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Effect of lenbelintide (AZD6234) on body weight in adults with type 2 diabetes and obesity or overweight

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What is this trial about?

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

People with Type 2 Diabetes Mellitus who are also dealing with obesity or overweight have higher risks of heart problems and other health issues. This study examines a new injectable medicine called AZD6234, which contains the active substance lenbelintide. The medication is given under the skin, and some participants receive a harmless placebo that looks the same but does not contain the active drug.

The main aim of the trial is to see how well the medicine helps participants lose weight over about 68 weeks. Researchers will look at the percentage of weight loss, as well as other factors such as changes in blood sugar control measured by haemoglobin A1C, waist size, levels of blood fats called triglycerides, and the force of the heart’s pumping measured by systolic blood pressure. In a smaller group, the amount of body fat will be measured with a scan called DXA, which provides a detailed picture of body composition.

During the study, participants receive either the study drug or the placebo regularly for the duration of the trial, with scheduled visits to check safety, collect blood samples, and record vital signs such as blood pressure and pulse. These visits also allow researchers to monitor any side effects and ensure the treatment is well‑tolerated.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit

    You attend the first study visit after joining the trial. during this visit, study staff measure your weight, waist size, blood pressure, and take blood samples to check your blood sugar and other laboratory values. you also answer questions about your health and receive information about the study procedures.

  2. Step 2

    Randomization

    After the baseline assessments, you are randomly assigned to receive either azd6234 (which contains the active substance lenbelintide) or a matching placebo. the assignment is double‑blind, meaning neither you nor the study staff know which product you receive.

  3. Step 3

    Start of study medication

    You begin receiving a subcutaneous injection (injection under the skin) of the assigned product. the injection is a solution for injection with a concentration of 00 mg/ml. the exact dose, frequency, and schedule are provided by the study team and must be followed for the entire treatment period of 68 weeks.

  4. Step 4

    Regular follow‑up visits

    You attend scheduled clinic visits throughout the study, typically at weeks 4, 12, 24, 36, 52, and 68. at each visit, staff measure your weight, waist circumference, and blood pressure, collect blood samples, and ask about any side effects or health changes. these visits help monitor the safety and effectiveness of the medication.

  5. Step 5

    Daily self‑monitoring

    You record your weight regularly, often daily or weekly, and note any symptoms or adverse events you experience. if you notice any concerning changes, you report them to the study team according to the instructions provided.

  6. Step 6

    End of treatment

    After completing 68 weeks of treatment, you stop receiving the study medication. a final assessment is performed to measure body weight change, blood sugar control, and other health parameters. the study staff also review any remaining safety information.

  7. Step 7

    Post‑study follow‑up

    You may be asked to attend one or more additional visits after the treatment phase to ensure continued safety and to collect long‑term data. these visits are optional and follow the same procedures as earlier follow‑up visits.

Who can join the trial?

6 criteria

  • Be 18 years old or older, for both men and women.
  • Have a Body Mass Index (BMI) of 27 kg/m² or higher. (BMI is a number that compares your weight to your height.)
  • Have been diagnosed with Type 2 diabetes (T2DM) at least 90 days before the screening visit.
  • Have a screening HbA1c level between 6.0 % and 10.0 %. (HbA1c is a blood test that shows your average blood‑sugar level over the past 2‑3 months.) Your diabetes must be controlled with diet and exercise alone, or with a stable dose of any oral medicine that lowers blood sugar.
  • Have a stable body weight, meaning your weight has not changed by more than 5 % in the three months before randomisation. (Randomisation is the process that decides whether you receive the study drug or a placebo.)
  • Have tried at least once on your own to lose weight and been unable to keep it off.

Who cannot join the trial?

5 criteria

  • Having obesity that is mainly caused by other endocrine disorders (problems with hormone‑producing glands) disqualifies you.
  • Having Type 1 diabetes mellitus or any kind of diabetes that is not clearly Type 2 diabetes, or having had a serious episode of ketoacidosis (a dangerous buildup of acids in the blood) or a hyperosmolar coma (extremely high blood sugar leading to loss of consciousness) within the past 3 months means you cannot join.
  • Having serious hepatobiliary disease (important liver or bile‑duct problems) or showing any of these lab results at screening: ALT (a liver enzyme) three times higher than the normal upper limit, AST (another liver enzyme) three times higher than normal, or TBL (total bilirubin, a substance processed by the liver) more than 1.5 times the normal level (unless you have the harmless condition called Gilbert’s Syndrome) excludes you.
  • If you have taken any medication that works as a GLP‑1 receptor agonist or contains GLP‑1 (a type of drug that helps control blood sugar) for any reason within the 3 months before randomisation, you cannot participate.
  • Using insulin therapy to treat Type 2 diabetes mellitus (T2DM) within the 3 months before screening also makes you ineligible.
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Investigated drugs

AZD6234 is an experimental medicine that contains the active ingredient lenbelintide. It is given as a clear liquid that is injected under the skin. In this study, the drug is being tested to see if it can help people with type 2 diabetes who are also overweight or obese lose weight and improve their blood‑sugar control over a period of about 68 weeks. Participants receive the medication regularly throughout the trial, and researchers compare their results to those of participants who receive a matching placebo.

What is already known about the treatment

  • AZD6234

    AZD6234 (lenbelintide) is given as a subcutaneous injection solution. It is an experimental drug that is still being studied in clinical trials and is not yet approved for routine medical use. The medication is being tested for treating obesity and type 2 diabetes by helping reduce body weight and improve blood‑sugar control. It works by activating the GLP‑1 (glucagon‑like peptide‑1) receptor, which increases insulin release and slows stomach emptying, and it belongs to the class of GLP‑1 receptor agonists.

  • Placebo to match AZD6234

    The placebo is an inert solution that looks identical to AZD6234 and is administered by subcutaneous injection. It contains no active drug and is used only as a control in the trial. It has no therapeutic effect on obesity or diabetes and does not belong to any pharmacological class. Its purpose is to provide a neutral comparison so researchers can see how AZD6234 performs versus a non‑active treatment.

Investigated diseases

  • Obesity

    Obesity is a condition in which excess body fat accumulates to a degree that may affect health. It develops when energy intake consistently exceeds energy expenditure over time. The excess fat is stored primarily under the skin and around internal organs. As weight increases, the body may experience reduced mobility and strain on joints. The condition can become more severe if calorie imbalance continues, leading to larger increases in body size.

  • Type 2 diabetes mellitus

    Type 2 diabetes mellitus is a chronic disorder characterized by high blood sugar due to insulin resistance and relative insulin deficiency. It usually begins with the body's cells responding less effectively to insulin, prompting the pancreas to produce more. Over time, the pancreas may be unable to keep up with the demand, causing persistent elevated glucose levels. The disease often progresses slowly, with blood sugar gradually worsening if not managed. Persistent high glucose can affect many organs as the condition advances.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524616-11-00Protocol codeD8750C00012Estimated enrolment1 175 patientsSponsorAstraZeneca AB

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