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NCT Number: NCT06780449

A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female.
  • Age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to (>=) 35.0 kilograms per meter square (kg/m^2).

Exclusion criteria

  • Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes.

Treatment and study plan

Cagrilintide

Drug

Participants will receive cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Placebo Cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to week 104

    Measured in percentage (%).

Secondary outcomes

  1. Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  2. Number of participants who achieve >= 25 percent body weight reduction

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  3. Number of participants who achieve >= 30 percent body weight reduction

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  4. Change in waist circumference

    Time frame: From baseline (week 0) to week 104

    Measured in centimeter (cm).

  5. Change in waist to height ratio

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  6. Change in Systolic Blood Pressure (SBP)

    Time frame: From baseline (week 0) to week 104

    Measured in millimeter of mercury (mmHg).

  7. Ratio to Baseline in Lipids: Total Cholesterol

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  8. Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  9. Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  10. Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  11. Ratio to Baseline in Lipids: Triglycerides

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  12. Ratio to Baseline in Lipids: Free fatty acids

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  13. Ratio to Baseline in Lipids: Non-HDL cholesterol

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  14. Change in Body Mass Index (BMI)

    Time frame: From baseline (week 0) to week 104

    Measured in kilograms per meter square (kg/m^2).

  15. Number of participants who achieve BMI less than 30 kg/m^2

    Time frame: At week 104

    Measured as count of participants.

  16. Change in Glycated Haemoglobin (HbA1c) (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  17. Change in HbA1c (millimoles per mole [mmol/mol])

    Time frame: From baseline (week 0) to week 104

    Measured in mmol/mol.

  18. Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])

    Time frame: From baseline (week 0) to week 104

    Measured as mmol/L.

  19. Change in FPG (milligrams per deciliter [mg/dL])

    Time frame: From baseline (week 0) to week 104

    Measured as mg/dL.

  20. Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  21. Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  22. Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline

    Time frame: From baseline (week 0) to week 104

    Measured in days.

  23. Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline

    Time frame: From baseline (week 0) to week 104

    Measured in days.

  24. Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  25. Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  26. Time to T2D diagnosis as per ADA guideline

    Time frame: From baseline (week 0) to week 104

    Measured in days.

  27. Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score

    Time frame: From baseline (week 0) to week 104

    Measured in percentage of risk. American College of Cardiology/American Heart Association (ACC/AHA) risk estimator calculates 10 year risk of atherosclerotic cardiovascular disease (ASCVD) using a formula which includes age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure medication use, diabetes status, smoking status; minimum score 0, maximum score 100 where higher score indicates higher risk of 10-year risk of atherosclerotic cardiovascular disease (ASCVD).

  28. Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)

    Time frame: From baseline (week 0) to week 104

    Measured as count of participants.

  29. Ratio to baseline in C-reactive protein (CRP)

    Time frame: From baseline (week 0) to week 104

    Measured as ratio.

  30. Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])

    Time frame: From baseline (week 0) to week 104

    Measured in kg.

  31. Change in total fat mass by DXA relative to total body mass (kg)

    Time frame: From baseline (week 0) to week 104

    Measured in kg.

  32. Change in total fat mass by DXA absolute to total body mass (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  33. Change in total fat mass by DXA relative to total body mass (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  34. Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage.

  35. Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage.

  36. Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  37. Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  38. Change in lean body mass by DXA absolute to total body mass (kg)

    Time frame: From baseline (week 0) to week 104

    Measured in kg.

  39. Change in lean body mass by DXA relative to total body mass (kg)

    Time frame: From baseline (week 0) to week 104

    Measured in kg.

  40. Change in lean body mass by DXA absolute to total body mass (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  41. Change in lean body mass by DXA relative to total body mass (percentage points)

    Time frame: From baseline (week 0) to week 104

    Measured in percentage points.

  42. Change in Short Form (SF)-36 Physical functioning score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. The SF-36v2 acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. The scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical Functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.

  43. Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT): Physical Function Score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  44. Change in IWQOL-Lite-CT: Physical Score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  45. Change in IWQOL-Lite-CT: Psychosocial score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Psychosocial score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  46. Change in IWQOL-Lite-CT: Total score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Total score ranges from 0 to 100, with higher scores indicating better levels of functioning.

  47. Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. IWDAQ is an 18-item measure that uses an adaptive design to provide a personalised assessment of daily activity limitations associated with excess weight. At the baseline assessment the study participants choose the 3 activities (items) they would most like to improve the weight loss and rate the degree of limitation in each of these activities. At follow-up assessments, the study participants again rate the degree of current limitation in each of the same 3 activities. The measure yields the IWDAQ composite score with a score range from 3 to 15 with higher scores indicating greater personalised activity limitation.

  48. Change in Control of Eating questionnaire (CoEQ): Craving Control score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional patient reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving control subscale, the subscale score is reversed so that a higher score represents a greater level of craving control.

  49. Change in CoEQ: Positive Mood score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the Positive Mood subscale, item 6 'How anxious have you felt?' is reversed.

  50. Change in CoEQ: Craving for Sweets score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving sweets food subscale, higher score represents a greater level of craving.

  51. Change in CoEQ: Craving for Savoury score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the craving savoury food subscale, higher score represents a greater level of craving.

  52. Change in CoEQ: Hunger score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the hunger subscale, higher score represents a greater level of craving.

  53. Change in CoEQ: Satiety score

    Time frame: From baseline (week 0) to week 104

    Measured as score points. CoEQ is a 19-item multidimensional PRO that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10). For the satiety subscale, higher score represents a greater level of craving.

  54. CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to week 104

    Measured as count of events.

  55. CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From baseline (week 0) to week 104

    Measured as count of events.

  56. CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs

    Time frame: From week 104 to end of study (week 162)

    Measured as count of events.

  57. CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs

    Time frame: From week 104 to end of study (week 162)

    Measured as count of events.

  58. CagriSema 2.4 mg/2.4 mg: Number of TEAEs

    Time frame: From week 104 to end of study (week 162)

    Measured as count of events.

  59. CagriSema 2.4 mg/2.4 mg: Number of TESAEs

    Time frame: From week 104 to end of study (week 162)

    Measured as count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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