likely to be safe for humans?

Research shows that AZD5004 has been tested for safety in adults, including those with obesity. Previous studies found that AZD5004 is generally well-tolerated. Some participants experienced mild side effects, such as headaches or nausea, but these were not serious. No severe side effects were directly linked to the treatment in these studies.

Although this trial is in its early phase, often focusing on safety, past research provides some confidence in AZD5004's safety. However, this study remains important to confirm how well people handle different tablet forms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

AZD5004 is unique because it offers a new approach by potentially targeting the root cause of certain conditions rather than just alleviating symptoms. Unlike traditional treatments that often involve multiple doses over a long period, AZD5004 is administered in single doses, which might improve patient compliance and reduce side effects. Researchers are excited about its novel mechanism of action, which could offer more effective results and possibly faster relief compared to existing options.

What evidence suggests that this trial's treatments could be effective?

Research has shown that AZD5004, a treatment for controlling blood sugar, shows promise in early studies. Participants in this trial will receive AZD5004 in different treatment sequences to evaluate its safety and tolerability. Trials with healthy volunteers found AZD5004 to be as safe and well-tolerated as other similar treatments. This suggests it might be effective and relatively safe to use. Although more research is needed, these early results are encouraging regarding its potential effectiveness. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who meet specific health criteria set by the study's guidelines. The exact inclusion and exclusion criteria are not provided, but typically participants must have no significant medical conditions and be within a certain age range.

Inclusion Criteria

I cannot become pregnant.

I have veins suitable for repeated needle insertions.

Additional contraception must be used for the sexual partners of male study participants throughout the clinical study

Exclusion Criteria

I have no major illnesses or recent surgeries.

Known or suspected history of alcohol or drug abuse or excessive intake of alcohol

Excessive intake of caffeine-containing drinks or food

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

27 days

Treatment Period 1

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 2

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 3

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Treatment Period 4

Participants receive a single dose of AZD5004 in one of the formulations (F1, F3, or F4) under fasted or fed conditions

7 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 to 10 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AZD5004

Trial Overview The study is testing the relative bioavailability of AZD5004, which means it's looking at how well the drug is absorbed and becomes available in the body when taken as three different oral tablet formulations.

How Is the Trial Designed?

Group I: Treatment Sequence D Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F3 (fasted) (Treatment Period 1), Day 8 in F1 (fasted) (Treatment Period 2), on Day 15 in F4 (fasted) (Treatment Period 3) followed by Day 22 in F4 (fed) (Treatment Period 4) respectively.

Group II: Treatment Sequence C Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F4 (fed) (Treatment Period 1), on Day 8 in F3 (fasted) (Treatment Period 2, on Day 15 in F1 (fasted) (Treatment Period 3 followed by on Day 22 in F4 (fasted) (Treatment Period 4) respectively.

Group III: Treatment Sequence B Experimental Treatment 1 Intervention

Partcipants will receive single dose of AZD5004 on Day 1 in F4 (fasted) (Treatment Period 1), on Day 8 in F4 (fed) (Treatment Period 2), on Day 15 in F3 (fasted) (Treatment Period 3) followed by on Day 22 in F1 (fasted) (Treatment Period 4) respectively.

Group IV: Treatment Sequence A Experimental Treatment 1 Intervention

Participants will receive single dose of AZD5004 on Day 1 in F1 (fasted) (Treatment period 1), on Day 8 in F4 (fasted) (Treatment period 2), on Day 15 in F4(fed) (Treatment Period 3) followed by on Day 22 in F3 (fasted) (Treatment Period 4) respectively.

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

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7260C00004

A Study to Investigate Multiple Ascending Doses and ... The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39495140/

Non-clinical and first-in-human characterization of ... ECC5004 engaged the GLP-1R across the therapeutic dose range tested and had a safety and tolerability profile consistent with other GLP-1 RAs.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06555822

NCT06555822 | A Study to Investigate Multiple Ascending ... The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.16047

Non‐clinical and first‐in‐human characterization of ECC5004 ... This study evaluated single doses of ECC5004 (1–300 mg) in healthy volunteers, and multiple daily doses (5, 10, 30 and 50 mg) in patients with ...

5. eccogene.com eccogene.com/wp-content/uploads/OW-2024_ECC5004-Food-Effects-Poster_FINAL_24Oct2024-1.pdf

AZD5004/ECC5004, a Small Molecule GLP-1 Receptor ... All participants were healthy volunteers and were predominantly male (71.4%) and White (85.7%). • Participants had a mean age of 46.7 years (SD ...

6. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D7260C00001

Effects of AZD5004 in adults who are living with obesity ... A Phase IIb randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in participants living with obesity ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06579105

NCT06579105 | Efficacy, Safety, and Tolerability of Once ... This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06579105

NCT06579105 | Efficacy, Safety, and Tolerability of Once ... This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults ...

9. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-4-2025-ca923

AZD5004 for Healthy Subjects · Info for Participants The purpose of this study is to assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations ...