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Study of cagrilintide for weight reduction in adults with overweight or obesity when combined with lifestyle changes

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What is this trial about?

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

This study focuses on people with obesity or overweight, which are medical conditions where a person carries excess body weight that may affect their health. The research evaluates a new medication called cagrilintide, which is given as an injection under the skin (subcutaneous injection) once weekly, along with lifestyle changes, to help with weight management.

The purpose of this research is to determine if cagrilintide is more effective than placebo in helping people lose weight. The study will specifically look at whether the medication can help people achieve a reduction of at least 5% of their body weight. During the study, participants will receive either cagrilintide or placebo injections for approximately 64 weeks.

The study will measure various health indicators including changes in body weight, waist size, blood pressure, and different types of cholesterol in the blood. It will also assess how the treatment affects quality of life and overall health. Throughout the study, participants' safety will be monitored by tracking any side effects that may occur.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your eligibility for the study will be evaluated based on your body mass index (BMI). You need to have either:

    - BMI of 30 or higher, or

    - BMI of 27 or higher with at least one weight-related health condition (such as high blood pressure, sleep apnea, or heart disease)

    You must be 18 years or older and have previously attempted to lose weight through diet

  2. Step 2

    Treatment period

    You will receive either cagrilintide or a placebo (substance with no active medication)

    The medication will be given as an injection under the skin (subcutaneous) once per week

    You will also receive guidance on lifestyle changes

    The study will continue until July 2027

  3. Step 3

    Measurements and monitoring

    Throughout the study, these aspects will be measured:

    - Your body weight and waist size

    - Blood pressure

    - Blood tests to check cholesterol, blood sugar, and other health markers

    - Quality of life assessment through questionnaires

    Any side effects or health changes will be recorded

  4. Step 4

    Treatment goals

    The main goals of the treatment are:

    - Reducing your body weight

    - Achieving at least 5% reduction in body weight

    Additional goals include possible 10% and 15% weight reduction and improvements in overall health measurements

Who can join the trial?

9 criteria

  • Must sign an informed consent form before any study activities begin
  • Can be male or female
  • Must be 18 years or older
  • Must have tried at least one diet to lose weight in the past without success
  • Must have either:
    • A Body Mass Index (BMI) of 30 or higher (BMI is a measure of body fat based on height and weight), or
    • A BMI of 27 or higher with at least one weight-related health condition, such as:
      • High blood pressure (hypertension)
      • Abnormal blood fat levels (dyslipidemia)
      • Sleep apnea (breathing pauses during sleep)
      • Heart and blood vessel problems (cardiovascular disease)

Who cannot join the trial?

15 criteria

  • Body Mass Index (BMI) below 27 kg/m² or above 50 kg/m²
  • Change in body weight greater than 5% within 90 days before screening
  • History of bariatric surgery (weight loss surgery) or planned bariatric surgery during the trial
  • Current treatment with prescription medications for weight management
  • History of type 1 diabetes (condition where body doesn't produce insulin)
  • Uncontrolled high blood pressure (above 160/100 mmHg)
  • History of heart attack or stroke in the past 6 months
  • History of pancreatitis (inflammation of the pancreas)
  • Current or history of eating disorders
  • Pregnant or breastfeeding women
  • Known allergies to the study medication or its components
  • Participation in another clinical trial within 90 days before screening
  • Severe kidney or liver problems
  • Current cancer treatment or history of cancer within past 5 years (except treated skin cancer)
  • History of substance abuse within the past 2 years
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Investigated drugs

Cagrilintide is a new medication being studied for weight management in people who are overweight or obese. It is given as an injection under the skin (subcutaneously) once per week. This medication is designed to work alongside lifestyle changes, including diet and exercise, to help people lose weight. It belongs to a new class of medications that aim to regulate appetite and metabolism to support weight reduction. Placebo is an inactive substance that contains no medication. In this trial, it is used as a comparison to measure how well cagrilintide works for weight management. Both treatments are given along with lifestyle intervention counseling, which includes guidance on diet and exercise to support weight loss efforts.

What is already known about the treatment

Cagrilintide - A novel injectable medication administered subcutaneously once weekly for weight management in people with overweight or obesity, used in conjunction with lifestyle interventions. This investigational drug belongs to the class of weight loss medications and works by modulating appetite signals in the brain, helping to reduce food intake and promote weight loss. Currently undergoing clinical trials to evaluate its efficacy and safety, cagrilintide represents a potential new treatment option in the growing field of obesity management, with preliminary studies focusing on its ability to achieve significant weight reduction of 5% or more from baseline weight.

Investigated diseases

  • Obesity

    A chronic medical condition characterized by excessive accumulation of body fat that can affect overall health. The condition develops when caloric intake consistently exceeds energy expenditure, leading to weight gain over time. Body fat accumulates throughout the body, particularly in the abdomen, under the skin, and around internal organs. Obesity is often accompanied by changes in metabolism and hormone function.

  • Overweight

    A condition where a person's body weight is higher than what is considered healthy for their height, but not as severe as obesity. The condition results from an energy imbalance where caloric intake exceeds the body's energy needs. Overweight can affect body composition and may lead to increased fat storage in various parts of the body. The condition can progress gradually over time as a result of lifestyle factors and metabolic changes.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519530-24-00Protocol codeNN9833-8242Estimated enrolment297 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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