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OpenTrials
Completed

NCT Number: NCT06388187

A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years 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

Ocean West Research Clinic, Surrey, British Columbia, Canada

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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 kilogram per meter square (kg/m^2) or
  • BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

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

Treatment and study plan

Cagrilintide

Drug

Participants will receive once-weekly cagrilintide subcutaneously.

semaglutide

Drug

Participants will receive once-weekly semaglutide subcutaneously.

Placebo

Drug

Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.

Primary outcomes

  1. Relative change in body weight

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

    Measured in percentage (%).

  2. Achievement of ≥5% weight reduction

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

    Measured as count of participant.

Secondary outcomes

  1. Achievement of ≥10% weight reduction

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

    Measured as count of participant.

  2. Achievement of ≥15% weight reduction

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

    Measured as count of participant.

  3. Achievement of ≥20% weight reduction

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

    Measured as count of participant.

  4. Change in waist circumference

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

    Measured in centimeter (cm).

  5. Change in systolic blood pressure

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

    Measured in millimeters of mercury.

  6. Ratio to baseline in lipids: Total cholesterol

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

    Measured in ratio.

  7. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

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

    Measured in ratio.

  8. Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

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

    Measured in ratio.

  9. Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

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

    Measured in ratio.

  10. Ratio to baseline in lipids: Triglycerides

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

    Measured in ratio.

  11. Ratio to baseline in lipids: Free fatty acids

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

    Measured in ratio.

  12. Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 74)

    Measured as count of events.

  13. Number of treatment emergent serious adverse events (TESAEs)

    Time frame: From baseline (week 0) to end of study (week 74)

    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. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2024
Registry last updated
May 5, 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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