Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIb Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD5004 in Participants Living with Obesity or Overweight with Comorbidity

This research study, called a Phase IIb trial, is investigating a new medicine named AZD5004. It's designed for adults who are overweight or have obesity and are also dealing with other related health conditions. The main goal is to find out how much weight people lose with AZD5004 compared to a dummy pill (placebo) after 26 weeks. Researchers will also check if a significant number of participants lose at least 5% of their body weight. Importantly, the study will also look closely at how safe the medicine is and how well people tolerate it, meaning if they have side effects. Participants won't know if they are receiving the experimental medicine or the placebo.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

AstraZeneca AB

Enrolment target

Start

14 Oct 2024

Participants living with Obesity or Overweight with at least 1 comorbidity

What is this study about?

This study is looking into a new medicine called AZD5004. It's a type of research known as a Phase IIb trial. This means it's an important step in testing new medicines, where scientists are trying to understand more about its effects before it's tested on even more people.

The main purpose of this study is to see how well AZD5004 helps people who are overweight or have obesity also manage other related health problems. Researchers want to find out if taking this medicine helps people lose weight and, just as importantly, if it's safe to use and if people can take it without too many unwanted effects. They will compare the new medicine to a 'placebo', which looks like the real medicine but contains no active drug, to understand the true effects of AZD5004.

The study will follow participants for 26 weeks to see changes in their body weight. They will also continue to monitor for a further 10 weeks, up to 36 weeks in total, to see if weight loss is maintained and to continue checking safety. This information will help doctors understand if AZD5004 could be a helpful new treatment option for people living with these conditions.

Key takeaways

Tests a new medicine (AZD5004) for weight loss.
For adults who are overweight or have obesity and other health issues.
Compares AZD5004 to a dummy pill (placebo).
Looks at how much weight is lost and safety.
Lasts about 36 weeks with regular clinic visits.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit, so older adults can also take part.

To be considered for this study, you need to be living with obesity or be overweight. On top of that, you must also have at least one other health condition that is often linked with being overweight or having obesity. This could be conditions like high blood pressure, type 2 diabetes, or high cholesterol, for example.

Both men and women are welcome to participate in this study. The research team will carefully check everyone to make sure they meet all the health requirements to ensure the study is safe and effective for them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you considered overweight or do you have obesity?
Do you have at least one other health condition often linked to being overweight or having obesity (e.g., high blood pressure, type 2 diabetes)?
Are you able to attend regular clinic appointments for about 36 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned by chance (like flipping a coin) to either receive the new medicine, AZD5004, or a dummy pill called a placebo. Neither you nor your study doctor will know which you are receiving – this is called a 'double-blind' study and helps make the results fairer. You will take tablets each day.

Throughout the study, you will have regular visits to the clinic. At these visits, the study team will measure your weight, take blood samples, and ask you about your health and how you are feeling. This helps them track your progress and check for any side effects. These visits might involve physical examinations and other tests.

The main part of the study will last for 26 weeks, focusing on weight changes. However, you will continue to be monitored for another 10 weeks, making the total study duration 36 weeks. During this time, the team will continue to check your weight, health, and any changes. There will be follow-up calls or visits even after you stop taking the study medicine to make sure you are doing well.

Potential risks and benefits

Participating in a clinical trial may offer some potential benefits, such as access to a new medicine before it's widely available and closer monitoring of your health by medical professionals. For this study, if you receive AZD5004, it might help you lose weight. However, as with any medicine, there are potential risks, including side effects from AZD5004 or from the study procedures themselves. These will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a placebo?

A placebo is a fake medicine that looks exactly like the real medicine but doesn't contain any active drug. It helps researchers understand if the new medicine is truly causing any effects.

What does 'double-blind' mean?

Double-blind means that neither you, the participant, nor the study doctor knows whether you are receiving the active medicine or the placebo. This helps ensure the study results are unbiased.

How long will I be in the study?

The main treatment period for the study is 26 weeks, where researchers look at weight changes. You will then be followed for an additional 10 weeks, making the total commitment about 36 weeks.

What kind of health conditions are considered 'comorbidities' in this study?

Comorbidities are other health problems that often occur with being overweight or having obesity, such as high blood pressure, high cholesterol, or type 2 diabetes. The study team will assess if your conditions qualify.

Will I have to pay to participate?

No, you will not have to pay to participate in a clinical trial. The study sponsor covers the costs of the research medicine and study-related visits and tests.