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Study of AZD6234 (lenbelintide) Added to Incretin Therapy in Adults with Obesity or Overweight and a Weight‑Related Comorbidity, With or Without Type 2 Diabetes

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What is this trial about?

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

The study focuses on adults who have Obesity or Overweight and may also have Type 2 Diabetes Mellitus. Participants are already taking medicines that belong to a group called incretin-based therapies. The investigational drug, identified as AZD6234, contains the active ingredient lenbelintide and is given as a small injection under the skin.

The purpose of the research is to find out whether adding AZD6234 to the usual treatment helps people lose more body weight compared with a placebo.

People who join the study are randomly placed into one of two groups: one group receives the AZD6234 injection and the other receives a placebo injection that looks the same. Neither the participants nor the study staff know which group each person is in. The injections are given regularly for about 68 weeks while participants continue their regular incretin‑based medicines. Throughout the study, participants attend clinic visits where their weight, waist size, blood pressure, and simple blood tests are checked to monitor safety and any changes.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening and baseline assessments
After joining the study, you will undergo screening procedures to confirm eligibility. this includes measurements of weight, waist size, blood pressure, blood tests for triglycerides and HbA1c, and an electrocardiogram (ecg). these results establish the baseline for later comparisons.
Step 2
Randomization to study medication
Once eligibility is confirmed, you will be randomly assigned to receive either azd6234 (containing the active substance lenbelintide) or a matching placebo. the assignment is double‑blind, so neither you nor the study staff will know which product you receive.
Step 3
Receiving the injection kit and instructions
You will be provided with a kit containing a solution for injection that is meant for subcutaneous use (injection under the skin). the kit includes clear instructions on how to prepare and administer the injection safely.
Step 4
Starting the treatment phase
You will begin injecting the study medication according to the schedule given by the study team. the exact dose and frequency are specified in the instructions, and the treatment continues for a total of 68 weeks.
If you are assigned to the placebo group, you will follow the same injection schedule with a solution that does not contain the active drug.
Step 5
Regular clinic visits for monitoring
Throughout the 68‑week period you will attend periodic clinic visits. during each visit the study staff will measure your weight, waist circumference, and blood pressure, and will collect blood samples to check triglycerides, HbA1c, and other laboratory values. an ecg may also be performed to monitor heart rhythm.
These visits are also used to review any side effects you may have experienced and to ensure the medication is being used correctly.
Step 6
Reporting side effects
Any adverse events, including symptoms that you consider unusual or uncomfortable, should be reported to the study staff promptly. this information helps assess the safety of the treatment.
Step 7
Continuing injections until week 68
You will keep administering the assigned injection for the full duration of the study, which ends at week 68. adherence to the injection schedule is important for accurate evaluation of the treatment effect.
Step 8
Final assessment at week 68
At the end of the 68‑week treatment period, a comprehensive evaluation will be performed. weight change, waist size, blood pressure, laboratory values, and ecg results will be compared with the baseline measurements to determine the effect of the study medication.
Step 9
Study completion and medication discontinuation
After the final assessment, you will stop receiving the study medication. the study team will provide any necessary follow‑up instructions and discuss the overall results of your participation.

Who can join the trial?

7 criteria

You must be 18 years old or older, regardless of gender.
Your body mass index (BMI) must be 30 kg/m² or higher, or it can be 27 kg/m² or higher if you have at least one weight‑related health problem such as high blood pressure (hypertension), high blood fats (dyslipidaemia), breathing problems during sleep (obstructive sleep apnoea), heart disease (cardiovascular disease), weak heart (heart failure), kidney disease (chronic kidney disease), fatty liver disease (metabolic dysfunction associated steatotic liver disease), or knee joint arthritis (osteoarthritis of the knee).
If you have type 2 diabetes (T2DM), you must have been diagnosed at least 90 days before the first study visit.
If you have T2DM, a blood test called HbA1c must be between 6.0% and 9.0% at the screening visit, and your diabetes must be controlled with diet, exercise, or a stable dose of oral diabetes medicines or incretin‑based medications.
You must have been taking a stable dose of incretin‑based medications for weight management for at least 3 months before the screening and randomisation visit.
Your body weight must not have changed by more than 3% in the 3 months before randomisation.
You must have tried at least once in your life to lose weight but were not successful.

Who cannot join the trial?

6 criteria

People whose obesity is mainly caused by other endocrine disorders (hormone problems) cannot join the study.
Anyone who has Type 1 diabetes (a condition where the body makes little or no insulin) is not eligible.
People with serious liver or bile‑duct disease (called hepatobiliary disease), including recent or long‑lasting inflammation of the liver (acute or chronic hepatitis), or who have any of the following lab results at screening are excluded:
- Blood level of ALT (a liver enzyme) that is 3 times higher than the normal upper limit (ULN).
- Blood level of AST (another liver enzyme) that is 3 times higher than the normal upper limit.
- Blood level of total bilirubin (a substance that makes bile yellow) that is more than 1.5 times the normal upper limit, unless the person has Gilbert’s Syndrome (a harmless condition that mildly raises bilirubin).
- Anyone who has used insulin therapy (injections that lower blood sugar) for type 2 diabetes within the three months before screening cannot take part in the trial.

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Verified sites

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CTC Clinical Trial Consultants AB
Verified
Uppsala, Sweden
Hvidovre Hospital
Verified
Hvidovre, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

AZD6234
is an investigational medicine that contains a substance called lenbelintide. It is given as a liquid that you inject under the skin (subcutaneous injection). In this study, the drug is being tested to see if it can help people with obesity or overweight lose weight when it is added to their usual diabetes or weight‑loss medicines. The researchers want to know whether adding AZD6234 can lead to a greater reduction in body weight over about 68 weeks compared with not adding it.
Incretin‑based therapies
are a group of medicines that work by enhancing the action of natural hormones (incretins) that help control blood sugar after meals. These medicines, such as GLP‑1 receptor agonists, are often used to treat type 2 diabetes and can also aid weight loss. In the trial, participants continue taking their regular incretin‑based therapy, and the study examines whether adding AZD6234 provides additional weight‑loss benefits beyond what the incretin medicines already provide.

AZD6234

What is already known about the treatment

AZD6234 - AZD6234 (lenbelintide) is supplied as a clear solution for injection that is administered under the skin (subcutaneous use). It is currently in Phase III clinical testing and has not yet received marketing approval. The medication is intended to aid adults who are obese or overweight with weight‑related health issues, with or without type 2 diabetes. Lenbelintide works by mimicking a natural hormone that reduces appetite, activating receptors that signal the brain to eat less, and it is classified as a peptide hormone (incretin) analog.

Investigated diseases

Obesity (including overweight) with or without type 2 diabetes mellitus - Obesity is a condition of excess body fat that results from an energy imbalance. It can develop gradually as calorie intake consistently exceeds expenditure. Over time, excess weight may cause metabolic changes such as insulin resistance, which can progress to type 2 diabetes mellitus in some individuals. Even without diabetes, the extra fat can accumulate in the abdomen and other areas, increasing waist circumference. The condition often worsens if lifestyle factors remain unchanged, leading to further weight gain and related health issues.