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Study on the Effects of AZD5004 for Adults with Obesity or Overweight and a Related Medical Condition

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called AZD5004 for individuals living with obesity or who are overweight and have at least one related health condition, such as high blood pressure, high cholesterol, heart disease, or sleep apnea. The treatment being tested is a film-coated tablet taken by mouth. The purpose of the study is to determine if AZD5004 is more effective than a placebo in helping participants lose weight over a period of 26 weeks.

Participants in the study will be randomly assigned to receive either the AZD5004 tablet or a placebo. The study will last for a total of 36 weeks, during which participants will take the assigned tablet and attend regular check-ups to monitor their progress. The main focus will be on the change in body weight from the start of the study to week 26, as well as the proportion of participants who achieve at least a 5% weight loss by that time.

Throughout the study, researchers will also look at weight changes at week 36 and the number of participants who achieve greater weight loss milestones, such as 10% or 15% from their starting weight. This trial aims to provide valuable information on the safety and effectiveness of AZD5004 as a potential treatment option for weight management in individuals with obesity or overweight conditions.

1 joining the study

Upon joining the study, participants will be informed about the trial’s purpose, procedures, and potential risks and benefits. Participants will be required to sign an informed consent form, confirming their understanding and willingness to participate.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes measuring body mass index (BMI) and checking for any weight-related medical conditions such as hypertension or sleep apnea.

3 randomization

Participants will be randomly assigned to receive either the study medication, AZD5004, or a placebo. This process is double-blind, meaning neither the participants nor the researchers will know which treatment is being administered.

4 medication administration

Participants will take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol and will continue for a duration of 26 weeks.

5 regular check-ups

Throughout the trial, participants will attend regular check-ups to monitor their health and any changes in body weight. These visits will help assess the efficacy and safety of the treatment.

6 final assessment

At the end of the 26-week period, participants will undergo a final assessment to evaluate the percent change in body weight and the proportion of participants achieving at least 5% weight loss from baseline.

7 follow-up

Participants may be asked to return for follow-up visits at week 36 to assess longer-term effects of the treatment, including further weight changes and overall health status.

Who Can Join the Study?

  • Be at least 18 years old at the time of signing the informed consent.
  • Have a Body Mass Index (BMI) of at least 30 kg/m2, or a BMI of at least 27 kg/m2 with a current diagnosis of at least one of the following weight-related health issues:
    • Hypertension (high blood pressure)
    • Dyslipidemia or hyperlipidemia (abnormal levels of fats in the blood)
    • Cardiovascular (CV) disease (heart and blood vessel conditions)
    • Obstructive sleep apnea (a sleep disorder where breathing repeatedly stops and starts)
  • Have a stable body weight for 3 months before the screening, with no more than a 5% change in body weight.
  • Be capable of giving signed informed consent.
  • If female and able to have children, must use adequate contraception from enrollment through the study and after the last dose of the investigational medicine. Note: Oral contraceptives are not allowed.
  • If female and not able to have children, this criterion does not apply.
  • If male, must use condoms during the trial and after the last dose of the investigational medicine. Additional contraception must be used for sexual partners throughout the trial and after the last dose.

Who Cannot Join the Study?

  • Participants who do not have Obesity or are not Overweight with at least one other health condition cannot participate.
  • Participants who are not within the specified age range cannot participate.
  • Participants who are not willing to follow the study procedures cannot participate.
  • Participants who have any medical condition that the study doctors think might make it unsafe for them to participate cannot participate.
  • Participants who are pregnant or planning to become pregnant during the study cannot participate.
  • Participants who are currently participating in another clinical trial cannot participate.
  • Participants who have a history of certain medical conditions that might interfere with the study cannot participate.
  • Participants who are unable to give informed consent cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diabeteszentrum Hamburg West Hamburg Germany
Zentrum für klinische Studien Alexander Segner St. Ingbert Germany

Other Sites

Site Name City Country Status
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Klinische Forschung Berlin GbR Berlin Germany
Institut fuer Diabetesforschung Muenster GmbH Munster Germany
Cbp Cpjrfvjy Rqxstroy Sgepmbgf Moxccnao Gorc Mannheim Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
04.11.2024

Trial locations

Investigated drugs:

AZD5004 is a medication being studied to help people who are living with obesity or are overweight and have other health conditions. The main goal of this medication is to help people lose weight. In this clinical trial, researchers are trying to find out if AZD5004 can help people lose weight more effectively than a placebo, which is a substance with no active medication. They are also looking to see if AZD5004 can help a significant number of participants lose at least 5% of their body weight over a period of 26 weeks.

Investigated diseases:

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight. Obesity can progress gradually, often starting with weight gain and potentially leading to more severe health issues. It is commonly associated with various comorbidities, such as type 2 diabetes, hypertension, and cardiovascular diseases. The progression of obesity can vary among individuals, influenced by genetic, environmental, and lifestyle factors.

Overweight – Overweight is a condition where an individual has more body weight than is considered healthy for their height, primarily due to excess body fat. It occurs when there is a prolonged imbalance between calorie intake and energy expenditure. Over time, this can lead to an increase in body mass index (BMI), placing individuals at risk for developing obesity. The progression from being overweight to obesity can be gradual and is influenced by factors such as diet, physical activity, and genetics. Being overweight is often associated with an increased risk of developing health problems like cardiovascular disease and type 2 diabetes. The condition can vary in severity and impact depending on individual health and lifestyle choices.

Trial ID:
2024-513691-18-00
Protocol code:
D7260C00001
Trial Phase:
Therapeutic exploratory (Phase II)

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