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Efficacy and safety of zenagamtide versus semaglutide in adults with type 2 diabetes inadequately controlled on metformin and/or SGLT2 inhibitors

Investigational
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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 with type 2 diabetes whose blood sugar is not well controlled despite taking standard medicines such as metformin and a class called SGLT2i. Participants will be randomly assigned to receive weekly injections under the skin (subcutaneous) of either the experimental drug zenagamtide, the approved drug semaglutide, or a harmless placebo.

The main aim is to see whether the lower dose of zenagamtide works at least as well as the lower dose of semaglutide in lowering glycated haemoglobin A1c (HbA1c), a blood test that reflects average sugar levels over the past few months. The study will also look at changes in body weight, triglycerides (a type of fat in the blood), and waist circumference.

After enrollment, participants will receive an injection once a week for several months. Throughout the study they will visit the clinic for routine check‑ups where blood samples, weight and waist measurements are taken, and any side effects are recorded. The study ends after the planned treatment period, and the collected information is used to evaluate safety and effectiveness.

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

    Consent and Enrollment

    After joining the study you sign a consent form that explains the purpose of the research and your rights as a participant.

    Study staff confirm that you meet the required criteria, including having type 2 diabetes that is not fully controlled with metformin, SGLT2 inhibitors, or both.

  2. Step 2

    Baseline Assessments

    You undergo initial measurements that include a blood test for glycated haemoglobin A1c (HbA1c), which reflects average blood‑sugar levels over the past few months.

    Your body weight, waist size, and blood triglyceride levels are recorded, and your current diabetes medicines are reviewed.

  3. Step 3

    Randomization to Treatment Group

    You are randomly assigned to receive either zenagamtide, semaglutide, or a matching placebo that looks identical to the active injection.

    The assignment is kept confidential so that you and the study staff do not know which product you are receiving.

  4. Step 4

    Start of Study Medication

    You begin a subcutaneous injection, which means the medication is given under the skin using a pre‑filled pen.

    The injection is administered once weekly. The exact dose level is not specified in the provided information.

  5. Step 5

    Weekly Injections Throughout the Study

    You continue to give yourself the assigned injection every week for the duration of the trial.

    The study period runs from the estimated start date of 10 November 2026 to the estimated end date of 22 May 2028, so the weekly dosing continues for about 18 months.

  6. Step 6

    Periodic Clinic Visits

    At scheduled visits you meet study staff for safety checks and repeat the blood tests for HbA1c, body weight, waist circumference, and triglycerides.

    These visits allow the study team to monitor how the medication is affecting your diabetes and to ensure your well‑being.

  7. Step 7

    Final Study Visit and End of Treatment

    At the last visit, which occurs near the study’s end date, the same assessments performed at baseline are repeated.

    Your participation ends after this final evaluation, and you stop receiving the study medication.

Who can join the trial?

5 criteria

  • Must be male or female, regardless of gender identity.
  • Must be at least 18 years old when you sign the consent form.
  • Must have been diagnosed with type 2 diabetes (T2D) at least 180 days (about 6 months) before the screening visit.
  • Must be taking a steady daily amount of metformin (a common pill that helps lower blood sugar), a SGLT2 inhibitor (a medicine that helps the kidneys remove extra sugar in urine), or both, at a dose that works for you or the highest dose you can tolerate, for a set period before screening.
  • Must have a measured level of glycated haemoglobin (HbA1c) (a blood test that shows average blood sugar over the past 2‑3 months) within the required range, as checked by the study’s central laboratory at screening.

Who cannot join the trial?

8 criteria

  • Women who are pregnant, are breast‑feeding, plan to become pregnant, or could become pregnant and are not using an effective birth‑control method.
  • People who have had a heart attack, a stroke, a brief loss of blood flow to the brain (called a transient ischaemic attack), or a hospital stay for unstable chest pain (called unstable angina) within the last 60 days.
  • People with very severe chronic heart failure (called NYHA Class IV) at the time of screening.
  • People who are planning a procedure to open or repair blocked heart, neck (carotid), or leg arteries (called coronary, carotid, or peripheral artery revascularisation).
  • People who have a certain abnormal lab result (called CCI) measured by the central laboratory before screening.
  • People who are taking any diabetes or weight‑loss medicines that are not listed in the study plan, except short‑term insulin for gestational diabetes or for up to 14 days.
  • People who have used medicines that act like the hormone GLP‑1 (called GLP‑1 receptor agonists), medicines that combine GLP‑1 with another hormone called GIP, or medicines similar to amylin, before screening.
  • People with diabetic eye disease (called diabetic retinopathy or maculopathy) who had eye laser treatment, eye surgery (vitrectomy), or injections that block a growth factor (called anti‑VEGF) within the past 180 days, or who are likely to need such treatment in the next 180 days, and who have had an eye exam confirming the condition within the past 90 days.
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Investigated drugs

  • Semaglutide

    is a medication that is injected under the skin once a week. In this study it is used as the standard treatment (comparator) to see how well it lowers blood sugar in people with type 2 diabetes who are already taking metformin, an SGLT2 inhibitor, or both. The drug works by helping the pancreas release more insulin after meals and by reducing the amount of sugar the liver makes, which together help lower the overall blood‑sugar level.

  • Zenagamtide

    is an experimental drug that is also given as a weekly subcutaneous injection. In the trial it is the new treatment (test) being compared to semaglutide to find out if it can lower blood sugar just as well. Like semaglutide, it is intended to improve the body’s ability to control glucose, and the study will look at its safety and effectiveness in participants whose diabetes is not well‑controlled with their current medicines.

What is already known about the treatment

  • Semaglutide

    This medication is given as a subcutaneous injection using a pre‑filled pen that contains a clear solution. It is an approved drug that is widely used and described in many medical studies for treating type 2 diabetes. Semaglutide works by binding to the body’s GLP‑1 receptors, which helps the pancreas release more insulin after meals, lowers the release of the hormone glucagon, and slows stomach emptying, leading to lower blood sugar. It belongs to the class of GLP‑1 receptor agonist peptides.

  • Zenagamtide

    Zenagamtide is administered once a week by subcutaneous injection from a pre‑filled pen that holds a sterile solution. It is currently an investigational drug that is being studied in clinical trials and is not yet approved for routine medical use. The compound acts as a peptide that also activates GLP‑1 receptors, enhancing insulin secretion after meals and reducing glucose production, which helps control blood sugar levels. It is classified as an experimental GLP‑1 receptor agonist.

Investigated diseases

Type 2 diabetes - Type 2 diabetes is a chronic condition in which the body does not use insulin properly, leading to high blood sugar levels. Over time, the pancreas may produce less insulin, worsening the imbalance. Persistent high glucose can cause gradual changes in blood vessels and nerves. The disease often develops slowly, starting with mild elevation of sugar that may go unnoticed. Without management, blood sugar levels tend to rise further, increasing the burden on various organs.
Trial detailsLast updated 23 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525474-20-00Protocol codeNN9489-8449Estimated enrolment885 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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