A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Study Overview
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Brief Summary
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This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Official Title
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Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Drug: Cagrilintide
* Drug: Semaglutide
* Drug: Tirzepatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Age 18 years or above at the time of signing the informed consent Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2) Exclusion Criteria: Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening History of type 1 or type 2 diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CagriSema 2.4 mg/2.4 mg<br>Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 72 weeks. | Drug: Cagrilintide<br>* Cagrilintide will be administered subcutaneously.<br>Drug: Semaglutide<br>* Semaglutide will be administered subcutaneously.<br>|
| Active Comparator: Tirzepatide 15 mg<br>Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 72 weeks. | Drug: Tirzepatide<br>* Tirzepatide will be administered subcutaneously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change in body weight | Measured in percentage (%). | From baseline (week 0) to end of treatment (week 72) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of greater than or equal to (≥) 25% weight reduction | Count of participant. | From baseline (week 0) to end of treatment (week 72) | 
| Achievement of ≥ 30% weight reduction | Count of participant. | From baseline (week 0) to end of treatment (week 72) | 
| Change in waist circumference | Measured in centimeter (cm). | From baseline (week 0) to end of treatment (week 72) | 
| Change in systolic blood pressure (SBP) | Measured in millimeter of mercury (mmHg). | From baseline (week 0) to end of treatment (week 72) | 
| Change in diastolic blood pressure (DBP) | Measured in mmHg. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: Total cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: High-density lipoprotein (HDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: Non-HDL cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: Low-density lipoprotein (LDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Relative change in lipids: Triglycerides | Measured in percentage. | From baseline (week 0) to end of treatment (week 72) | 
| Number of Treatment-emergent Adverse Events (TEAEs) | Count of events. | From baseline (week 0) to end of study (week 78) | 
| Number of Treatment Emergent Serious adverse events (TESAEs) | Count of events. | From baseline (week 0) to end of study (week 78) |