Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Efficacy and safety of weekly subcutaneous zenagamtide versus placebo in adults with type 2 diabetes not controlled by diet and exercise

Investigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 levels are not well controlled by diet and exercise alone. Participants will receive a once‑weekly injection under the skin (subcutaneous) of the experimental drug zenagamtide or a matching placebo. The injection is delivered in a pre‑filled pen that looks similar for both groups.

The main goal is to determine whether the drug lowers average blood sugar, measured by glycated haemoglobin (HbA1c), better than the placebo. Secondary observations include changes in body weight, blood fats such as triglycerides and non‑HDL cholesterol, a blood marker of inflammation called hsCRP, results from an oral glucose tolerance test (OGTT) that checks how the body handles a sugary drink, patterns from self‑measured plasma glucose (SMPG) recordings taken at home throughout the day, and the top number of blood pressure readings, known as systolic blood pressure. Simple explanations are provided: HbA1c reflects average sugar levels over the past few months; triglycerides are a type of fat in the blood; non‑HDL cholesterol represents “bad” cholesterol; hsCRP indicates inflammation; OGTT measures sugar response after a drink; SMPG involves checking sugar several times a day; and systolic pressure is the first number in a blood pressure reading.

After an initial screening, participants are randomly assigned to receive either the study drug or the placebo each week for several months. Regular clinic visits are scheduled to give the injection, monitor safety, and collect blood samples, weight measurements, and blood pressure readings. The study finishes after the planned treatment period, and the collected data are analyzed to see if the drug provides a meaningful improvement over the placebo.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study Enrollment and Randomization

    You will attend an initial visit after joining the study. During this visit, study staff will confirm that you meet the criteria for type 2 diabetes and will assign you to receive either the test medication zenagamtide or a matching placebo. The assignment is done randomly, so you will not know which one you receive.

  2. Step 2

    Baseline Assessments

    Before starting the injections, you will undergo a series of measurements. These include a blood test to determine your glycated haemoglobin (HbA1c) level, body weight, triglyceride and cholesterol levels, a high‑sensitivity C‑reactive protein (hsCRP) test, and a blood pressure reading. You will also be asked to record your blood glucose at seven time points during a typical day.

  3. Step 3

    Weekly Subcutaneous Injection

    You will receive an injection under the skin (subcutaneous) using a pre‑filled pen. The injection contains either zenagamtide or placebo and is given once each week. The exact amount of the medication is not disclosed in the study documents, but the administration method and frequency are the same for all participants.

    You will continue to follow your usual diet and exercise plan throughout the trial.

  4. Step 4

    Regular Follow‑Up Visits

    At scheduled visits, you will repeat the same set of measurements that were done at baseline. These visits allow the study team to track changes in your HbA1c, body weight, blood lipids, hsCRP, blood pressure, and glucose patterns. The timing of these visits follows the study protocol and occurs throughout the trial period.

    If you are assigned the test medication, the weekly injections will continue until the final visit.

  5. Step 5

    End‑of‑Study Evaluation

    At the last visit, all measurements will be performed again to determine the overall effect of the treatment. After this visit, you will stop receiving study injections and will be returned to routine medical care.

Who can join the trial?

5 criteria

  • Be male or female, inclusive of all gender identities.
  • Be 18 years old or older when you sign the consent form.
  • Have been diagnosed with type 2 diabetes (a condition where the body does not use insulin properly) at least 30 days before the screening visit.
  • Never have taken any medication that lowers blood sugar, known as glucose‑lowering medication.
  • Have a blood test called glycated haemoglobin (HbA1c) done by the study’s central laboratory during the screening visit.

Who cannot join the trial?

9 criteria

  • Women who are pregnant, breastfeeding, planning to become pregnant, or could become pregnant and are not using reliable birth control. This means any woman who is currently pregnant, feeding a baby, intends to get pregnant, or could get pregnant without using effective contraception cannot join.
  • Anyone who is currently taking or has taken any diabetes medicines, including GLP‑1 receptor agonists, dual GLP‑1/GIP receptor agonists, or amylin analogues, for any reason. These are drugs that help control blood sugar. (Insulin used only for diabetes that occurs during pregnancy is allowed.)
  • Anyone who has used any medication for obesity before the screening visit. If you have taken a weight‑loss drug, you cannot participate.
  • People with diabetic eye disease (diabetic retinopathy or maculopathy) who have had recent eye treatments. This includes laser therapy, eye surgery called vitrectomy, or injections that block a protein named VEGF, performed within the last 180 days, or expected soon. You also need an eye exam within the past 90 days that includes pupil dilation unless a special non‑dilated camera is used.
  • Individuals whose blood test at the screening laboratory shows a specific abnormal result (the study calls this “CCI”). A certain lab value must not be present to join.
  • People who have had a heart attack, stroke, a brief temporary loss of brain blood flow (transient ischemic attack), or hospitalization for unstable chest pain (unstable angina) within the past 60 days. Recent serious heart or brain events exclude participation.
  • People with severe chronic heart failure classified as NYHA Class IV. This is the most advanced stage of heart failure where symptoms are present even at rest.
  • People who plan to have procedures to open blocked heart or blood vessels (coronary, carotid, or peripheral artery revascularisation). Planned surgeries to restore blood flow to the heart or other arteries prevent enrollment.
  • Individuals with the same specific abnormal lab result (“CCI”) identified by the central laboratory. A repeat of the lab‑based exclusion criterion.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

zenagamtide is an experimental injectable medicine that is given under the skin once a week. In this study it is being tested to see if it can lower blood‑sugar levels, measured by the HbA1c test, in people with type 2 diabetes who are not able to control their diabetes with diet and exercise alone. The drug is supplied as a liquid that comes pre‑filled in a pen‑type injector, making it easy for participants to give themselves the injection at home.

What is already known about the treatment

  • Placebo (Zenagamtide)

    This product is given as a subcutaneous injection using a pre‑filled pen, but it contains no active drug, only a harmless solution. It is not an approved medicine and is used solely as a control in clinical studies. The placebo helps researchers compare the effects of the real drug against a neutral treatment. It has no therapeutic indication, mechanism of action, or pharmacological class.

  • zenagamtide B 10176

    This medication is administered by subcutaneous injection with a pre‑filled pen, delivering a solution that contains the active peptide zenagamtide. It is currently an investigational drug, being studied in clinical trials and not yet approved for general medical use. Zenagamtide is intended for people with type 2 diabetes to lower blood sugar by activating the GLP‑1 receptor, which increases insulin release and reduces glucose production. It belongs to the class of GLP‑1 receptor agonist peptides.

  • NNC0487-0111 B 10143

    This product is injected under the skin using a pre‑filled pen that provides a solution of zenagamtide. It is an experimental therapy still in trial phases and has not received marketing approval. The drug works by mimicking a natural hormone that stimulates insulin release and slows down sugar production in the liver. It is classified as a GLP‑1 receptor agonist.

  • NNC0487-0111 B 10144

    Delivered as a subcutaneous injection from a pre‑filled pen, this formulation contains the peptide zenagamtide. It remains under investigation in clinical studies and is not yet an approved medication. Zenagamtide lowers blood glucose by binding to the GLP‑1 receptor, which enhances insulin secretion after meals. Its pharmacological class is GLP‑1 receptor agonist.

  • NNC0487-0111 B 10145

    This medication is given by subcutaneous injection using a pre‑filled pen that holds a zenagamtide solution. It is currently being tested in trials and has no regulatory approval at this time. The drug acts on the GLP‑1 receptor to increase insulin release and decrease liver glucose output, helping control diabetes. It falls under the GLP‑1 receptor agonist category.

  • NNC0487-0111 B 10146

    Administered as a subcutaneous injection from a pre‑filled pen, this product provides the active substance zenagamtide. It is an investigational agent, not yet authorized for routine clinical use. Zenagamtide works by activating the GLP‑1 receptor, which promotes insulin secretion and reduces blood sugar production. It is classified as a GLP‑1 receptor agonist.

Investigated diseases

Type 2 diabetes mellitus - Type 2 diabetes mellitus is a chronic condition in which the body does not use insulin properly, leading to high blood sugar. It usually develops gradually over years, often starting with mild elevation of glucose that may not cause symptoms. Over time, the pancreas produces less insulin, and blood sugar levels rise further. The condition can affect many organs, causing changes in how the body processes sugars and fats. Without proper control, the disease can progress from early insulin resistance to more pronounced hyperglycemia.
Trial detailsLast updated 28 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525470-18-00Protocol codeNN9489-8033Estimated enrolment150 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.