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Study on the Long-term Weight Loss Effects of Cagrilintide and Semaglutide in Adults with Obesity

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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 treatment called CagriSema in people with obesity. Obesity is a condition where a person has an excessive amount of body fat, which can increase the risk of other health problems. The treatment being tested combines two substances, cagrilintide and semaglutide, which are given as a solution for injection. These substances are designed to help with weight loss when used alongside a reduced-calorie diet and increased physical activity.

The purpose of the study is to see if CagriSema is more effective than a placebo in helping people with obesity lose weight. Participants in the study will receive injections once a week using a special pen-injector device. The study will last for a period of time, during which participants will be monitored for changes in their body weight and other health indicators. The trial aims to confirm whether CagriSema can lead to significant weight loss and improvements in other health measures compared to those who receive a placebo.

Throughout the study, researchers will track various health outcomes, such as changes in waist size, blood pressure, cholesterol levels, and blood sugar levels. The study will also look at how the treatment affects participants' overall health and quality of life. The trial is expected to continue for several years to gather comprehensive data on the long-term effects and safety of the treatment. Participants will be closely monitored to ensure their safety and to assess the effectiveness of the treatment in promoting weight loss and improving health.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, gender, and body mass index (BMI) to ensure it is 35 kg/m² or higher.

  2. Step 2

    Medication administration

    Participants receive a combination of cagrilintide and semaglutide administered as a solution for injection under the skin (subcutaneous).

    The dosage is 2.4 mg of each medication, given once weekly.

  3. Step 3

    Diet and physical activity

    Participants are advised to follow a reduced-calorie diet and increase physical activity as part of the study requirements.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to track changes in body weight and other health indicators.

    Primary focus is on the relative change in body weight, with secondary measures including waist circumference, cholesterol levels, and blood sugar levels.

  5. Step 5

    Evaluation of outcomes

    The study aims to evaluate the effectiveness of the medication in achieving significant weight loss and improving other health parameters.

    Outcomes include achieving specific weight reduction targets and improvements in metabolic health markers.

  6. Step 6

    Completion of study

    The study is expected to conclude by November 17, 2028, with final assessments conducted to evaluate long-term effects.

Who can join the trial?

3 criteria

  • Participants can be either male or female.
  • Participants must be 18 years or older at the time they agree to join the study.
  • Participants must have a Body Mass Index (BMI) of 35.0 kg/m² or higher. BMI is a number calculated from a person's weight and height, and it helps to determine if someone is in a healthy weight range.

Who cannot join the trial?

4 criteria

  • Participants who are not willing to follow a reduced-calorie diet and increase physical activity.
  • Individuals who are not within the specified age range for the study.
  • People who are part of a vulnerable population, which means they might need special protection or care.
  • Participants who do not meet the health requirements set by the study.
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Investigated drugs

  • Cagrilintide

    is a medication being studied for its potential to help reduce body weight in people with obesity. It is given as an injection under the skin once a week. The goal is to see if it can help people lose weight when combined with a lower calorie diet and more physical activity.

  • Semaglutide

    is another medication used in this study, also given as an injection under the skin once a week. It is being tested in combination with cagrilintide to see if the two together can be more effective in helping people with obesity lose weight, alongside a reduced calorie diet and increased physical activity.

What is already known about the treatment

  • Cagrilintide

    This medication is administered via subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating obesity. It is not yet widely available in medical practice, as it is still under investigation. Cagrilintide works by mimicking a natural hormone that helps regulate appetite, leading to reduced food intake and weight loss. It is classified as an appetite suppressant.

  • Semaglutide

    This medication is also administered through subcutaneous injection and is being evaluated in combination with cagrilintide for the treatment of obesity. Semaglutide is already approved for use in managing type 2 diabetes and obesity, with ongoing research to explore its full potential. It functions by mimicking a hormone that increases insulin production and decreases appetite, aiding in weight loss. Semaglutide is classified as a GLP-1 receptor agonist.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this can result in increased body weight and changes in body composition, such as higher fat mass and altered fat distribution. Obesity can progress gradually, often starting with slight weight gain that becomes more significant if lifestyle factors remain unchanged. It is associated with various metabolic changes, including alterations in blood sugar levels, cholesterol, and blood pressure. The condition can also affect physical functioning and quality of life, influencing daily activities and overall well-being.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512144-39-00Protocol codeNN9838-7859Estimated enrolment400 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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