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Zenagamtide Compared with Semaglutide 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 type 2 diabetes in people with overweight or obesity. It compares a new medicine called NNC0487-0111, also known as zenagamtide, with semaglutide, which is already used for weight management and diabetes care. The purpose of the study is to see whether NNC0487-0111 helps lower body weight better than semaglutide and to learn more about its safety.

Both medicines are given as a subcutaneous injection, which means an injection under the skin, once a week. People in the study receive one of several dose plans of NNC0487-0111 or semaglutide, and some study groups receive placebo. The study follows changes in body weight, blood sugar, waist size, blood pressure, and other health measures over time. It also looks at side effects, including low blood sugar, which can happen when blood sugar drops too far.

The study is planned to run for a long period, with treatment and follow-up visits spread across the study time. The medicines are given in a pre-filled pen, and the course of the study is designed to compare how the different treatments work and how safe they are in adults with excess body weight and type 2 diabetes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the trial

    You enter the study as a participant with overweight or obesity and type 2 diabetes.

    The study compares NNC0487-0111 with semaglutide to see how well each medicine helps reduce body weight.

  2. Step 2

    Study treatment period

    You receive one of the study medicines as a subcutaneous injection, which means an injection given under the skin, once weekly.

    The test medicine is NNC0487-0111, given in a pre-filled pen. The listed study products are NNC0487-0111 B 10141, NNC0487-0111 B 10142, NNC0487-0111 B 10143, NNC0487-0111 B 10144, NNC0487-0111 B 10145, and NNC0487-0111 B 10146.

    The comparison medicine is semaglutide, given in a pre-filled pen. The listed study products are Wegovy 0.25 mg, Wegovy 0.5 mg, Wegovy 1 mg, Wegovy 1.7 mg, and Wegovy 2.4 mg.

    A placebo may also be used. A placebo is a study treatment with no active medicine. The listed placebo products are Placebo Semaglutide and Placebo NNC0487 0111 B.

    The source data do not give the exact dose, dose changes, or length of treatment for each product. The only dosing detail given is that the injection is once weekly.

  3. Step 3

    Measurement of body weight and other study outcomes

    Your body weight is measured to see the main effect of the study medicine.

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

    Your waist circumference is measured. This is the size around your waist.

    Your blood pressure is measured, including systolic blood pressure (SBP) and diastolic blood pressure (DBP). Systolic blood pressure is the top number in a blood pressure reading, and diastolic blood pressure is the bottom number.

    Your blood is checked for hemoglobin A1c (HbA1c), which shows average blood sugar over time.

    Your blood is checked for fasting plasma glucose (FPG), which is blood sugar after not eating.

    Your blood is checked for fasting insulin.

    Your urine is checked for urinary albumin-to-creatinine ratio (UACR), which is a urine test used to look for kidney-related changes.

    Your blood is checked for lipids, including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, non-HDL cholesterol, and triglycerides. Lipids are fats in the blood.

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

  4. Step 4

    Safety monitoring during the trial

    You are monitored for treatment-emergent adverse events (TEAEs), which are unwanted medical problems that appear after treatment starts.

    You are monitored for treatment-emergent serious adverse events (TESAEs), which are serious unwanted medical problems that appear after treatment starts.

    You are monitored for any adverse events that lead to permanent treatment discontinuation, meaning the study medicine is stopped and not restarted.

    You are monitored for hypoglycaemic episodes, which are low blood sugar events.

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

    A severe hypoglycaemic episode (level 3) means low blood sugar is linked with severe trouble thinking clearly and needs help from another person to recover, with no specific blood sugar number required.

  5. Step 5

    Extension phase

    If you continue into the extension phase, your body weight and body mass index (BMI) are measured again.

    During this phase, you are also monitored again for TEAEs, TESAEs, adverse events leading to permanent treatment discontinuation, clinically significant hypoglycaemic episodes, and severe hypoglycaemic episodes.

    The source data do not give the exact duration of the extension phase.

  6. Step 6

    End of the trial

    The study ends after the planned trial period is completed.

    The source data list the estimated study period from 2026-05-20 to 2028-12-29.

Who can join the trial?

8 criteria

  • Adults who are 18 years of age or older when they sign the consent form.
  • Both men and women can take part.
  • A body mass index (BMI) at screening that is at least the required study value. BMI is a measure of body weight compared with height.
  • Have type 2 diabetes that was diagnosed at least 180 days before screening.
  • Have a hemoglobin A1c (HbA1c) result between 7% and 10% at screening. HbA1c is a blood test that shows average blood sugar over the past 2 to 3 months.
  • Have been treated with lifestyle changes and/or up to 3 oral diabetes medicines before screening. Lifestyle changes means changes in eating, physical activity, and weight management.
  • If using oral diabetes medicines, the treatment must have been stable before screening. Stable means the same medicine or medicines, the same dose, and the same number of times taken each day for the required time before screening.
  • The oral diabetes medicines allowed include metformin, alpha-glucosidase inhibitors (medicines that help slow sugar absorption from food), glinides, SGLT2 inhibitors (sodium-glucose cotransporter 2 inhibitors, medicines that help the kidneys remove sugar in urine), thiazolidinediones, and sulfonylureas.

Who cannot join the trial?

7 criteria

  • Kidney function too low: if the estimated glomerular filtration rate, or eGFR (a test that shows how well the kidneys filter blood), is below 30 mL/min/1.73 m² at screening.
  • Eye disease with recent or expected treatment: if the participant has diabetic retinopathy or maculopathy (eye damage caused by diabetes that can affect vision) and has had treatment with retinal photocoagulation (laser treatment for the retina), vitrectomy (surgery to remove gel from the eye), or anti-VEGF treatment (medicine that blocks abnormal blood vessel growth) within 180 days before screening, or is expected to need such treatment within 180 days after screening.
  • Eye condition not properly checked: if diabetic retinopathy or maculopathy has not been confirmed with an eye examination done within 90 days before screening or between screening and randomization.
  • Pupil dilation needed for the eye exam: the eye examination must usually include pupil dilation (drops that widen the pupil) unless a special digital camera is used that does not require dilation.
  • Not able to sense low blood sugar: if the participant has hypoglycaemic unawareness, meaning they do not notice the warning signs of low blood sugar, as judged by the investigator using a questionnaire.
  • Repeated severe low blood sugar: if the participant has had recurrent severe hypoglycaemic episodes (more than one serious low blood sugar event) during the last year, as judged by the investigator.
  • Recent use of certain diabetes medicines: if the participant 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 no longer affects the study.
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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 once a week using a pre-filled pen. The trial is checking how well it helps with weight loss and whether it is safe for people with overweight or obesity and type 2 diabetes.

  • semaglutide

    is the comparison medicine in this trial. It is also given as a shot under the skin once a week using a pre-filled pen. The study uses it to see how the new study medicine works compared with a medicine already used for weight management and diabetes-related care.

What is already known about the treatment

  • Semaglutide

    Semaglutide is given as a solution for injection under the skin, usually once weekly, using a pre-filled pen. It is an approved and well-studied medicine in medical literature, mainly used to help with type 2 diabetes and to support weight loss in people with overweight or obesity. It works by copying a natural body signal called GLP-1, which helps the pancreas release insulin when blood sugar is high, lowers appetite, and slows how fast food leaves the stomach. Semaglutide is classified as a GLP-1 receptor agonist and belongs to the medicines used for diabetes and weight management.

  • Zenagamtide

    Zenagamtide is given as a solution for injection under the skin, usually once weekly, using a pre-filled pen. It is an investigational medicine, which means it is still being studied in clinical trials and is not yet widely approved for routine medical use. It is being tested for people with overweight or obesity and type 2 diabetes, with the aim of helping lower body weight and improve blood sugar control. Zenagamtide is a GLP-1 receptor agonist, and it works by activating the same body receptor as natural GLP-1, which can increase insulin release when needed, reduce hunger, and slow digestion.

Investigated diseases

Obesity - A long-term condition in which excess body fat builds up to a level that can affect health. It usually develops gradually when energy intake regularly exceeds energy use, leading to increasing body weight over time. The condition can remain stable, or body weight may continue to rise if the imbalance persists.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520446-31-00Protocol codeNN9490-8028Estimated enrolment1 000 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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