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Study comparing cagrilintide and semaglutide versus tirzepatide in people with type 2 diabetes taking metformin or SGLT2 inhibitor

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study is looking at type 2 diabetes, a condition where the body does not properly control blood sugar levels. The study will test a combination medication called cagrilintide semaglutide, which contains two active substances that work together to help lower blood sugar and reduce body weight. This medication will be compared to another diabetes medicine called tirzepatide, which is available under the brand name Mounjaro. Both medications are given as injections under the skin once a week. The study will include people with type 2 diabetes who are already taking metformin, an SGLT2 inhibitor, or both of these medications, but whose blood sugar levels are not well controlled with these treatments alone.

The purpose of the study is to find out if cagrilintide semaglutide is at least as good as tirzepatide at lowering blood sugar levels, and whether it might be better at helping people lose weight. The study will also look at other health measures such as blood pressure, waist size, cholesterol levels, and overall quality of life. Additionally, the study will check how safe these medications are and what side effects people may experience while taking them.

People taking part in this study will receive either cagrilintide semaglutide or tirzepatide for 60 weeks. During this time, they will continue taking their current diabetes medications. Throughout the study, participants will have regular visits where their blood sugar levels, body weight, blood pressure, and other health measurements will be checked. Blood tests will be done to measure a substance called HbA1c, which shows average blood sugar levels over the past few months, as well as cholesterol and other blood fats. Participants will also be asked to complete questionnaires about their physical health and quality of life. The study team will monitor for any side effects, including episodes of low blood sugar, which can happen when blood sugar drops too much.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting treatment

    At the beginning of the trial (week 0), baseline measurements will be taken. These include HbA1c (a measure of average blood sugar levels over the past 2-3 months), body weight, blood pressure (both systolic and diastolic), waist circumference, and blood lipid levels (cholesterol and triglycerides).

    Quality of life questionnaires will also be completed at this point.

    The trial medication will be assigned. This will be either CagriSema (a combination of cagrilintide and semaglutide at 1.0 mg/1.0 mg) or tirzepatide (starting at 5 mg).

    All medications are administered as an injection under the skin (subcutaneous injection) once weekly.

    Current diabetes medication (metformin, SGLT2 inhibitor, or both) will be continued at the same stable dose throughout the trial.

  2. Step 2

    Treatment period

    The treatment period lasts 60 weeks in total.

    Throughout this period, weekly injections of the assigned medication will be self-administered under the skin.

    Regular monitoring visits will occur to assess blood sugar control, body weight, blood pressure, and other health parameters.

    Blood samples will be taken periodically to measure fasting plasma glucose (blood sugar level after not eating overnight) and other laboratory values.

    Any side effects or health changes will be recorded during scheduled visits.

  3. Step 3

    End of treatment assessment

    At week 60, the final treatment assessments will be performed.

    Measurements will include HbA1c, body weight, blood pressure, waist circumference, and blood lipid levels.

    Blood sugar targets will be evaluated, including whether HbA1c has reached levels of 6.5% or below, or below 7.0%.

    Weight loss will be assessed to determine if there has been a reduction of 5%, 10%, 15%, or 20% or more from the starting weight.

    Quality of life questionnaires will be completed again to compare with baseline scores.

    The number and type of any adverse events, including episodes of low blood sugar (hypoglycemia), will be reviewed.

Who can join the trial?

7 criteria

  • You can be male or female.
  • You must be 18 years old or older when you sign the consent form to join the study.
  • You must have been diagnosed with type 2 diabetes at least 180 days (about 6 months) before the screening visit. Type 2 diabetes is a condition where your body does not use insulin properly, causing high blood sugar levels.
  • Your HbA1c level must be between 7.0% and 10.5% at the screening visit. HbA1c is a blood test that shows your average blood sugar level over the past 2 to 3 months.
  • Your BMI must be 30 or higher at the screening visit. BMI stands for body mass index, which is a measure that uses your height and weight to estimate body fat.
  • You must have been taking a stable daily dose of diabetes medication for at least 90 days (about 3 months) before the screening visit. This medication must be either metformin, an SGLT2 inhibitor, or both. Metformin is a common diabetes medicine that helps lower blood sugar. SGLT2 inhibitors are medications that help your kidneys remove sugar from your body through urine.
  • The dose of your diabetes medication must be at an effective level or the maximum amount you can tolerate, as determined by your doctor.

Who cannot join the trial?

3 criteria

  • The study does not list specific exclusion criteria in the provided information, which means detailed reasons why patients cannot participate are not available in this document
  • Generally, clinical trials may exclude patients who do not meet certain health or medical requirements, but these specific details would need to be obtained from the complete study documentation
  • Patients should discuss with their doctor whether they are suitable candidates for this study based on their individual medical history and current health condition
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Investigated drugs

  • CagriSema

    is a combination medication that contains two medicines given together: cagrilintide and semaglutide. This treatment is given as an injection under the skin once a week. It is being tested to help people with type 2 diabetes better control their blood sugar levels and lose weight. The medication works by helping your body manage blood sugar and reducing appetite.

  • Tirzepatide

    is a medication given as an injection under the skin once a week. It is used to help people with type 2 diabetes control their blood sugar levels and can also help with weight loss. This medication works by helping your body release insulin when blood sugar is high and by reducing your appetite.

  • Metformin

    is a pill taken by mouth that is commonly used to treat type 2 diabetes. It helps lower blood sugar levels by reducing the amount of sugar your liver makes and helping your body use insulin better. Some people in this study may already be taking this medication before joining the trial.

  • SGLT2 inhibitor

    is a type of medication taken by mouth that helps lower blood sugar in people with type 2 diabetes. It works by helping your kidneys remove extra sugar from your body through urine. Some people in this study may already be taking this type of medication before joining the trial.

What is already known about the treatment

  • CagriSema

    CagriSema is an injectable medication given under the skin once a week that combines two active substances: cagrilintide and semaglutide. It is currently being studied in clinical trials for the treatment of type 2 diabetes in patients who are not achieving adequate blood sugar control with metformin, SGLT2 inhibitors, or both medications combined. The medication works through two complementary mechanisms: semaglutide mimics a natural hormone called GLP-1 that helps the body produce insulin and reduces appetite, while cagrilintide mimics another hormone called amylin that slows stomach emptying and helps control blood sugar levels after meals. This combination therapy aims to improve blood sugar control and promote weight loss in people with type 2 diabetes.

  • Tirzepatide

    Tirzepatide is an injectable medication administered under the skin once weekly that is approved and used for the treatment of type 2 diabetes in adults. It works by activating two important hormone receptors in the body: GIP and GLP-1 receptors, which help the pancreas release insulin when blood sugar is high, slow down digestion, and reduce appetite. This dual action helps lower blood sugar levels and promotes weight loss, making it effective for managing type 2 diabetes. In this clinical trial, tirzepatide 5 mg is being compared to CagriSema to evaluate which treatment is more effective at controlling blood sugar and reducing body weight.

Investigated diseases

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or does not produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can develop and persist in the bloodstream. The condition typically develops gradually, often beginning with a state called prediabetes where blood sugar levels are elevated but not yet high enough to be classified as diabetes. As the disease progresses, the body's ability to control blood sugar becomes increasingly impaired. This leads to elevated levels of a marker called HbA1c, which reflects average blood sugar levels over several months.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509600-15-00Protocol codeNN9388-7741Estimated enrolment1 000 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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