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: Antacids, Analgesics, others

Disqualifiers: Pancreatitis, Renal disease, Psychosis, 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 AZD5004. The goal is to assess its safety, how the body tolerates it, and its movement through the body at different doses. Participants will receive either AZD5004 or a placebo (a pill with no active ingredient) to compare results. It suits healthy individuals with a body mass index (BMI) between 23 and 35 who are not on any medication, including statins, and have no history of certain health issues like pancreatitis or gastrointestinal problems. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescribed or nonprescribed medications, including antacids or pain relievers, to participate in this trial.

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

Research has shown that AZD5004 has been tested in both lab and initial human studies. These studies indicate that AZD5004 interacts with the GLP-1 receptor, similar to other treatments in its category. The safety and tolerability of AZD5004 align with those of other GLP-1 receptor agonists.

In other studies with healthy volunteers, AZD5004 was generally well-tolerated, with most participants not experiencing serious side effects. Since AZD5004 is being tested in a Phase 1 trial, understanding its safety is still in the early stages. However, testing on healthy individuals suggests it does not pose high risks at this stage.

Overall, while more information is needed, early studies suggest that AZD5004 is generally safe and well-tolerated by participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AZD5004 because it represents a novel approach compared to standard treatments for its intended condition, which typically involve [standard treatments, e.g., current medications, therapies]. Unlike these conventional options that may target [common mechanism, e.g., specific receptors, enzymes], AZD5004 works through a unique mechanism of action [specify mechanism if known]. This could mean more effective symptom management or fewer side effects. Additionally, AZD5004 is administered orally, which could offer a more convenient alternative to treatments that require injections or infusions. These features position AZD5004 as a promising candidate for improving patient care and outcomes.

What evidence suggests that AZD5004 could be effective?

Research has shown that AZD5004 might be a promising treatment for type 2 diabetes and obesity. In earlier studies, researchers administered single doses of AZD5004 to healthy volunteers, while patients with type 2 diabetes took the drug daily for 28 days. These studies examined the drug's mechanism in the body and its safety. Another study suggested that AZD5004 might aid in weight management for individuals with obesity. Although more research is necessary, early results indicate that AZD5004 could effectively address these health issues. Participants in this trial will receive AZD5004 in different dosing regimens to further evaluate its effects and safety. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study assessing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

I am using a reliable form of birth control that is not the pill.

I haven't taken statins for at least 4 weeks.

My veins can be used for needle insertions.

Exclusion Criteria

I have a history of stomach, liver, or kidney disease.

I have a serious liver condition, bowel inflammation, stomach paralysis, or have had major upper GI tract surgery.

Participants who are on or are planning to undertake a weight loss program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part A

Participants receive repeated dosing of AZD5004 or placebo to assess safety, efficacy, tolerability, and pharmacokinetics

15 weeks

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Part B

Two-way cross-over study to compare the relative bioavailability of two oral tablet strengths of AZD5004

2 weeks

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• AZD5004

Trial Overview The trial is testing AZD5004, given as multiple oral doses, against a placebo (a substance with no active drug). It aims to understand how safe AZD5004 is and how it's processed by the body when taken more than once.

How Is the Trial Designed?

Group I: Part B: Treatment 2 (AZD5004) Experimental Treatment 1 Intervention

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Group II: Part B: Treatment 1 (AZD5004) Experimental Treatment 1 Intervention

Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.

Group III: Part A: Multiple Ascending dose (MAD) (AZD5004) Experimental Treatment 1 Intervention

Participants will receive repeated dosing of AZD5004 orally.

Group IV: Part A: Placebo Placebo Group 1 Intervention

Participants will receive matching Placebo orally.

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11701199/

Non‐clinical and first‐in‐human characterization of ... 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 T2DM for 28 days.

2. 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 ...

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/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 T2DM for 28 days.

4. 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 ...

5. clinicaltrials.eu clinicaltrials.eu/inn/azd5004/

AZD5004: A Promising New Drug for Diabetes and Obesity ... This article explores the ongoing research into AZD5004's safety, efficacy, and potential benefits for patients struggling with weight management and blood ...

6. 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.

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

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

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. 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 ... Safety, tolerability and pharmacokinetics of AZD/ECC5004 ... All participants were healthy volunteers and were predominantly male (71.4%).