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A Study of Zenagamtide in Adults With Overweight or Obesity and Type 2 Diabetes

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What is this trial about?

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

This clinical trial is studying overweight or obesity and type 2 diabetes. The medicine being tested is NNC0487-0111, also called zenagamtide, given as a subcutaneous injection, which means an injection under the skin. The study is being done to see how well different doses of this medicine work and to check its safety compared with placebo.

People in the study receive one of several weekly dose levels of NNC0487-0111 or placebo. The treatment is given with a pre-filled pen and the study lasts for many months. During the study, body weight, blood sugar control, and other health changes are followed, along with any unwanted effects.

The study is designed to find out whether NNC0487-0111 can help reduce body weight in people who have excess body weight and type 2 diabetes. It also looks at changes in waist size, blood sugar, blood pressure, blood fats, and quality of life, as well as safety issues such as low blood sugar and other side effects.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study treatment begins</b>

    At the start of the trial, you receive zenagamtide or placebo as a subcutaneous injection, which means an injection under the skin.

    The study uses a pre-filled pen for the injection.

    The treatment is given once weekly.

    The study includes several zenagamtide dose groups: 00 mg, 00 mg, 00 mg, and 00 mg, each compared with placebo.

    The provided information does not state the exact treatment duration for each person.

  2. Step 2

    <b>during treatment visits</b>

    During the trial, you continue to receive the assigned injection once each week for the period defined by the study plan.

    Your body weight is checked so the study can measure the change in body weight.

    Your waist circumference is measured, which means the distance around your waist.

    Your body mass index (BMI) is measured, which is a number based on height and weight.

    Your blood pressure is measured, including systolic blood pressure (SBP), which is the top number, and diastolic blood pressure, which is the bottom number.

    Your haemoglobin A1c (HbA1c) is checked. This is a blood test that shows average blood sugar over the past few months.

    Your fasting plasma glucose (FPG) is checked. This is blood sugar measured after not eating for a period of time.

    Your fasting insulin is checked.

    Your urinary albumin-to-creatinine ratio (UACR) is checked. This is a urine test that can show how much protein is in the urine.

    Your lipids are checked. These include total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, non-HDL cholesterol, and triglycerides.

    Your high-sensitivity C-reactive protein (hsCRP) is checked. This is a blood test that can show inflammation in the body.

    Your quality of life is assessed using questionnaires, including the IWQOL-Lite-CT and the SF-36v2 acute survey. These ask about how weight affects daily physical function and well-being.

    The study monitors side effects, including serious side effects, side effects that lead to stopping treatment, and low blood sugar episodes.

    Low blood sugar is monitored as hypoglycaemia, which means blood sugar that is too low.

    A level 2 hypoglycaemic episode means blood sugar below 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose meter.

    A level 3 hypoglycaemic episode means severe low blood sugar with severe confusion or other serious brain symptoms that requires help from another person to recover.

  3. Step 3

    <b>end of study assessments</b>

    At the end of the trial period, the same measurements are used to check how the treatment affected your body weight, blood sugar, blood pressure, waist size, body mass index, urine protein, lipids, inflammation marker, and quality of life.

    The study then compares the results for people who received zenagamtide with the results for people who received placebo.

Who can join the trial?

9 criteria

  • Be an adult, meaning 18 years of age or older when signing the consent form.
  • Be male or female at birth.
  • Have a body mass index (BMI) that meets the study requirement. BMI is a number based on height and weight used to describe body size.
  • Have overweight or obesity and type 2 diabetes.
  • Have been diagnosed with type 2 diabetes mellitus at least 180 days before the screening visit. Screening is the set of tests and checks done before joining the study.
  • Be treated with lifestyle intervention, which means changes such as diet and exercise, and/or take 0 to 3 oral antidiabetic medicines approved in the local country.
  • If taking oral antidiabetic medicines, use only the allowed medicines, such as metformin, alpha-glucosidase inhibitors (medicines that slow sugar absorption from food), glinides, SGLT2 inhibitors (medicines that help remove sugar through the urine), thiazolidinediones, or sulfonylureas, either alone or in combination as allowed by the study.
  • Have been on the same oral antidiabetic medicine or medicines, with the same drug, same dose, and same dosing schedule, for at least the required stable period before screening.
  • Have an HbA1c level between 7% and 10% at screening. HbA1c is a blood test that shows the average blood sugar level over the past 2 to 3 months.

Who cannot join the trial?

6 criteria

  • Kidney function is too low, with an estimated glomerular filtration rate, or eGFR, below 30 mL/min/1.73 m² at screening. eGFR is a blood test estimate of how well the kidneys are filtering waste.
  • Has diabetic retinopathy or maculopathy that was treated with laser eye treatment (photocoagulation), vitrectomy (eye surgery to remove gel from inside the eye), or anti-VEGF medicine within the last 180 days before screening, or is expected to need such treatment within 180 days after screening.
  • The eye condition must have been checked by an eye examination within 90 days before screening, or between screening and randomisation. A dilated eye exam is required unless a special digital eye camera was used that does not need pupil dilation. Pupil dilation means using drops to widen the pupil.
  • Has known hypoglycaemic unawareness, meaning the person does not notice low blood sugar symptoms, as judged by the study doctor using a standard question.
  • Has had repeated severe low blood sugar episodes in the last year, as judged by the study doctor. Severe low blood sugar means an episode that is dangerous or needs help from another person.
  • Has used GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, any other GLP-1-based treatment, or amylin analogues within the required washout period before screening. A washout period is the time that must pass after stopping a medicine so it is no longer affecting the body.
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Investigated drugs

zenagamtide is the study medicine being tested in this trial. It is given as a shot under the skin using a pre-filled pen. The trial is looking at whether it helps people with overweight or obesity and type 2 diabetes lose body weight better than placebo, while also checking how safe it is.

What is already known about the treatment

Zenagamtide - Zenagamtide is given as a solution for injection in a pre-filled pen and is injected under the skin, usually once weekly in clinical studies. It is an experimental medicine and is still being studied in medical research, mainly for weight loss and for people who have overweight or obesity together with type 2 diabetes. It belongs to the group of medicines that act like gut hormones and works by attaching to a specific body signal system that helps reduce appetite, slow stomach emptying, and improve blood sugar control.

Investigated diseases

  • Overweight

    Overweight is a condition in which body weight is higher than what is considered healthy for a person’s height. It usually develops gradually when energy intake regularly exceeds energy use, leading to excess body fat. Over time, it can increase waist size and may be accompanied by changes in blood sugar, blood pressure, and blood fats.

  • Obesity

    Obesity is a condition marked by an unhealthy amount of body fat. It often develops slowly over time and can worsen as excess weight continues to build, especially when energy intake stays higher than energy use. It may be associated with increasing body mass index and waist circumference, along with changes in blood sugar, blood pressure, and blood fats.

  • Type 2 Diabetes Mellitus

    Type 2 diabetes mellitus is a long-term condition in which the body does not use insulin properly, causing blood sugar to rise. It usually develops gradually and may begin with mild changes in blood sugar before becoming more persistent. Over time, blood sugar control can worsen, and the condition may be linked with changes in weight, waist size, and blood pressure.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520441-23-00Protocol codeNN9490-8024Estimated enrolment675 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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