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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT05813925 (opens ClinicalTrials.gov in a new tab)Other idNN9838-4762Other idU1111-1277-3764Other idjRCT2031220734
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
331 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

Japan, Taiwan

Start
3 Apr 2023
Primary completion
17 Jan 2025
Completion
7 Mar 2025
First posted
14 Apr 2023
Last update posted
22 Jan 2026
Conditions
Obesity or Overweight

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 3

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

    NCT05813925

    3 Apr 2023 to 7 Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • CagrilintideDrug
  • SemaglutideDrug
  • Placebo SemaglutideDrug

Arms2

  • Experimental

    CagriSema 2.4 mg/2.4 mg

    Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks

  • Active comparator

    Semaglutide 2.4 mg

    Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative Change in Body Weight

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

    Registry description

    Measured in percentage (%)

Secondary outcomes(20)

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    Measured as count of participants

  9. Relative Change in Body Weight

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

    Registry description

    Measured in percentage (%)

  10. Change in Body Weight

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

    Registry description

    Measured in kilogram (kg)

  11. Change in Body Mass Index (BMI)

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

    Registry description

    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)

    Registry description

    Measured in percentage points

  13. Change in Fasting Plasma Glucose (FPG)

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

    Registry description

    Measured as millimole per liter (mmol/L)

  14. Change in Fasting Insulin

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

    Registry description

    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)

    Registry description

    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)

    Registry description

    Measured in millimeter of mercury (mmHg)

  17. Change in Total Cholesterol

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

    Registry description

    Measured in percentage (%)

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

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

    Registry description

    Measured in percentage (%)

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

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

    Registry description

    Measured in percentage (%)

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

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

    Registry description

    Measured in percentage (%)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

13 results

Efficacy and safety of co-administered cagrilintide and semaglutide versus semaglutide alone in adults with overweight or obesity with or without type 2 diabetes in Japan and Taiwan (REDEFINE 5): a multicentre, randomised, active-controlled, phase 3a trial.

Yamauchi et al. 2026The lancet. Diabetes & endocrinologycited by 1

PMID 42009015DOI 10.1016/s2213-8587(25)00402-4PUB-42009015

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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