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OpenTrials
Completed

NCT Number: NCT05813925

A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight

This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ years.

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Key information

Conditions

Obesity or Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity 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

Seino Internal Medicine Clinic_Internal medicine, Koriyama-shi, Fukushima, Fukushima, Japan, Japan

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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 greater than to or equal 18 years at the time of signing informed consent
  • a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D

Diabetes-related for participant with T2D

  • Diagnosed with T2D greater than or equal to 180 days before screening
  • HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening
  • Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors [AGI], glinides, sodium-glucose cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening

Exclusion criteria

Obesity-related

  • Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening

Glycaemia-related for participant without T2D

  • HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes

Diabetes-related for participant with T2D

  • Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2) as measured by central laboratory at screening
  • Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Treatment and study plan

Cagrilintide

Drug

Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

semaglutide

Drug

Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

Placebo Semaglutide

Drug

Participants will receive placebo matched to semaglutide

Primary outcomes

  1. Relative Change in Body Weight

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

    Measured in percentage (%)

Secondary outcomes

  1. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

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

    Measured as count of participants

  2. Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline

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

    Measured in centimeter (cm)

  3. Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population

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

    Measured as percentage point

  4. Change in VFA Measured by CT Scan in Subset of the Japanese Study Population

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

    Measured in centimeter square (cm^2)

  5. Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)

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

    Measured as count of participants

  6. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent

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

    Measured as count of participants

  7. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

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

    Measured as count of participants

  8. Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

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

    Measured as count of participants

  9. Relative Change in Body Weight

    Time frame: From baseline (week 0) to week 20

    Measured in percentage (%)

  10. Change in Body Weight

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

    Measured in kilogram (kg)

  11. Change in Body Mass Index (BMI)

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

    Measured in kilogram per meter square (kg/m^2)

  12. Change in Glycated Haemoglobin (HbA1c)

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

    Measured in percentage points

  13. Change in Fasting Plasma Glucose (FPG)

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

    Measured as millimole per liter (mmol/L)

  14. Change in Fasting Insulin

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

    Measured as milliunits per liter (mU/L)

  15. Change in Systolic Blood Pressure (SBP)

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

    Measured in millimeter of mercury (mmHg)

  16. Change in Diastolic Blood Pressure (DBP)

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

    Measured in millimeter of mercury (mmHg)

  17. Change in Total Cholesterol

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

    Measured in percentage (%)

  18. Change in High-Density Lipoprotein (HDL) Cholesterol

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

    Measured in percentage (%)

  19. Change in Low-Density Lipoprotein (LDL) Cholesterol

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

    Measured in percentage (%)

  20. Change in Very Low-Density Lipoprotein (VLDL)

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

    Measured in percentage (%)

  21. Change in Triglycerides

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

    Measured in percentage (%)

  22. Change in Free fatty Acids

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

    Measured in percentage (%)

  23. Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score

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

    IWQOL-Lite-CT is a 20-item patient reported outcome (PRO) instrument used to assess the impact of body weight changes in obesity studies on patient's physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score

  24. Number of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From baseline (week 0) to end of study (week 75)

    Measured as count of events

  25. Number of Serious Adverse Events (SAEs)

    Time frame: From baseline (week 0) to end of study (week 75)

    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. 2.4 mg in Combination With Semaglutide S.C. 2.4 mg (CagriSema S.C. 2.4 mg/2.4 mg) Once-Weekly in East Asian Participants With Overweight or Obesity

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Jan 22, 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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