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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005435-75-FR

Enrollment

3400

Registered

2022-07-25

Start date

2023-04-14

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 - 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 weight related comorbidity 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 : oCagriSema 2.4 mg/2.4 mg versus placebo on achievement of = 20%, 25%, 30% weight reduction. oCagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on body weight. oCagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on body weight. oCagriSema 0.5 mg/0.5 mg versus placebo on body weight. oCagriSema 2.4 mg/2.4 mg versus placebo on body weight. oCagriSema 2.4 mg/2.4 mg versus placebo on waist circumference, systolic blood pressure, physical functioning To compare the effect of : oCagriSema 2.4 mg/2.4 mg versus placebo on glucose metabolism, diastolic blood pressure, lipids oCagriSema 2.4 mg/2.4 mg versus placebo on body composition (for the DXA subgroup) oCagriSema 2.4 mg/2.4 mg versus placebo on SF-36v2 physical and mental components of health, IWQOL-Lite Impact of weight on quality of life To compare the safety and tolerability of : oCagriSema 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 : oCagriSema 2.4 mg/2.4 mg versus placebo on achievement of = 20%, 25%, 30% weight reduction. oCagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg on body weight. oCagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg on body weight. oCagriSema 0.5 mg/0.5 mg versus placebo on body weight. oCagriSema 2.4 mg/2.4 mg versus placebo on body weight. oCagriSema 2.4 mg/2.4 mg versus placebo on waist circumference, systolic blood pressure, physical functioning To compare the effect of : oCagriSema 2.4 mg/2.4 mg versus placebo on glucose metabolism, diastolic blood pressure, lipids oCagriSema 2.4 mg/2.4 mg versus placebo on body composition (for the DXA subgroup) oCagriSema 2.4 mg/2.4 mg versus placebo on SF-36v2 physical and mental components of health, IWQOL-Lite Impact of weight on quality of life To compare the safety and tolerability of : oCagriSema 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 equal to or greater than 20% weight reduction 2. Achievement of equal to or greater than 25% weight reduction 3. Achievement of equal to or greater than 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 Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score 10. Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score 11. Change in Glycated Haemoglobin (HbA1c) 12. Change in Fasting Plasma Glucose (FPG) 13. Relative change in fasting serum insulin 14. Change in Diastolic Blood Pressure (DBP) 15. Relative change in lipids: • Total cholesterol • High-density lipoprotein (HDL) cholesterol • Low-density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids 16. Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass 17. Relative change in visceral fat mass by DXA (For the DXA subgroup) 18. Change in lean body mass by DXA (For the DXA subgroup) relative to total body mass 19. Change in SF-36v2: • Physical Component Summary score • Mental Component Summary score 20. Change in IWQOL-Lite-CT Total score 21. Number of Treatment-emergent Adverse Events (TEAEs) 22. Number of Treatment-emergent Serious adverse events (TESAEs);Timepoint(s) of evaluation of this end point: 1.-4. From baseline (week 0) to end of treatment (week 68) 5. From baseline (week 0) to week 8 6.From baseline (week 0) to week 20 7.-20. From baseline (week 0) to end of treatment (week 68) 21.-22. From baseline (week 0) to end of study (main) (week 75)	—

Measure

Time frame

Secondary end point(s): 1. Achievement of equal to or greater than 20% weight reduction 2. Achievement of equal to or greater than 25% weight reduction 3. Achievement of equal to or greater than 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 Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score 10. Change in Short Form-36 Version 2.0 (SF-36v2) Physical Functioning score 11. Change in Glycated Haemoglobin (HbA1c) 12. Change in Fasting Plasma Glucose (FPG) 13. Relative change in fasting serum insulin 14. Change in Diastolic Blood Pressure (DBP) 15. Relative change in lipids: • Total cholesterol • High-density lipoprotein (HDL) cholesterol • Low-density lipoprotein (LDL) cholesterol • Very low-density lipoprotein (VLDL) cholesterol • Triglycerides • Free fatty acids 16. Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass 17. Relative change in visceral fat mass by DXA (For the DXA subgroup) 18. Change in lean body mass by DXA (For the DXA subgroup) relative to total body mass 19. Change in SF-36v2: • Physical Component Summary score • Mental Component Summary score 20. Change in IWQOL-Lite-CT Total score 21. Number of Treatment-emergent Adverse Events (TEAEs) 22. Number of Treatment-emergent Serious adverse events (TESAEs);Timepoint(s) of evaluation of this end point: 1.-4. From baseline (week 0) to end of treatment (week 68) 5. From baseline (week 0) to week 8 6.From baseline (week 0) to week 20 7.-20. From baseline (week 0) to end of treatment (week 68) 21.-22. From baseline (week 0) to end of study (main) (week 75)

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Countries

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

Contacts

Public ContactClinical Transparency (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

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