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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1277-3764 | Other Identifier | World Health Organization (WHO) | |
| jRCT2031220734 | Registry Identifier | jRCT (Japan) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CagriSema 2.4 mg/2.4 mg | Experimental | 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 |
|
| Semaglutide 2.4 mg | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cagrilintide | Drug | Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Body Weight | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) |
| 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 |
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Inclusion Criteria:
Diabetes-related for participant with T2D
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
Diabetes-related for participant with T2D
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency' (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seino Internal Medicine Clinic_Internal medicine | Koriyama-shi, Fukushima | Fukushima, Japan | 963-8851 | Japan | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42009015 | Derived | Yamauchi T, Becker NP, Hagemann CA, Huang KC, Kiyosue A, Lim S, Onishi Y, Kosuvaripalli A, Takano T, Ishigaki Y; REDEFINE 5 study group. 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. Lancet Diabetes Endocrinol. 2026 Jun;14(6):450-462. doi: 10.1016/S2213-8587(25)00402-4. Epub 2026 Apr 17. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| 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 |
|
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) |
| Tsuruma Kaneshiro Diabetes Clinic_Internal medicine |
| Yamato-shi |
| Kanagawa |
| 242-0004 |
| Japan |
| Tsuruma Kaneshiro Diabetes Clinic | Yamato-shi | Kanagawa | 242-0004 | Japan |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| OCROM Clinic_Internal medicine | Suita-shi | Osaka | 565-0853 | Japan |
| Yao Tokushukai General Hospital_Cardiovascular division | Yao-shi | Osaka | 581-0011 | Japan |
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi | 468-0009 | Japan |
| The University of Tokyo Hospital, Diabetes and Metabolic | Bunkyo-ku, Tokyo | 113-8655 | Japan |
| Akaicho Clinic | Chiba-shi, Chiba | 260-0804 | Japan |
| Suidoubashi Medical Clinic_Internal Medicine | Chiyoda-ku, Tokyo | 101-0065 | Japan |
| The Institute of Medical Science, Asahi Life Foundation_Internal Medicine | Chuo-ku, Tokyo | 103-0002 | Japan |
| The Institute of Medical Science, Asahi Life Foundation | Chuo-ku, Tokyo | 103-0002 | Japan |
| Okabe Clinic | Chuo-ku, Tokyo | 104-0061 | Japan |
| Kawada Clinic | Gunma | 373-0036 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Naka Kinen Clinic | Ibaraki | 311-0113 | Japan |
| Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine | Numakunai | 020-8505 | Japan |
| Osaka NISHI-UMEDA Clinic_Internal Medicine | Osaka | 530-0001 | Japan |
| Osaka NISHI-UMEDA Clinic | Osaka | 530-0001 | Japan |
| Shinsapporo Seiryou Hospital, General Clinical Department | Sapporo-shi, Hokkaido | 004-0004 | Japan |
| Shinden Higashi Clinic_Internal medicine | Sendai-shi, Miyagi | 983-0039 | Japan |
| Shinden Higashi Clinic | Sendai-shi, Miyagi | 983-0039 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Fukuwa Clinic | Tokyo | 104-0031 | Japan |
| ToCROM Clinic_Internal Medicine | Tokyo | 160-0008 | Japan |
| Minamino Cardiovascular Hospital_Cardiovascular medicine | Tokyo | 192-0918 | Japan |
| National Taiwan University Hospital_main | Taipei | 100 | Taiwan |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000717792 | cagrilintide |
| C000591245 | semaglutide |
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