AZD5004 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and metabolism of a new drug, AZD5004, in healthy individuals. Participants will try different versions of AZD5004, both with and without food, to observe its effects on the drug's behavior. The trial suits healthy individuals without significant medical conditions and with a BMI between 23 and 35. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD5004 is generally safe and well-tolerated, whether taken with or without food. In previous studies, 50% of participants experienced side effects without food, while 64.3% had side effects with food. Nausea was the most common side effect.
AZD5004 shares a safety profile with other drugs in its class, known as GLP-1 receptor agonists, which treat type 2 diabetes and aid in weight management. Studies involving individuals with obesity and type 2 diabetes have confirmed its general tolerability. These findings suggest that AZD5004 is safe for most people and does not cause serious problems.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD5004 because it offers a unique approach to treatment. Unlike existing therapies, AZD5004 is being tested in different formulations and states (fasted vs. fed), which could optimize its effectiveness and absorption. This flexibility in administration could provide more tailored treatment options. Additionally, AZD5004's innovative formulations might offer distinct advantages over current medications, potentially leading to better patient outcomes.
What evidence suggests that this trial's treatments could be effective?
Research shows that AZD5004 mimics a hormone that helps control blood sugar and may aid in weight loss by regulating appetite. Studies have found it safe and well-tolerated in healthy individuals, with a clear understanding of its movement through the body. In an earlier trial, participants tolerated the drug well, and it showed promise in managing obesity and type 2 diabetes symptoms. Although human data remains limited, its mechanism suggests potential effectiveness for these conditions. Participants in this trial will receive different formulations of AZD5004 in various sequences to further evaluate its safety and pharmacokinetics.12678
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 with a BMI between 23 and 35, weighing at least 60 kg. Participants must not be pregnant or breastfeeding and must use effective birth control if sexually active. Suitable veins for blood draws are required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single-dose treatments of different AZD5004 formulations across 3 periods
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD5004
Trial Overview
The study tests how different oral forms of the drug AZD5004 are absorbed and processed in the body, as well as their safety, including whether taking them with food changes these effects. Only healthy volunteers participate.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen E (formulation 6, fed state), followed by Regimen D (formulation 6, fasted state).
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen D (formulation 6, fasted state), followed by Regimen E (formulation 6, fed state).
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen C (formulation 5, fed state), followed by Regimen B (formulation 5, fasted state) of AZD5004.
Participants will receive three treatments in sequence: Regimen A (formulation 1, fasted state), Regimen B (formulation 5, fasted state), followed by Regimen C (formulation 5, fed state) of AZD5004.
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Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
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
A Study to Investigate the Pharmacokinetics of Different ...
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to ...
AZD5004 for Healthy Subjects · Recruiting Participants ...
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the ...
A Study to Investigate the Pharmacokinetics of Different ...
A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years.
A Study to Investigate the Pharmacokinetics of Different ...
The purpose of this study is to assess the pharmacokinetics (PK), safety and tolerability of different oral formulations of AZD5004, and to evaluate the effect ...
Non‐clinical and first‐in‐human characterization of ECC5004 ...
Pharmacokinetic analysis—single ascending dose (SAD) study. Plasma concentration profiles of ECC5004 at doses from 1 to 300 mg in the SAD study in healthy ...
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 ...
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 ...
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ctv.veeva.com
ctv.veeva.com/study/efficacy-safety-and-tolerability-of-once-daily-oral-administration-of-azd5004-versus-placebo-for2Efficacy, Safety, and Tolerability of Once Daily Oral ...
... to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.
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