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Study comparing two forms of cagrilintide with placebo for weight loss in adults with overweight or obesity

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What is this trial about?

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

The study involves people who are overweight or have obesity. It tests two versions of an injectable medicine called cagrilintide that are given by subcutaneous injection (the medicine is placed just under the skin). A control group receives a placebo, which is a harmless injection without the active drug. All participants also receive advice on diet and physical activity counselling.

The aim is to see whether the new version of the medicine helps people lose weight at least as well as the existing version and better than the placebo. Participants receive an injection once a week for about six months, and their body weight is measured at the start and at the end of the treatment period.

During the study, researchers watch for any adverse events (side effects) and especially for serious adverse events (more serious health problems). After the six‑month treatment phase, participants are followed for a few more weeks to complete safety monitoring.

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

    Baseline assessment (week 0)

    You attend your first study visit on week 0. staff measure your weight and height, collect basic health information, and give you counseling about diet and physical activity. you are randomly assigned to receive either cagrilintide or placebo. both are clear solutions for injection that are given under the skin (subcutaneous injection). the exact amount of medication is set by the study protocol.

  2. Step 2

    Start of medication (weeks 1‑26)

    You receive a subcutaneous injection of the assigned product at regular intervals as explained by the study team. injections continue for 26 weeks. each injection is given in the abdomen or thigh according to the instructions. you keep following the diet and physical activity counseling throughout this period.

  3. Step 3

    Regular monitoring visits (throughout weeks 1‑26)

    You return to the clinic at scheduled times (often weekly or every few weeks) for weight measurement, safety checks, and to receive your next injection. any side effects are recorded, and counseling is reinforced.

  4. Step 4

    End of treatment visit (week 26)

    At week 26 you have a final weight measurement, complete the last injection if applicable, and receive a final counseling session. study medication stops after this visit.

  5. Step 5

    Safety follow‑up period (weeks 27‑33)

    After stopping the medication you attend follow‑up visits until week 33 to monitor for any adverse events. no further study medication is given.

  6. Step 6

    Final study visit (week 33)

    At week 33 you have a final safety assessment, answer any remaining questionnaires, and the study is considered complete for you.

Who can join the trial?

4 criteria

  • Informed consent must be signed before any study procedures are done.
  • You must be male or female (any gender identity).
  • You must be 18 years old or older when you sign the consent.
  • Your body mass index (BMI) must be 30 kg/m² or higher, or at least 27 kg/m² if you have at least one weight‑related health problem such as high blood pressure (hypertension), high blood fats (dyslipidaemia), obstructive sleep apnea, or heart or blood‑vessel disease (cardiovascular disease).

Who cannot join the trial?

3 criteria

  • Having a past diagnosis of type 1 diabetes (a condition where the body cannot produce insulin) or type 2 diabetes (a condition where the body does not use insulin properly).
  • Having taken any drug that contains or is similar to amylin (a hormone that helps control blood sugar and appetite), whether the drug is sold on the market or still experimental.
  • Currently using, or planning to start, any medication that is meant for weight loss or weight control within the last 180 days (about six months) before the screening visit.
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Investigated drugs

  • cagrilintide D

    is an experimental version of the weight‑loss drug cagrilintide that comes in a pre‑filled syringe for subcutaneous injection. In the trial it is being tested to see if it works as well as the standard formulation for helping people with overweight or obesity lose weight, while they also follow diet and exercise guidance.

  • cagrilintide

    is the standard formulation of the same weight‑loss medication, supplied as a solution for injection. It is used in the study as a comparator, allowing researchers to compare the new presentation with the established one, alongside diet and physical‑activity counseling.

What is already known about the treatment

  • cagrilintide D

    This medication is given as a subcutaneous injection using a pre‑filled syringe containing a clear solution for injection. It is an experimental drug that is currently being studied in late‑stage clinical trials for weight management in people who are overweight or have obesity. Cagrilintide D works by activating both the GLP‑1 and glucagon receptors, which helps reduce appetite and increase energy use. It belongs to the class of amylin analogs that act as dual‑agonist peptides.

  • cagrilintide

    This medication is also administered by subcutaneous injection, supplied as a standard solution for injection that must be drawn into a syringe. It is a well‑known investigational compound that has progressed through several clinical studies and is used as a comparator in weight‑loss research. Cagrilintide reduces food intake and boosts metabolism by stimulating GLP‑1 and glucagon receptors at the molecular level. It is classified as an amylin analog with dual agonist activity.

Investigated diseases

  • Overweight

    Overweight is a condition where a person carries more body weight than is considered healthy for their height. It usually develops gradually as excess calories are stored as fat, and the extra weight can increase over time if eating habits and activity levels do not change.

  • Obesity

    Obesity is a chronic condition marked by excessive accumulation of body fat that can affect health. It typically progresses from overweight as more fat builds up, often leading to further weight gain if lifestyle factors remain unchanged.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524249-29-00Protocol codeNN9833-8550Estimated enrolment285 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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