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A study testing how well cagrilintide and semaglutide help people with overweight or obesity lose weight

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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 obesity, which is a condition where a person has excess body weight that may affect their health. The treatment being tested is a combination medicine called cagrilintide semaglutide, which contains two active substances called cagrilintide and semaglutide. The medicine is given as a solution for injection under the skin once a week. Some people in the study will receive placebo instead of the active medicine. The study will test two different dose strengths of the combination medicine.

The purpose of the study is to see how well the combination medicine helps people with excess body weight lose weight compared to placebo, when used together with eating fewer calories and doing more physical activity. The study will look at how much body weight people lose and how many people achieve certain weight loss goals.

People taking part in the study will receive weekly injections under the skin for a treatment period that can last up to several weeks. During the study, different measurements will be taken to see how the treatment is working, including body weight, waist size, blood pressure, and various blood fat levels such as cholesterol and triglycerides. The study will compare the results between people who receive the active medicine and those who receive placebo.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment and medication start

    Upon joining the study, you will be assigned to one of the treatment groups. You may receive CagriSema (a combination of cagrilintide and semaglutide) at different dose levels, or a placebo (an inactive substance that looks like the medication but contains no active ingredients).

    The medication will be provided as a solution for injection that is administered under the skin (subcutaneous injection).

    The possible dose combinations are 1.0 mg/1.0 mg or 1.7 mg/1.7 mg of cagrilintide and semaglutide.

  2. Step 2

    Medication administration schedule

    You will administer the injection once weekly throughout the treatment period.

    The injection is given subcutaneously, which means the medication is injected into the fatty tissue just beneath the skin.

  3. Step 3

    Diet and physical activity modifications

    Throughout the study, you will need to follow a reduced-calorie diet as instructed.

    You will also be required to increase your physical activity level as part of the treatment plan.

    These lifestyle changes are an essential part of the study and work together with the medication.

  4. Step 4

    Body weight monitoring

    Your body weight will be measured regularly throughout the study to track changes from your starting weight.

    The study will assess whether you achieve specific weight reduction goals, including losing at least 5%, 10%, 15%, or 20% of your initial body weight.

  5. Step 5

    Additional health measurements

    Your waist circumference will be measured at regular intervals to track changes in body composition.

    Your blood pressure will be monitored, specifically the upper number (systolic blood pressure).

    Blood samples will be taken to measure various lipids (fats in the blood), including total cholesterol (overall fat levels), HDL cholesterol (often called good cholesterol), LDL cholesterol (often called bad cholesterol), VLDL cholesterol (another type of cholesterol), triglycerides (a type of fat), and free fatty acids (fats circulating in the blood).

  6. Step 6

    Study duration

    The study is expected to continue until approximately April 2026.

    You will continue with the weekly injections, dietary modifications, and physical activity changes throughout the entire study period, with regular monitoring visits as scheduled.

Who can join the trial?

5 criteria

  • You must have tried at least once before to lose weight by changing your diet, but it was not successful
  • You must be an adult, which means you are 18 years old or older
  • You must meet one of the following weight requirements:
    • Your BMI (body mass index, which is a calculation using your height and weight to measure body fat) is 30.0 or higher, or
    • Your BMI is 27.0 or higher and you also have at least one health problem related to excess weight, such as high blood pressure (when the force of blood against artery walls is too high), dyslipidaemia (abnormal levels of fats in the blood), obstructive sleep apnoea (a condition where breathing stops and starts during sleep), or cardiovascular disease (problems with the heart or blood vessels)
    • Both men and women can participate in this study

Who cannot join the trial?

3 criteria

  • The study information does not provide specific reasons why patients cannot participate in this trial
  • If you are considering joining this study about weight loss, you will need to discuss with the study team to learn about any health conditions or medications that might prevent you from participating
  • Generally, clinical trials have rules about who can join, but these specific details are not available in the current information
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Investigated drugs

  • Cagrilintide

    is a medication being tested in this trial to help with weight loss. It is given as an injection under the skin and works together with another medication to help reduce body weight when combined with a lower-calorie diet and more physical activity.

  • Semaglutide

    is a medication being tested in this trial to help with weight loss. It is given as an injection under the skin and works together with another medication to help reduce body weight when combined with a lower-calorie diet and more physical activity.

  • CagriSema

    is a combination medication that contains both cagrilintide and semaglutide together in one injection. It is given under the skin once a week to help people with overweight or obesity lose weight when they also follow a reduced-calorie diet and increase their physical activity.

What is already known about the treatment

CagriSema – CagriSema is an injectable medication given under the skin once weekly that combines two active substances: cagrilintide and semaglutide. This treatment is currently being studied in clinical trials for weight management in people with overweight or obesity, and it is designed to be used together with a reduced-calorie diet and increased physical activity. The medication works through two complementary mechanisms: semaglutide mimics a natural hormone called GLP-1 that helps control appetite and blood sugar levels, while cagrilintide is similar to another hormone called amylin that slows down stomach emptying and reduces food intake, together helping people eat less and lose weight. CagriSema belongs to the class of combination weight management medications that target multiple hormonal pathways involved in appetite regulation and metabolism.

Investigated diseases

Obesity – Obesity is a medical condition characterized by excessive accumulation of body fat in the body. It occurs when a person consistently consumes more calories than their body uses for energy over an extended period. The excess energy is stored as fat tissue, leading to increased body weight and elevated body mass index. This condition typically develops gradually as eating habits and physical activity levels remain imbalanced. Obesity affects multiple body systems and is associated with changes in waist circumference, blood pressure, and blood lipid levels including cholesterol and triglycerides. The condition can progress from mild overweight to more severe forms as body fat continues to accumulate.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509273-24-00Protocol codeNN9838-7749Estimated enrolment300 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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