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Study of cagrilintide and semaglutide combination versus placebo in people with type 2 diabetes and painful diabetic peripheral neuropathy

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on people who have Type 2 diabetes and painful diabetic peripheral neuropathy, which is a type of nerve damage causing pain in people with diabetes. The purpose is to test if a combination medication called CagriSema (containing cagrilintide and semaglutide) works better than placebo in reducing nerve pain in these patients.

The medication being tested is given as a subcutaneous injection (an injection under the skin) once weekly. During the study, participants will receive either CagriSema or placebo. The study will measure how well the medication works by tracking changes in pain levels that participants experience.

Participants will use a special rating scale to record their pain levels throughout the study. The research will also look at other health measures such as blood sugar control, blood pressure, body weight, and various blood tests to understand how the medication affects the body. The safety of the medication will be monitored by tracking any side effects that may occur during the treatment.

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

    Initial assessment

    Your participation begins with measuring your body mass index (BMI), which must be 25.0 kg/m² or higher

    A blood test will check your HbA1c level (a measure of blood sugar control), which should be between 6.0% and 10.5%

    You will need to confirm having type 2 diabetes diagnosis for at least 180 days

  2. Step 2

    Pain assessment period

    You will need to document your nerve pain daily using an electronic diary for 2 weeks

    The diary needs to be completed at least 4 out of 7 days each week

    Your current pain medication should have been stable for at least 3 months

  3. Step 3

    Treatment phase

    You will receive either CagriSema (combination of cagrilintide and semaglutide) or placebo

    The medication will be given as an injection under the skin once weekly

    You will continue your current diabetes medications as prescribed

  4. Step 4

    Monitoring period

    Regular measurements will track your pain levels using a numerical scale

    Your blood pressure, blood sugar, and body weight will be monitored

    Blood tests will check cholesterol levels and other health markers

    Any side effects or severe low blood sugar episodes will be recorded

  5. Step 5

    Sleep and quality of life assessment

    Your sleep quality will be evaluated using a special questionnaire

    The impact of pain on your daily activities will be assessed

    Changes in nerve symptoms will be monitored through specific tests

Who can join the trial?

9 criteria

  • Must be male or female aged 18 years or older
  • Must have a body mass index (BMI) of 25.0 kg/m2 or higher (BMI is a measure of body fat based on height and weight)
  • Must have been diagnosed with type 2 diabetes for at least 180 days (6 months) before screening
  • Must be on stable doses of diabetes medications for at least 90 days, which may include:
    • Oral diabetes medications (pills taken by mouth)
    • Insulin injections
    • Must have a HbA1c level between 6.0% and 10.5% (HbA1c is a blood test that measures average blood sugar levels over the past 3 months)
    • Must have painful diabetic peripheral neuropathy (nerve pain in hands or feet due to diabetes) for at least 3 months before screening
    • Must complete daily pain diary entries for at least 4 out of 7 days during the two-week screening period
    • Must be on a stable pain treatment plan (medications or other treatments) for at least 3 months before screening

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions to any medications similar to those used in the study
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials or within the past 30 days
  • History of chronic alcohol abuse or drug addiction within the past 12 months
  • Major surgery within the past 3 months or planned during the study period
  • Severe kidney disease (problems with kidney function)
  • Severe liver disease (problems with liver function)
  • History of pancreatic inflammation (pancreatitis)
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of heart attack or stroke within the past 6 months
  • Any other medical condition that could interfere with the study treatment or make participation unsafe
  • Unable to perform self-injection of medication
  • Mental conditions that could affect ability to follow study procedures
  • History of thyroid cancer or certain other types of cancer
  • Taking medications that could interfere with the study treatment
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Investigated drugs

  • Cagrilintide

    is a medication being studied for treating people with type 2 diabetes who also experience painful diabetic nerve damage. It is designed to be given as an injection under the skin once per week.

  • Semaglutide

    is a medication used to treat type 2 diabetes. It helps control blood sugar levels and is given as an injection under the skin once per week. It belongs to a class of medications called GLP-1 receptor agonists, which help the body produce more insulin when blood sugar levels are high.

  • CagriSema

    is a combination therapy that contains both cagrilintide and semaglutide in a single treatment. It is being studied as a weekly injection for people who have type 2 diabetes and painful diabetic nerve damage (diabetic peripheral neuropathy).

What is already known about the treatment

  • Semaglutide

    A once-weekly injectable medication that belongs to the GLP-1 receptor agonist class, used in the treatment of type 2 diabetes and painful diabetic peripheral neuropathy. This medication works by mimicking the effects of the natural hormone GLP-1, helping to regulate blood sugar levels by stimulating insulin production and reducing glucagon secretion when blood sugar is high. It is administered via subcutaneous injection and has shown significant effectiveness in both glycemic control and potential neuropathic pain management in clinical trials.

  • Cagrilintide

    An investigational injectable medication being studied in combination with semaglutide for the treatment of type 2 diabetes and painful diabetic peripheral neuropathy. This novel drug is administered subcutaneously once weekly and is being evaluated for its potential synergistic effects when combined with semaglutide. The medication works through a unique mechanism that, when combined with semaglutide, may offer enhanced therapeutic benefits for patients with diabetic complications.

Investigated diseases

  • Type 2 diabetes

    A chronic metabolic disorder where the body becomes resistant to insulin or doesn't produce enough insulin to maintain normal blood sugar levels. The condition develops gradually, usually in adults, causing high blood sugar levels that can damage various body systems over time. The body either resists the effects of insulin or doesn't produce sufficient insulin to maintain normal glucose levels.

  • Diabetic peripheral neuropathy

    A nerve disorder that occurs as a complication of diabetes, causing damage to the nerves in the extremities, particularly the feet and legs. It typically begins with numbness, tingling, or burning sensations in the affected areas and can progress to cause varying degrees of pain. The condition develops gradually and can affect both sensory and motor nerves in the peripheral nervous system.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509662-38-00Protocol codeNN9388-7864Estimated enrolment142 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).