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A Phase III Study of Lenbelintide in Adults with Obesity or Overweight and Weight‑Related Comorbidity 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 are overweight and have at least one health problem related to excess weight, but who do not have type 2 diabetes. The main goal is to find out whether the experimental drug can produce a greater loss of body weight compared with doing nothing special over a period of about 68 weeks.

Participants receive either the test medication AZD6234, which contains the active substance lenbelintide, or a matching placebo. The drug is supplied as a liquid that is injected just under the skin (subcutaneous injection). Doses are given at regular clinic visits throughout the study.

After an initial screening, individuals are randomly assigned to one of the two groups and then followed for the 68‑week treatment phase. During this time, their weight, waist size, blood pressure, blood fats such as triglycerides, and other health checks are recorded at scheduled visits. Body composition is also measured using a special scan called DXA. The study ends after the final assessments at week 68.

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

    Randomization and Assignment to Treatment

    You are randomly assigned to receive either AZD6234 or a matching placebo. The randomization is double‑blind, meaning neither you nor the study staff know which product you receive.

  2. Step 2

    Baseline Assessments

    Before the first dose, you undergo measurements of body weight, waist circumference, blood pressure, blood tests, and a body‑composition scan called DXA (a simple scan that measures fat and lean tissue).

    These results serve as the reference point for all future comparisons during the 68‑week study period.

  3. Step 3

    First Administration of Study Medication

    You receive the study medication by subcutaneous injection (injection under the skin).

    The medication is a solution for injection containing the active substance lenbelintide and is labeled AZD6234. The concentration is 00 mg/ml as specified in the study documentation.

    If you are assigned to the placebo group, you receive an injection that looks identical but contains no active drug.

  4. Step 4

    Regular Clinic Visits for Monitoring

    You attend scheduled clinic visits throughout the trial. During each visit, the study team measures your weight, waist circumference, and blood pressure, and draws blood for laboratory tests.

    The visits also allow the team to record any side effects you may experience and to ensure the medication is being used correctly.

  5. Step 5

    Ongoing Treatment Period

    You continue to receive the assigned injection according to the schedule defined by the study protocol for a total duration of 68 weeks.

    The injections are administered regularly (the exact frequency is defined by the protocol) and you remain under observation for safety and effectiveness throughout this period.

  6. Step 6

    Final Efficacy and Safety Evaluation at Week 68

    At the end of week 68, you undergo the same set of assessments performed at baseline, including weight, waist circumference, blood pressure, laboratory tests, and a DXA scan.

    These data are used to determine the percent change in body weight and other secondary outcomes such as achievement of 5 % or 10 % weight loss.

  7. Step 7

    Study Completion and Discontinuation of Medication

    After the final assessments, the study medication is stopped.

    You receive information about any follow‑up care that may be needed, and the study records are closed for your participation.

Who can join the trial?

4 criteria

  • You must be 18 years old or older, and any gender identity is accepted.
  • Your body mass index (BMI) must be 30 kg/m² or higher, or at least 27 kg/m² if you have at least one of these weight‑related health problems: high blood pressure (hypertension), high blood fats (dyslipidaemia), breathing stops during sleep (obstructive sleep apnoea), heart disease (cardiovascular disease), weak heart pumping (heart failure), kidney problems (chronic kidney disease), fatty liver disease linked to metabolism (metabolic dysfunction‑associated steatotic liver disease), knee joint wear (osteoarthritis of the knee), or difficulty controlling urine (stress urinary incontinence).
  • Your weight must have stayed fairly steady—no more than a 5 % change—in the three months before you are assigned to the study (the process called randomisation, which randomly places participants into the medication or placebo group).
  • You must have tried at least once on your own to lose weight and not succeeded.

Who cannot join the trial?

6 criteria

  • People whose obesity is mainly caused by other endocrine disorders (hormone‑related diseases) cannot join.
  • Anyone who has had Type 1 or Type 2 Diabetes Mellitus, whose blood sugar control measure HbA1c is ≥ 6.5% (or 48 mmol/mol), or who has taken medicines that lower blood sugar within the past 3 months is not eligible.
  • People with serious hepatobiliary disease (liver or bile‑duct problems) or who show any of the following lab results at screening are excluded:
    • ALT (a liver enzyme) level ≥ 3 times the normal upper limit.
    • AST (another liver enzyme) level ≥ 3 times the normal upper limit.
    • TBL (total bilirubin, a substance that indicates how well the liver works) > 1.5 times the normal upper limit, unless they have a known harmless condition called Gilbert’s Syndrome.
    • Anyone who has taken a GLP‑1 receptor agonist or any medication containing GLP‑1 (a type of drug that helps control weight and blood sugar) for any reason within 3 months before the study’s randomisation (the point when participants are assigned to treatment groups) cannot participate.
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Investigated drugs

AZD6234 is an investigational medication that contains the active substance lenbelintide. It is given as a liquid that you inject just under the skin. In this study, the drug is being tested to see if it can help people who are overweight or have obesity, along with at least one weight‑related health problem (but who do not have type 2 diabetes), lose weight over a period of about 68 weeks. Researchers are looking at how much body weight changes compared with a placebo, and they are also monitoring safety and any side effects.

What is already known about the treatment

AZD6234 (lenbelintide) - AZD6234 is supplied as a clear solution for injection and is administered under the skin (subcutaneously), usually once daily. It is still an investigational drug and is being studied in clinical trials, so it is not yet approved for general medical use. The medication is being tested to help people who are obese or overweight and have weight‑related health problems, but who do not have type 2 diabetes. Lenbelintide works by acting like a natural gut hormone that tells the brain to feel full, which reduces appetite and food intake, and it is classified as a peptide hormone analog used for weight management.

Investigated diseases

Obesity without type 2 diabetes - A condition characterized by excess body weight and body fat, typically identified by a body‑mass index of 30 kg/m² or higher. It often develops gradually as caloric intake consistently exceeds energy expenditure. Over time, the excess weight can increase waist circumference and may lead to higher levels of blood triglycerides and blood pressure. The condition can also cause changes in body composition, such as an increase in fat mass. As weight continues to rise, related metabolic disturbances may become more pronounced.
Trial detailsLast updated 11 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523379-41-00Protocol codeD8750C00014Estimated enrolment2 302 patientsSponsorAstraZeneca AB

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