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A study testing cagrilintide for weight loss in people with overweight or obesity and type 2 diabetes

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 involves people who have overweight or obesity and also have type 2 diabetes, which is a condition where the body does not use insulin properly, leading to high blood sugar levels. The treatment being tested is cagrilintide, which is given as an injection under the skin once a week. Some people in the study will receive cagrilintide while others will receive placebo. The purpose of the study is to see if cagrilintide helps people lose more body weight compared to placebo when combined with lifestyle counseling about diet and physical activity.

During the study, participants will receive either cagrilintide at different dose levels or placebo for a treatment period of up to 64 weeks. All participants will also receive guidance on lifestyle changes to support weight management. The study will measure changes in body weight and track how many people achieve weight loss of at least 5%, 10%, or 15% of their starting weight. Other measurements will include changes in waist size, blood sugar control measured by HbA1c (a test that shows average blood sugar levels over time), blood pressure, and various blood fats such as cholesterol and triglycerides.

The study will also assess quality of life using questionnaires that ask about physical function and overall well-being, and will monitor any side effects or health problems that occur during treatment. Safety will be carefully tracked, including any episodes of low blood sugar, which can happen when blood sugar drops below normal levels. Participants may continue taking their usual diabetes medications during the study if they have been on a stable dose for a certain period before joining.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    After joining the study, you will be assigned to receive either cagrilintide or placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

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

    You will not know whether you are receiving cagrilintide or placebo during the study.

  2. Step 2

    Treatment administration

    You will receive injections once weekly throughout the treatment period.

    The injections will be given under the skin (subcutaneous route).

    If you are assigned to the active treatment group, you will receive cagrilintide at a specific dose determined by the study protocol.

  3. Step 3

    Lifestyle intervention counseling

    Throughout the study, you will receive lifestyle intervention counseling in addition to the medication.

    This counseling is designed to support weight management through guidance on diet and physical activity.

  4. Step 4

    Continuation of diabetes medications

    If you are currently taking medications for type 2 diabetes, you will continue taking them as prescribed during the study.

    Your diabetes treatment may include oral medications such as metformin or other antidiabetic drugs, and in some cases, insulin injections.

    The dose and frequency of your diabetes medications will remain stable throughout the study.

  5. Step 5

    Body weight monitoring

    Your body weight will be measured regularly throughout the study.

    The study will track changes in your weight to determine the effectiveness of the treatment.

    Measurements will also include your waist circumference.

  6. Step 6

    Blood sugar monitoring

    Your blood sugar levels will be monitored during the study.

    This includes measurements of fasting plasma glucose (blood sugar level after not eating overnight) and HbA1c (a measure of average blood sugar levels over the past 2 to 3 months).

    You will be monitored for episodes of hypoglycemia (low blood sugar), which can occur when blood sugar drops below normal levels.

  7. Step 7

    Blood pressure monitoring

    Your blood pressure will be measured at regular intervals during the study.

    Both the upper number (systolic) and lower number (diastolic) of your blood pressure will be recorded.

  8. Step 8

    Blood tests

    Blood samples will be collected to measure various substances in your blood.

    These tests will measure cholesterol levels (including total cholesterol, HDL or 'good' cholesterol, LDL or 'bad' cholesterol, and other types).

    Additional tests will measure triglycerides (a type of fat in the blood), insulin (a hormone that regulates blood sugar), and hsCRP (a marker of inflammation in the body).

  9. Step 9

    Quality of life assessments

    You will be asked to complete questionnaires about how your weight affects your quality of life.

    These questionnaires will assess your physical function and overall well-being.

    The assessments will help determine how the treatment affects your daily activities and general health.

  10. Step 10

    Safety monitoring

    Throughout the study, you will be monitored for any adverse events, which are unwanted or harmful effects that may occur during treatment.

    Any serious health problems that occur during the study will be recorded and evaluated.

    Special attention will be given to episodes of low blood sugar, particularly those requiring assistance from another person.

  11. Step 11

    Study completion

    The study is expected to continue until July 2027.

    You will attend regular study visits throughout the treatment period.

    Final assessments will be conducted at the end of your participation to evaluate the overall effects of the treatment.

Who can join the trial?

8 criteria

  • You must provide informed consent, which means you agree to participate in the study before any study procedures begin
  • You can be female or male
  • You must be 18 years of age or older
  • You must have tried at least one time in the past to lose weight through diet without success
  • Your body mass index must be 27.0 or higher. Body mass index is a number calculated from your weight and height that shows if you are overweight
  • You must have been diagnosed with type 2 diabetes at least 180 days before joining the study. Type 2 diabetes is a condition where your body does not use insulin properly, causing high blood sugar levels
  • You must be managing your diabetes through lifestyle changes alone, or taking 1 to 3 diabetes medications by mouth at the same dose for at least 90 days before joining the study. These medications may include metformin, alpha-glucosidase inhibitors, glinides, SGLT2 inhibitors, thiazolidinediones, DPP-4 inhibitors, or sulphonylureas
  • A small number of participants may also be taking GLP-1 medications at a stable dose for at least 1 year, or basal insulin at a minimum dose that has been stable for at least 90 days. Basal insulin is a long-acting insulin that helps control blood sugar throughout the day

Who cannot join the trial?

5 criteria

  • The study does not list specific exclusion criteria, which are conditions or situations that would prevent someone from joining the trial
  • However, based on the study design, you should not participate if you do not have overweight or obesity, meaning if your body weight is not above the healthy range for your height
  • You should not participate if you do not have type 2 diabetes, which is a condition where your body does not use insulin properly, causing high blood sugar levels
  • You cannot participate if you are outside the age range accepted for this study
  • You cannot participate if you are part of a vulnerable population that requires special protection in research studies
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Investigated drugs

  • Cagrilintide

    is an investigational medication given as an injection under the skin once a week. In this trial, it is being tested to help people with overweight or obesity and type 2 diabetes lose weight. It is used together with lifestyle changes such as diet and exercise counseling.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active medicine. It is used in the trial to compare how well cagrilintide works for weight loss.

What is already known about the treatment

Cagrilintide – Cagrilintide is an injectable medication given under the skin once a week that is being studied for weight management in people who are overweight or have obesity, particularly those with type 2 diabetes. This medication works by mimicking a natural hormone in the body called amylin, which helps control appetite and food intake by slowing down stomach emptying and sending signals to the brain that reduce hunger. It belongs to a class of drugs called amylin analogues, which are designed to help people lose weight when combined with lifestyle changes such as healthy eating and exercise. Currently, cagrilintide is in clinical trials to test whether it is safe and effective for helping people achieve significant weight loss compared to placebo treatment.

Investigated diseases

  • Overweight

    Overweight is a condition where a person has excess body weight compared to what is considered healthy for their height. This occurs when the amount of energy taken in through food and drinks exceeds the amount of energy used by the body over time. The extra energy is stored as fat tissue in various parts of the body. Overweight develops gradually as body weight increases above normal ranges. The condition can exist on its own or progress to obesity if weight gain continues. People with overweight may experience changes in their physical function and overall quality of life.

  • Obesity

    Obesity is a condition characterized by excessive accumulation of body fat that affects health and bodily functions. It develops when energy intake consistently exceeds energy expenditure over an extended period. As obesity progresses, fat deposits increase throughout the body, leading to changes in body composition and waist circumference. The condition often occurs alongside other health changes, including alterations in blood pressure, blood sugar levels, and blood fat levels. Obesity can affect physical function, mobility, and daily activities. The condition may also impact mental well-being and quality of life.

  • Type 2 Diabetes

    Type 2 diabetes is a condition where the body cannot properly use or produce enough insulin, leading to elevated blood sugar levels. The condition typically develops gradually over time as the body becomes less responsive to insulin. As the disease progresses, the pancreas may struggle to produce sufficient insulin to maintain normal blood glucose levels. This results in persistently high levels of sugar in the blood, which can be measured through fasting plasma glucose and glycated haemoglobin tests. People with type 2 diabetes may experience episodes of low blood sugar, especially when taking certain medications. The condition often occurs together with overweight or obesity and affects various aspects of metabolism.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519531-41-00Protocol codeNN9833-8243Estimated enrolment336 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).