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Study on How Cagrilintide and Semaglutide Help People with Overweight or Obesity Reduce Weight

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What is this trial about?

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

This clinical trial is focused on studying the effects of a new treatment called CagriSema for individuals who are experiencing overweight or obesity. The treatment involves a combination of two medications, cagrilintide and semaglutide, which are administered through a pen-injector device. The purpose of the study is to determine how well CagriSema helps in reducing body weight compared to a placebo, alongside a reduced-calorie diet and increased physical activity.

Participants in the study will receive a once-weekly injection of CagriSema or a placebo. The study will monitor changes in body weight, aiming for a reduction of at least 5% and potentially up to 30%. Other aspects being observed include changes in waist circumference, blood pressure, and quality of life related to weight. The study will also track any adverse events that may occur during the treatment period.

The trial is expected to continue until October 2026, with recruitment starting in November 2023. This research aims to provide valuable insights into the effectiveness and safety of CagriSema as a treatment option for managing overweight and obesity.

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

    Joining the study

    Upon joining the study, participants will be informed about the purpose and procedures of the trial. The study aims to evaluate the effectiveness and safety of a combination of medications called CagriSema for weight loss in individuals with excess body weight.

    Participants will be required to sign an informed consent form, confirming their understanding and willingness to participate in the study.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes checking age, body mass index (BMI), and any obesity-related health conditions.

    Eligibility criteria include being 18 years or older, having a BMI of 30 or higher, or a BMI of 27 or higher with at least one obesity-related complication such as high blood pressure or sleep apnea.

  3. Step 3

    Medication administration

    Participants will receive the study medication, CagriSema, which is a combination of two drugs administered via a subcutaneous injection (under the skin) once a week.

    The medication is intended to be used alongside a reduced-calorie diet and increased physical activity to aid in weight loss.

  4. Step 4

    Ongoing monitoring

    Throughout the study, participants will be regularly monitored to assess the effects of the medication on body weight and overall health.

    Regular check-ups will include measurements of body weight, waist circumference, and blood pressure, as well as assessments of quality of life and physical functioning.

  5. Step 5

    Completion of the study

    The study is expected to conclude by October 19, 2026. Participants will have a final assessment to evaluate the overall impact of the treatment.

    The primary goal is to observe a reduction in body weight, with secondary goals including improvements in waist circumference, blood pressure, and quality of life.

Who can join the trial?

7 criteria

  • Must be male or female.
  • Must be 18 years or older at the time of signing the consent form.
  • Must have a Body Mass Index (BMI) of 30.0 kg/m2 or higher. BMI is a measure of body fat based on height and weight.
  • If BMI is between 27.0 and 29.9 kg/m2, must have at least one obesity-related health issue, such as:
    • Hypertension (high blood pressure)
    • Dyslipidaemia (abnormal amount of fats in the blood)
    • Obstructive sleep apnoea (a sleep disorder where breathing repeatedly stops and starts)
    • Cardiovascular disease (heart and blood vessel conditions)

Who cannot join the trial?

9 criteria

  • Participants cannot join if they have a history of any serious heart problems.
  • Individuals with uncontrolled high blood pressure cannot participate.
  • People with a history of cancer in the last 5 years are excluded, except for some skin cancers.
  • Participants with any major psychiatric disorders, which are mental health conditions affecting mood, thinking, and behavior, are not allowed.
  • Those who have had surgery for weight loss in the past are not eligible.
  • Individuals with a history of drug or alcohol abuse in the last year cannot take part.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Participants who are currently involved in another clinical trial are excluded.
  • People with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.
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Investigated drugs

  • Cagrilintide

    is a medication that is being tested to help people lose weight. It is given as an injection under the skin. This medication works by making you feel full, so you eat less. It is being studied to see if it can help people who are overweight or have obesity to reduce their body weight when combined with a healthy diet and exercise.

  • Semaglutide

    is another medication used in this study, also given as an injection under the skin. It helps control appetite and can lead to weight loss. Like cagrilintide, it is being tested to see if it can help people with overweight or obesity lose weight when used together with a reduced-calorie diet and increased physical activity.

What is already known about the treatment

  • Cagrilintide

    Cagrilintide is administered as a subcutaneous injection, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in helping people with overweight or obesity lose weight. The medication works by mimicking a natural hormone in the body that helps regulate appetite, making you feel full sooner and reducing food intake. It is classified as a weight management medication and is being tested for its potential to enhance weight loss when combined with lifestyle changes like diet and exercise.

  • Semaglutide

    Semaglutide is also given as a subcutaneous injection, typically once a week. It is already used in medicine to help manage weight in people with obesity or overweight, and it is being further studied in combination with other treatments. Semaglutide acts by mimicking a hormone that increases insulin production and decreases appetite, helping to control blood sugar levels and reduce food intake. It belongs to a class of drugs known as GLP-1 receptor agonists, which are used for weight management and diabetes control.

Investigated diseases

Overweight and obesity – Overweight and obesity are conditions characterized by excessive body fat accumulation that may impair health. They develop when the energy intake from food and drink exceeds the energy expended through physical activity and metabolic processes. Over time, this energy imbalance leads to an increase in body weight and body fat. The progression of these conditions can result in increased body mass index (BMI), which is a measure of body fat based on height and weight. As body weight increases, individuals may experience changes in body shape and size, including increased waist circumference. These conditions can also affect physical function and quality of life, as they may lead to reduced mobility and increased strain on the body's systems.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506929-11-00Protocol codeNN9838-4608Estimated enrolment3 415 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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