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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

7 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Institut fuer Diabetesforschung Muenster GmbH
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Munster, Germany
Klinische Forschung Berlin GbR
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Berlin, Germany

Trial locations

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Investigated drugs

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.

What is already known about the treatment

AZD9550
A novel investigational drug currently in Phase IIb clinical trials for the treatment of obesity and overweight conditions with associated comorbidities. The medication is being studied in combination with AZD6234 to evaluate its effectiveness in promoting weight loss. While the exact mechanism of action is still under investigation in clinical trials, it is being developed as part of a dual-therapy approach to weight management.
AZD6234
An experimental pharmaceutical compound being studied in Phase IIb clinical trials as part of a combination therapy with AZD9550 for treating obesity and overweight conditions. The medication is being evaluated for its potential to help achieve significant weight reduction, specifically targeting a weight loss of 5% or more from baseline. The drug is currently undergoing rigorous testing to establish its safety profile and efficacy when used in conjunction with AZD9550.

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.