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Completed

NCT Number: NCT06131437

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

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.

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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

Univ of Alabama Birmingham, Birmingham, Alabama, United States

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 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

Treatment and study plan

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

semaglutide

Drug

Semaglutide will be administered subcutaneously.

Tirzepatide

Drug

Tirzepatide will be administered subcutaneously.

Primary outcomes

  1. To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage (%).

Secondary outcomes

  1. To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage (%).

  2. Achievement of greater than or equal to (≥) 25% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Count of participants.

  3. Achievement of ≥ 30% weight reduction

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Count of participants.

  4. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in centimeter (cm).

  5. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in millimeter of mercury (mmHg).

  6. Change in diastolic blood pressure (DBP)

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in mmHg.

  7. Relative change in lipids: Total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  8. Relative change in lipids: High-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  9. Relative change in lipids: Non-HDL cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  10. Relative change in lipids: Low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  11. Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  12. Relative change in lipids: Triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 84)

    Measured in percentage.

  13. Number of Treatment-emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 90)

    Count of events.

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

    Time frame: From baseline (week 0) to end of study (week 90)

    Count of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 14, 2023
Registry last updated
Feb 6, 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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