REDEFINE 1: A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy range

Protocol Title: Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity - Redefine1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005435-75-FI

Enrollment

3400

Registered

2022-06-16

Start date

2022-08-30

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 24.1 Level: PT Classification code 10033307 Term: Overweight System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: Cagrilintide B 1.0 mg/mL + semaglutide I 0.5 mg/mL DV3384 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: semaglutide CAS Number: 910463-68-2 Other des

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female - Age above or equal to 18 years at the time of signing informed consent - a) BMI greater than or equal to 30.0 kg/m^2 or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3128 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 272

Exclusion criteria

Exclusion criteria: Glycaemia related: -HbA1c greater than or equal to 6.5 % (48 mmol/mol) as measured by the central laboratory at screening -History of type 1 or type 2 diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet and increased physical activity in participants with overweight or obesity.;Secondary Objective: -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 20% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 25% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 30% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on body weight -To confirm superiority of CagriSema 0.5 mg/0.5 mg versus placebo on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on: •Waist circumference •Systolic blood pressure •Physical functioning -To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg;Primary end point(s): 1. Relative change in body weight 2. Achievement equal to or greater than 5% weight reduction;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 68)	—

Measure

Time frame

Main Objective: To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus placebo as adjuncts to reduced-calorie diet and increased physical activity in participants with overweight or obesity.;Secondary Objective: -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 20% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 25% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on achievement equal to or greater than 30% weight reduction -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on body weight -To confirm superiority of CagriSema 0.5 mg/0.5 mg versus placebo on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on body weight -To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo on: •Waist circumference •Systolic blood pressure •Physical functioning -To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg versus placebo, semaglutide 2.4 mg and cagrilintide 2.4 mg;Primary end point(s): 1. Relative change in body weight 2. Achievement equal to or greater than 5% weight reduction;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 68)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Achievement of = 20% weight reduction 2. Achievement of = 25% weight reduction 3. Achievement of = 30% weight reduction 4. Relative change in body weight 5. Relative change in body weight 6. Relative change in body weight 7. Change in waist circumference 8. Change in systolic blood pressure (SBP) 9. Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score 10. Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score 11. Change in body weight 12. Change in body mass index (BMI) 13. Improvement in weight category (BMI, underweight 40) 14. Change in Glycated Haemoglobin (HbA1c) 15. Change in Fasting Plasma Glucose (FPG) 16. Ratio to baseline in fasting serum insulin 17. Change in Diastolic Blood Pressure (DBP) 18. Ratio to baseline in lipids: • Total cholesterol • High-density lipoprotein (HDL) cholesterol • Low-density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids 19. Change in waist circumference 20. Change in SBP 21. Ratio to baseline in lipids: • Total cholesterol • HDL • LDL • VLDL • Triglycerides • Free fatty acids 22. Relative and absolute change in body weight 23. Change in total fat mass by Dual energy X-ray absorption (DXA) absolute and relative to total body mass 24. Change in visceral fat mass by DXA, relative to baseline and relative to total amount of fat mass in visceral fat mass region 25. Change in lean body mass by DXA absolute and relative to total body mass 26. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score 27. Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score 28. Change in IWQOL-Lite-CT: • Physical Function • Psychosocial • Total score 29. Change in Control of Eating (CoEQ): • Craving Control score • Positive Mood score • Craving for Sweets score • Craving for Savoury food score • Hunger	—

Measure

Time frame

Secondary end point(s): 1. Achievement of = 20% weight reduction 2. Achievement of = 25% weight reduction 3. Achievement of = 30% weight reduction 4. Relative change in body weight 5. Relative change in body weight 6. Relative change in body weight 7. Change in waist circumference 8. Change in systolic blood pressure (SBP) 9. Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score 10. Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score 11. Change in body weight 12. Change in body mass index (BMI) 13. Improvement in weight category (BMI, underweight 40) 14. Change in Glycated Haemoglobin (HbA1c) 15. Change in Fasting Plasma Glucose (FPG) 16. Ratio to baseline in fasting serum insulin 17. Change in Diastolic Blood Pressure (DBP) 18. Ratio to baseline in lipids: • Total cholesterol • High-density lipoprotein (HDL) cholesterol • Low-density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids 19. Change in waist circumference 20. Change in SBP 21. Ratio to baseline in lipids: • Total cholesterol • HDL • LDL • VLDL • Triglycerides • Free fatty acids 22. Relative and absolute change in body weight 23. Change in total fat mass by Dual energy X-ray absorption (DXA) absolute and relative to total body mass 24. Change in visceral fat mass by DXA, relative to baseline and relative to total amount of fat mass in visceral fat mass region 25. Change in lean body mass by DXA absolute and relative to total body mass 26. Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score 27. Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score 28. Change in IWQOL-Lite-CT: • Physical Function • Psychosocial • Total score 29. Change in Control of Eating (CoEQ): • Craving Control score • Positive Mood score • Craving for Sweets score • Craving for Savoury food score • Hunger

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Countries

Argentina, Australia, Belgium, Bulgaria, Canada, Denmark, Finland, France, Germany, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Transparency (2834)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026