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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity or Overweight
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan, 468-0009
    • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  • Bunkyo-ku, Tokyo, Japan, 113-8655
    • The University of Tokyo Hospital, Diabetes and Metabolic
  • Chiba-shi, Chiba, Japan, 260-0804
    • Akaicho Clinic
  • Chiyoda-ku, Tokyo, Japan, 101-0065
    • Suidoubashi Medical Clinic_Internal Medicine
  • Chuo-ku, Tokyo, Japan, 103-0002
    • The Institute of Medical Science, Asahi Life Foundation
  • Chuo-ku, Tokyo, Japan, 104-0061
    • Okabe Clinic
  • Chuo-ku, Tokyo, Japan, 103-0002
    • The Institute of Medical Science, Asahi Life Foundation_Internal Medicine
  • Gunma, Japan, 373-0036
    • Kawada Clinic
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic
  • Ibaraki, Japan, 311-0113
    • Naka Kinen Clinic_Internal medicine
  • Numakunai, Japan, 020-8505
    • Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine
  • Osaka, Japan, 530-0001
    • Osaka NISHI-UMEDA Clinic
  • Osaka, Japan, 530-0001
    • Osaka NISHI-UMEDA Clinic_Internal Medicine
  • Sapporo-shi, Hokkaido, Japan, 004-0004
    • Shinsapporo Seiryou Hospital, General Clinical Department
  • Sendai-shi, Miyagi, Japan, 983-0039
    • Shinden Higashi Clinic
  • Sendai-shi, Miyagi, Japan, 983-0039
    • Shinden Higashi Clinic_Internal medicine
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic
  • Tokyo, Japan, 103-0027
    • Tokyo-Eki Center-building Clinic_Internal Medicine
  • Tokyo, Japan, 104-0031
    • Fukuwa Clinic_Internal Medicine
  • Tokyo, Japan, 192-0918
    • Minamino Cardiovascular Hospital_Cardiovascular medicine
  • Tokyo, Japan, 160-0008
    • ToCROM Clinic_Internal Medicine
  • Fukushima, Japan
    • Koriyama-shi, Fukushima, Fukushima, Japan, Japan, 963-8851
      • Seino Internal Medicine Clinic_Internal medicine
  • Kanagawa
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Tsuruma Kaneshiro Diabetes Clinic
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
  • Miyazaki
    • Miyazaki, Miyazaki, Japan, 880-0034
      • Heiwadai Hospital_Internal Medicine
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • OCROM Clinic_Internal medicine
    • Yao-shi, Osaka, Japan, 581-0011
      • Yao Tokushukai General Hospital_Cardiovascular division
• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital_main

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Cagrilintide; Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks; Drug: Semaglutide; Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks 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	Drug: Semaglutide; Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks; Drug: Placebo Semaglutide; Participants will receive placebo matched to semaglutide

What is the study measuring?

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 68)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline	Measured in centimeter (cm)	From baseline (week 0) to end of treatment (week 68)
Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population	Measured as percentage point	From baseline (week 0) to end of treatment (week 68)
Change in VFA Measured by CT Scan in Subset of the Japanese Study Population	Measured in centimeter square (cm^2)	From baseline (week 0) to end of treatment (week 68)
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)	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)
Relative Change in Body Weight	Measured in percentage (%)	From baseline (week 0) to week 20
Change in Body Weight	Measured in kilogram (kg)	From baseline (week 0) to end of treatment (week 68)
Change in Body Mass Index (BMI)	Measured in kilogram per meter square (kg/m^2)	From baseline (week 0) to end of treatment (week 68)
Change in Glycated Haemoglobin (HbA1c)	Measured in percentage points	From baseline (week 0) to end of treatment (week 68)
Change in Fasting Plasma Glucose (FPG)	Measured as millimole per liter (mmol/L)	From baseline (week 0) to end of treatment (week 68)
Change in Fasting Insulin	Measured as milliunits per liter (mU/L)	From baseline (week 0) to end of treatment (week 68)
Change in Systolic Blood Pressure (SBP)	Measured in millimeter of mercury (mmHg)	From baseline (week 0) to end of treatment (week 68)
Change in Diastolic Blood Pressure (DBP)	Measured in millimeter of mercury (mmHg)	From baseline (week 0) to end of treatment (week 68)
Change in Total Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in High-Density Lipoprotein (HDL) Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in Low-Density Lipoprotein (LDL) Cholesterol	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in Very Low-Density Lipoprotein (VLDL)	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in Triglycerides	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in Free fatty Acids	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score	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	From baseline (week 0) to end of treatment (week 68)
Number of Treatment-Emergent Adverse Events (TEAEs)	Measured as count of events	From baseline (week 0) to end of study (week 75)
Number of Serious Adverse Events (SAEs)	Measured as count of events	From baseline (week 0) to end of study (week 75)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency' (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): March 7, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide; cagrilintide
• Other Study ID Numbers: NN9838-4762; U1111-1277-3764 (Other Identifier: World Health Organization (WHO)); jRCT2031220734 (Registry Identifier: jRCT (Japan))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes