Weight loss in adults with obesity (with or without type 2 diabetes) using cagrilintide and semaglutide: a study of two dose levels versus semaglutide alone
The study focuses on adults who have obesity and may also have type 2 diabetes. Two treatments are being compared: a single medication called semaglutide given by injection once a week, and a new combination product that contains both cagrilintide and semaglutide, referred to as CagriSema, also given by injection once weekly at two different dose levels.
The aim is to determine whether the combination product leads to greater loss of body weight than semaglutide alone when participants also follow a reduced‑calorie diet and increase their physical activity. Participants will receive the assigned injection for several months, attend regular clinic visits to check weight, waist size, BMI, blood sugar levels, and any side effects, and will be asked to record their diet and exercise habits throughout the study.
1baseline assessment
after joining the study you will attend an initial visit where your weight, height, waist size, blood pressure, and blood samples are measured. these measurements establish a starting point for later comparisons.
the study staff will also review your medical history, current medicines, and any allergies to ensure the trial drugs are safe for you.
2receive study medication
you will be given a pre‑filled injection device containing either cagrilintide semaglutide (the test medication) or semaglutide (the comparator medication). the exact dose is assigned by the study and is described as 0 mg in the study documentation.
the medication is delivered by subcutaneous injection, which means it is placed under the skin using a small needle.
3start weekly injections
you will inject the medication once each week, on the same day of the week, as instructed. the injection is given under the skin of the abdomen or thigh.
continue the weekly injections for the entire treatment period defined by the study protocol.
4follow diet and activity plan
the study includes a reduced‑calorie diet plan that aims to lower your daily energy intake. you will receive written guidance on portion sizes and food choices.
you are also asked to increase physical activity, such as walking, cycling, or other moderate exercises, according to the schedule provided by the study team.
5regular follow‑up visits
you will return to the clinic at scheduled intervals (typically every 4 to 8 weeks) for safety checks and progress monitoring.
during each visit the staff will record your weight measurement, waist circumference, and may draw blood for tests such as cholesterol, glucose, and other safety labs.
6report side effects
if you experience any discomfort, unusual symptoms, or health changes, you should inform the study staff promptly. these are called adverse events and are recorded to evaluate the safety of the medication.
7final assessment
at the end of the treatment period you will attend a final visit where all measurements taken at baseline are repeated.
the final data will be used to determine changes in body weight, body‑mass index, and other health indicators compared with the start of the study.
Who Can Join the Study?
Anyone who was assigned male or female at birth, including all gender identities, can join.
You must be at least 18 years old when you sign the informed consent form.
Your Body Mass Index (BMI) must be 35 or higher. BMI is a number that compares your weight to your height to see if you are considered overweight.
If you do not have type 2 diabetes (T2D), you must have never been diagnosed with it and your glycated haemoglobin (HbA1c) level must be less than 6.5% (48 mmol/mol). HbA1c is a blood test that shows your average blood‑sugar level over the past three months.
If you have type 2 diabetes (T2D), you must have a known history of the condition and your glycated haemoglobin (HbA1c) level must be less than 10% (86 mmol/mol).
If you are screened and your HbA1c is 6.5% (48 mmol/mol) or higher, a doctor must confirm that you have type 2 diabetes before you can be randomly placed into a treatment group.
Who Cannot Join the Study?
A self‑reported change in your body weight of more than 5 % within the 90 days before screening prevents participation.
Use of any medication that is a glucagon‑like peptide‑1 receptor agonist (GLP‑1 RA)—drugs that help lower blood sugar and often aid weight loss—or any amylin analogue, which mimics a natural hormone that controls appetite, within the past 6 months prevents participation.
Semaglutide is a medication that is given as an injection under the skin. In this study it is used as the standard treatment (comparator) that participants receive once a week. The drug helps lower blood sugar and can also lead to weight loss, so it is being tested to see how well it works when added to a reduced‑calorie diet and more physical activity.
Cagrilintide semaglutide is a new combination therapy that contains both cagrilintide and semaglutide in a single injection given under the skin. In the trial this combination is the experimental treatment (test) and is being compared to semaglutide alone to see if adding cagrilintide improves weight loss and safety for people with obesity, with or without type 2 diabetes.
Obesity – A condition characterized by an excess amount of body fat that builds up over time, often because more calories are taken in than are used. The increase in fat can be gradual and may become noticeable as weight and waist size grow. As the condition progresses, it can make everyday activities feel more difficult and may affect a person’s comfort and mobility.
Type 2 diabetes mellitus – A metabolic disorder where the body does not respond properly to insulin, leading to higher levels of sugar in the blood. It usually develops slowly and is often associated with excess weight. Over time, the body may have trouble regulating blood sugar, causing frequent thirst, increased urination, and a feeling of low energy.
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