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Study of once weekly subcutaneous zenagamtide versus placebo in adults with type 2 diabetes and chronic kidney disease on basal insulin

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What is this trial about?

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

People who have both type 2 diabetes and chronic kidney disease often need additional medicines to keep their blood sugar under control. In this study, participants continue using their usual once‑daily basal insulin, which may be taken alone or together with metformin, a medication that helps lower sugar, or with a class of drugs called SGLT2i that help the kidneys remove excess glucose. They are randomly given either the investigational medicine zenagamtide, which is injected under the skin once a week, or a placebo that looks the same but does not contain the active drug.

The purpose of the study is to determine whether zenagamtide can lower glycated haemoglobin (HbA1c) better than the placebo; this blood test reflects average sugar levels over the past two to three months. Participants receive the weekly injection for several months and attend regular clinic visits where safety checks and simple questionnaires are completed, without any invasive procedures.

Additional outcomes being observed include changes in body weight, the distance around the waist measured as waist circumference, levels of blood fats known as triglycerides, an inflammation marker called high-sensitivity C-reactive protein (hsCRP), a type of cholesterol measured as Non-high-density lipoprotein (Non-HDL) cholesterol, and the top number of blood pressure readings referred to as systolic blood pressure. Participants also track their sugar levels at seven different times during the day, which is described as 7-point self-measured plasma glucose (SMPG), to see how the treatment affects daily glucose patterns.

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

    Study Enrollment Confirmation

    After you agree to participate, the study team confirms your enrollment and provides you with a study identification number.

  2. Step 2

    Baseline Assessment

    You undergo baseline assessments, including blood tests to measure glycated hemoglobin (HbA1c), weight, waist circumference, blood pressure, and other laboratory values. These measurements establish your starting point before treatment begins.

  3. Step 3

    Randomization

    A computer program randomly assigns you to receive either zenagamtide or a placebo. Neither you nor the study staff know which product you receive.

  4. Step 4

    First Injection

    During the first visit you receive a subcutaneous injection of the assigned product using a pre‑filled pen. The injection is given under the skin, the dose is fixed according to the study protocol, and it is administered once each week.

  5. Step 5

    Weekly Injections

    You continue to give yourself (or have a healthcare professional give) a subcutaneous injection of the same product once every week for the entire study period. The injections are performed on the same day each week, and the dose does not change during the trial.

  6. Step 6

    Regular Follow‑up Visits

    Every four weeks you attend a clinic visit. At each visit you have blood drawn to check HbA1c, triglycerides, cholesterol, high‑sensitivity C‑reactive protein, and kidney function. Your weight, waist size, and blood pressure are also measured. Any side effects are reviewed, and the study staff may adjust other diabetes medicines if needed.

  7. Step 7

    Final Assessment

    At the end of the study you return for a final assessment, which repeats all baseline measurements. The data are used to compare the effect of zenagamtide with the placebo on blood‑sugar control, body weight, and other health indicators.

Who can join the trial?

7 criteria

  • Be male or female as assigned at birth.
  • Be at least 18 years old when you sign the consent form.
  • Have a diagnosis of type 2 diabetes that was made at least 180 days (about 6 months) before the screening visit.
  • Have a blood test called glycated haemoglobin (HbA1c) done at the screening laboratory (the exact level needed will be decided by the study team).
  • Take a stable once‑daily dose of basal insulin (at least 0.25 units per kilogram of body weight per day or 20 units per day) either by itself or together with metformin, a sodium‑glucose cotransporter‑2 inhibitor (SGLT2i), or both. The insulin dose must have stayed within ±20% of the same amount for the period before screening.
  • Have a documented history of chronic kidney disease according to your medical records or as judged by the doctor.
  • Be taking the highest approved or tolerated dose of an angiotensin‑converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless you cannot take them, and the dose must have been stable for at least 30 days before screening.

Who cannot join the trial?

11 criteria

  • Pregnant, breast‑feeding, planning pregnancy, or may become pregnant without adequate birth control: women who are currently pregnant, nursing a baby, intend to become pregnant, or could become pregnant and are not using reliable contraception cannot join the study.
  • Dialysis (chronic or intermittent hemodialysis or peritoneal dialysis): people who need regular treatments that clean the blood because the kidneys are not working well are excluded.
  • Combination use of an ACE inhibitor and an ARB within 30 days: taking two specific blood‑pressure medicines (an ACE inhibitor and an ARB) at the same time shortly before screening disqualifies a participant.
  • Use of diabetes or obesity medication not listed in the study: any diabetes or weight‑loss drug not allowed by the trial, except short‑term insulin for gestational diabetes or up to 14 consecutive days, makes a person ineligible.
  • Glucagon‑like‑peptide‑1 (GLP‑1) receptor agonists, dual GLP‑1/GIP receptor agonists, or amylin analogues: these are injectable diabetes medicines; using them before screening excludes a participant.
  • Diabetic retinopathy or maculopathy with recent eye treatment: individuals with diabetes‑related eye disease who had laser treatment, eye surgery (vitrectomy), or anti‑vascular endothelial growth factor injections within the past 180 days, or who are expected to need such treatment soon, cannot enroll. A recent eye exam is also required.
  • Recent heart attack, stroke, transient ischaemic attack (mini‑stroke), or hospitalization for unstable angina: anyone who experienced any of these heart or brain events within the last 60 days is excluded.
  • Severe chronic heart failure (New York Heart Association Class IV): the most advanced stage of heart failure, where symptoms occur at rest, makes a participant ineligible.
  • Planned coronary, carotid, or peripheral artery revascularisation: people who intend to have procedures to open blocked heart or blood vessels during the study period cannot take part.
  • Lupus nephritis or ANCA‑associated vasculitis: these are autoimmune diseases that affect the kidneys, and having them excludes a participant.
  • Kidney disease requiring immunosuppressive therapy: any primary or secondary kidney condition that needs drugs to suppress the immune system before screening disqualifies a person.
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Investigated drugs

  • zenagamtide B 10176

    is a medication that contains the active ingredient zenagamtide. It is provided as a liquid that can be injected under the skin using a pre‑filled pen. In the study it is given once a week to see if it can lower blood sugar levels (measured by HbA1c) in people with type 2 diabetes and chronic kidney disease who are already taking basal insulin, with or without metformin or an SGLT2 inhibitor.

  • NNC0487‑0111 B 10144

    is another formulation that also contains zenagamtide. Like the other product, it is a solution for subcutaneous injection in a pre‑filled pen and is administered once weekly. The trial tests whether this version can improve blood‑sugar control in the same group of participants.

  • NNC0487‑0111 B 10145

    is a test medication that delivers zenagamtide by injection under the skin. It comes in a ready‑to‑use pen and is taken once a week. Researchers are checking if it helps lower HbA1c in people with type 2 diabetes and kidney disease who are already on basal insulin.

  • NNC0487‑0111 B 10143

    is a subcutaneous injection of zenagamtide supplied as a liquid in a pre‑filled pen. Participants receive it once each week. The study aims to see whether it can improve blood‑sugar control for patients with type 2 diabetes and chronic kidney disease who are already using basal insulin.

  • NNC0487‑0111 B 10142

    is a weekly, under‑the‑skin injection of zenagamtide. It is provided as a solution in a pre‑filled pen, making it easy to use. The trial evaluates its ability to reduce HbA1c in people with type 2 diabetes and kidney disease who are on basal insulin therapy.

  • NNC0487‑0111 B 10141

    is a test product that contains zenagamtide and is administered by subcutaneous injection once a week using a pre‑filled pen. The purpose of the study is to determine if it can better control blood sugar in participants with type 2 diabetes and chronic kidney disease who are already on basal insulin.

What is already known about the treatment

Zenagamtide - It is given as a subcutaneous injection using a pre‑filled pen that contains a clear solution for injection. The drug is still experimental and is being studied in clinical trials; it is not yet approved for general medical use. Zenagamtide is being tested to lower blood sugar in people with type 2 diabetes and chronic kidney disease who are already using basal insulin, with or without metformin or SGLT‑2 inhibitors. It works by activating the body’s natural GLP‑1 receptors, which helps the pancreas release more insulin after meals and reduces the amount of glucose produced by the liver, and it is classified as a peptide GLP‑1 receptor agonist.

Investigated diseases

  • Type 2 diabetes mellitus

    A condition in which the body does not use insulin effectively, resulting in elevated blood sugar levels. It usually develops slowly and is associated with factors such as excess weight, physical inactivity, and family history. Over time, high blood sugar can affect many organs and systems. The disease can progress from mild glucose elevations to a stage where medication is required to maintain control. Without adequate management, it may lead to further health complications.

  • Chronic kidney disease

    A gradual decline in kidney function that occurs over months or years. The kidneys become less able to filter waste products and excess fluid from the blood. Early stages often have few or no symptoms, while later stages may cause swelling, fatigue, and changes in urine output. Common causes include diabetes, high blood pressure, and other kidney injuries. The condition can advance to a stage where kidney function is severely reduced.

Trial detailsLast updated 29 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525471-13-00Protocol codeNN9489-8034Estimated enrolment450 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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