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RecruitingPHASE1INTERVENTIONAL

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.

This early-stage study is testing a new medication, AZD1043, for healthy adults who are overweight or have obesity. The main goals are to check its safety, see how well people tolerate it, and understand how it works in the body after single and repeated doses. Some participants will receive the active medication, while others will get a placebo (a dummy treatment). This study helps researchers learn if AZD1043 could be a potential new treatment and is the first time it’s being given to people, including those of Japanese and Chinese descent. All participants will be closely monitored for their well-being.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
AstraZeneca
Enrolment target
104
Start
30 Mar 2026
Estimated completion
21 Oct 2027

What is this study about?

This research is an early-stage study, often called a 'Phase 1' trial. This means it's one of the first times a new experimental medication, known as AZD1043, is being given to people. The main purpose is to understand if this new medication is safe and how well people tolerate it. Researchers will also look at how much of the medication the body absorbs, how it's distributed and broken down, and how it affects the body. This information is crucial for deciding if the medication can move on to larger studies.

The study involves healthy adult volunteers who are overweight or have obesity. Some participants will receive a single dose of AZD1043, while others will receive multiple doses over time. To make sure the results are as clear as possible, some participants will receive a 'placebo' – this looks exactly like the study medication but contains no active drug. This allows researchers to compare the effects of AZD1043 against no treatment. Parts of the study are specifically designed to include people of Japanese and Chinese descent to see if there are any differences in how the medication affects them.

This study is fundamental to drug development. By carefully evaluating AZD1043 in healthy volunteers first, scientists can gather important safety data and learn about its basic effects before considering it for wider use. It's a key step in developing new potential treatments, and participant safety and well-being are the top priority throughout the entire study.

Key takeaways

  • This is an early-stage UK study for a new medication (AZD1043).
  • It's for healthy adults (18-65) who are overweight or have obesity.
  • The main goals are to check safety, how well it's tolerated, and how the body handles the medication.
  • Participants may receive the active medication or a placebo (dummy treatment).
  • Close medical monitoring will be provided throughout your participation.
  • You have the right to leave the study at any time.

Who may be eligible?

To join this study, adult men and women between 18 and 65 years old are welcome. Women who participate must not be able to become pregnant, either because they have gone through menopause or have had surgery that prevents pregnancy. All participants will need to have a Body Mass Index (BMI) that falls within a specific range, generally between 25 and 39.9, but for those of Japanese or Chinese background, it might be slightly lower, starting at 23. You also need to weigh at least 50 kg (about 7 stone 12 pounds).

There are also specific requirements for participants of Japanese and Chinese descent; they need to have parents and grandparents who are ethnically Japanese or Chinese. This helps researchers understand if the medication works differently in these groups.

However, some conditions would prevent you from taking part. You can't have any serious ongoing medical conditions, particularly those affecting your stomach, liver, or kidneys, or any other health issues that might interfere with how your body handles medications. You also can't have had any significant illnesses, surgeries, or major injuries in the month leading up to the study. If you have a history of serious allergies to similar medications or if you've recently used weight loss medications, you wouldn't be able to join. Lastly, specific mental health conditions like psychosis, bipolar disorder, or major depression would also prevent your participation.

Quick self-check
  • Are you between 18 and 65 years old?
  • Are you generally healthy, with no significant ongoing medical conditions?
  • If you are a woman, are you unable to become pregnant (e.g., post-menopause or had relevant surgery)?
  • Is your Body Mass Index (BMI) within the range for overweight or obesity (generally 25-39.9)?
  • Have you avoided weight loss medications in the last 3 months?
  • Do you have no history of serious allergies to similar medications?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will first go through a screening period that can last up to 5 weeks. During this time, doctors will check your health to make sure the study is suitable for you. This will involve various assessments and tests.

Once you’ve been accepted, you'll enter the 'treatment period'. Depending on the part of the study you're in, you will either receive a single dose of the study medication (AZD1043) or a dummy treatment (placebo), or you will receive multiple doses. You'll be closely monitored by the study team, likely staying at a clinical unit for a period to ensure your safety and to collect important information about how the medication affects you. You will only participate in one part of the study, meaning you will either receive single doses or multiple doses, but not both.

After the treatment period, there will be a 'safety follow-up period'. This is where the study team will continue to monitor your health and well-being for a short time to make sure there are no delayed effects from the medication. Throughout your participation, regular check-ups and assessments will be carried out to keep a close eye on your health. The total duration of your involvement, including screening, treatment, and follow-up, will be explained in detail before you agree to participate.

Potential risks and benefits

Participating in any clinical study carries potential benefits and risks. A potential benefit of this study is that you would receive close medical monitoring and contribute to scientific knowledge that could lead to new treatments in the future. However, there is no guarantee that you will receive the active medication, as some participants will be given a placebo. Potential risks include experiencing side effects from the study medication, which at this early stage may not be fully known, or discomfort from medical procedures like blood tests. Your health and well-being are paramount, and you will be closely monitored throughout. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

  • Research Site
    Glendale, United States· Recruiting
  • Research Site
    Harrow, United Kingdom· Not yet recruiting

Common questions

What is AZD1043?

AZD1043 is an experimental new medication that is being tested for the first time in people, specifically those who are overweight or have obesity.

Will I definitely receive the new medication?

Not necessarily. This study includes a placebo, which looks like the active medication but contains no drug. This helps researchers compare the effects.

What does a 'Phase 1' study mean?

Phase 1 means this is one of the very first times the medication is being given to people. The main goals are to check its safety, how well people tolerate it, and how the body handles it.

How long would I be involved in the study?

Your involvement would include a screening period (up to 5 weeks), a treatment period, and a safety follow-up period. The exact length depends on which part of the study you join.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Investigate Safety, Tolerability, Pharmacokinetic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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