Study of AZD9550 and AZD6234 combination for weight loss in people with obesity or overweight with health complications

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What is this study about?

This clinical trial investigates the effectiveness of medications for treating obesity and being overweight with related health conditions. The study tests two experimental medications, AZD9550 and AZD6234, given as injections under the skin, both individually and in combination. Some participants will receive placebo instead of active medication.

The main purpose is to determine if using both medications together leads to greater weight loss compared to using placebo or single medications alone. The study will measure how much weight participants lose over 36 weeks of treatment. During the study, participants may also receive other medications if needed, including ondansetron, cyclizine, calcium citrate, glucose, glucagon, and various forms of calcium supplements.

Throughout the study, researchers will monitor participants’ weight changes and check for any side effects from the medications. They will also look at how many participants achieve different levels of weight loss and examine how the body responds to the medications by testing for certain proteins in the blood.

1 Initial screening and assessment

Your eligibility for the study will be assessed based on the following criteria:

Age between 18 and 75 years

Body Mass Index (BMI) must be either ≥30, or ≥27 with at least one weight-related health condition

Your weight should have been stable for 3 months before screening

A blood pregnancy test will be performed for female participants

You must be able to provide informed consent

2 Treatment period initiation

The treatment period will last for 36 weeks

You will be randomly assigned to receive one of the following treatments:

AZD9550 and AZD6234 in combination (given by injection under the skin)

– Placebo (inactive substance)

– Individual treatments of either AZD9550 or AZD6234

3 Regular monitoring

Your weight will be measured regularly throughout the 36-week period

Your body weight changes will be tracked and recorded

The medical team will monitor your progress and any potential side effects

Blood tests will be conducted to check for antibodies to the study medications

4 Final assessment

After 36 weeks, final measurements will be taken to evaluate:

The percentage and actual change in your body weight

Whether you achieved weight loss of 5% or more

Whether you achieved weight loss of 10% or 15% or more

The safety and tolerability of the treatment you received

Who Can Join the Study?

  • Age requirement: Must be between 18 and 75 years old
  • Body Mass Index (BMI) requirements:
    • Either BMI of 30 kg/m² or higher, or
    • BMI of 27 kg/m² or higher with at least one health condition related to weight
  • Weight stability: Must have maintained a stable body weight for at least 3 months before screening
  • Contraception requirements:
    • Both men and women must use appropriate contraception methods according to local guidelines
    • Women must have a negative pregnancy test at screening and at the start of the study
  • Must be able to understand and provide informed consent to participate in the study

Who Cannot Join the Study?

  • Body Mass Index (BMI) less than 30 kg/m² or greater than 50 kg/m²
  • History of bariatric surgery (weight loss surgery) or planning such surgery during the study
  • Current participation in any weight loss program or using weight loss medications
  • Significant changes in body weight (more than 5%) in the past 3 months
  • Diagnosed with type 1 diabetes
  • Uncontrolled type 2 diabetes (HbA1c greater than 9%)
  • History of heart problems including heart attack or stroke in the past 6 months
  • Uncontrolled high blood pressure (blood pressure above 160/100 mmHg)
  • Severe kidney or liver disease
  • Current or history of eating disorders
  • Pregnancy, breastfeeding, or planning pregnancy during the study period
  • Current substance abuse or alcohol dependency
  • Any medical condition that could interfere with the study results or participant safety
  • Taking medications that could significantly affect body weight
  • Unable to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
InnoDiab Forschung GmbH Essen 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
Gemeinschaftspraxis für Innere Medizin und Diabetologie Hamburg Germany
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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
21.02.2025

Trial locations

AZD9550 is an investigational medication being studied for weight loss in people with obesity or overweight conditions. It is being tested in combination with another medication to evaluate its effectiveness in helping patients reduce their body weight.

AZD6234 is another investigational medication that is being studied together with AZD9550. This combination therapy is being evaluated to determine how well it works for weight management in people who are living with obesity or who are overweight with additional health conditions.

The combination of these two medications is being tested to see if it can help patients achieve significant weight loss, particularly focusing on helping patients lose 5% or more of their initial body weight.

Investigated diseases:

Obesity – A chronic medical condition characterized by excessive accumulation of body fat that can affect overall health. The condition develops when calorie intake consistently exceeds calorie expenditure, leading to weight gain over time. Body fat accumulates throughout the body, particularly in the abdomen, under the skin, and around internal organs. Obesity often progresses gradually and can be influenced by genetic factors, lifestyle choices, and environmental conditions. The condition is typically measured using Body Mass Index (BMI), with a BMI of 30 or greater indicating obesity.

Overweight – A condition where a person’s body weight is higher than what is considered healthy for their height, but not as severe as obesity. It is characterized by an excess accumulation of body fat, though to a lesser degree than obesity. The condition is typically defined by a Body Mass Index (BMI) between 25 and 29.9. Overweight status can develop gradually through an imbalance between caloric intake and energy expenditure. The condition may be influenced by various factors including diet, physical activity levels, and genetic predisposition.

Trial ID:
2024-516176-15-00
Protocol code:
D8460C00004
NCT ID:
NCT06862791
Trial Phase:
Therapeutic exploratory (Phase II)

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