Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05567796

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fundación CESIM, Santa Rosa, La Pampa Province, Argentina

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 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion criteria

  • Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

semaglutide

Drug

Participants will recieve semaglutide subcutaneously.

Placebo Cagrilintide

Drug

Participants will receive placebo matched to cagrilintide.

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide.

Primary outcomes

  1. CagriSema versus placebo: Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%)

  2. CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants

Secondary outcomes

  1. CagriSema versus placebo: Achievement of >= 20% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participant

  2. CagriSema versus placebo: Achievement of >= 25% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participant

  3. CagriSema versus placebo: Achievement of >= 30% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participant

  4. CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%)

  5. CagriSema versus placebo: Relative change in body weight

    Time frame: From baseline (week 0) to week 8

    Measured as percentage (%)

  6. CagriSema versus placebo: Relative change in body weight

    Time frame: From baseline (week 0) to week 20

    Measured as percentage (%)

  7. CagriSema versus placebo: Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in centimeters (cm)

  8. CagriSema versus placebo: Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in millimeters of mercury (mmHg)

  9. CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  10. CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.

  11. CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in kilograms (kg)

  12. CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)

    Time frame: From baseline (week 0) to end of treatment (week 68)

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

  13. CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants. The categories are: BMI, underweight less than (<) 18.5, normal weight 18.5 to <25, overweight 25.0 to <30, obesity class I 30 to < 35, obesity class II 35 to < 40, obesity class III >40.

  14. CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%)

  15. CagriSema versus placebo: Change in HbA1c

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as millimoles per mole (mmol/mol).

  16. CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as millimoles per liter (mmol/L).

  17. CagriSema versus placebo: Change in FPG (mg/dL)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as milligrams per deciliter (mg/dL).

  18. CagriSema versus placebo: Ratio to baseline in fasting serum insulin

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  19. CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in mmHg

  20. CagriSema versus placebo: Ratio to baseline in total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  21. CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  22. CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  23. CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  24. CagriSema versus placebo: Ratio to baseline in Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  25. CagriSema versus placebo: Ratio to baseline in Free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  26. CagriSema versus semaglutide and cagrilintide: Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in centimeters (cm)

  27. CagriSema versus semaglutide and cagrilintide: Change in SBP

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in mmHg

  28. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  29. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  30. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  31. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  32. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  33. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  34. CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in kilograms (kg).

  35. CagriSema versus placebo: Relative change in body weight (Measured in percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%).

  36. CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in kilograms (kg).

  37. CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%).

  38. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as kilograms (kg)

  39. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%)

  40. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as kilograms (kg)

  41. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%)

  42. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%)

  43. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as %-points

  44. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as percentage (%).

  45. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as %-points

  46. CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in kilograms (kg)

  47. CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%)

  48. CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in kilograms (kg)

  49. CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured in percentage (%)

  50. CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  51. CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants. 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. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.

  52. CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  53. CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  54. CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  55. Change in Control of Eating (COEQ): Craving Control Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  56. Change in COEQ: Craving for Savoury food score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  57. Change in COEQ: Hunger score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  58. Change in COEQ: Craving for Sweets Score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  59. Change in COEQ: Positive Mood score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  60. Change in COEQ: Satiety score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    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), 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).

  61. CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

  62. CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as count of participants.

  63. CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP)

    Time frame: From baseline (week 0) to end of treatment (week 68)

    Measured as ratio

  64. Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study-main part (week 75)

    Measured as count of events

  65. Number of Treatment Emergent Serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study-main part (week 75)

    Measured as count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

Acronym: REDEFINE 1

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 5, 2022
Registry last updated
Jul 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.