Obesity or Overweight Clinical Trial
Official 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
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.
| Status | Recruiting |
| Enrollment | 330 |
| Est. completion date | March 17, 2025 |
| Est. primary completion date | January 27, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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, a-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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology | Aichi | |
| Japan | The University of Tokyo Hospital, Diabetes and Metabolic | Bunkyo-ku, Tokyo | |
| Japan | Akaicho Clinic | Chiba-shi, Chiba | |
| Japan | Suidoubashi Medical Clinic | Chiyoda-ku, Tokyo | |
| Japan | Okabe Clinic | Chuo-ku, Tokyo | |
| Japan | The Institute of Medical Science, Asahi Life Foundation | Chuo-ku, Tokyo | |
| Japan | Kawada Clinic | Gunma | |
| Japan | Naka Kinen Clinic | Ibaraki | |
| Japan | Iwate Medical University Uchimaru Medical Center, Division of Diabetes and Metabolism and Endocrine medicine | Iwate | |
| Japan | Seino Internal Medicine Clinic | Koriyama-shi | Fukushima, Japan |
| Japan | Heiwadai Hospital | Miyazaki-shi | Miyazaki |
| Japan | AMC NISHI-UMEDA Clinic | Osaka | |
| Japan | Shinsapporo Seiryou Hospital, General Clinical Department | Sapporo-shi, Hokkaido | |
| Japan | Shinden Higashi Clinic | Sendai-shi, Miyagi | |
| Japan | OCROM Clinic | Suita-shi | Osaka |
| Japan | Fukuwa Clinic | Tokyo | |
| Japan | Minamino Cardiovascular Hospital | Tokyo | |
| Japan | ToCROM Clinic | Tokyo | |
| Japan | Tokyo-Eki Center-building Clinic | Tokyo | |
| Japan | Tsuruma Kaneshiro Diabetes Clinic | Yamato-shi | Kanagawa |
| Japan | Yao Tokushukai General Hospital | Yao-shi | Osaka |
| Taiwan | National Taiwan University Hospital | Taipei City |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Japan, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative Change in Body Weight | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Relative Change in Body Weight | Measured in percentage (%) | From baseline (week 0) to week 20 | |
| Secondary | Change in Body Weight | Measured in kilogram (kg) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | 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) | |
| Secondary | Change in Glycated Haemoglobin (HbA1c) | Measured in percentage points | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Measured as millimole per liter (mmol/L) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Fasting Insulin | Measured as milliunits per liter (mU/L) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Systolic Blood Pressure (SBP) | Measured in millimeter of mercury (mmHg) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Diastolic Blood Pressure (DBP) | Measured in millimeter of mercury (mmHg) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Total Cholesterol | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in High-Density Lipoprotein (HDL) Cholesterol | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Low-Density Lipoprotein (LDL) Cholesterol | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Very Low-Density Lipoprotein (VLDL) | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Triglycerides | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | Change in Free fatty Acids | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 68) | |
| Secondary | 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) | |
| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) | Measured as count of events | From baseline (week 0) to end of study (week 75) | |
| Secondary | Number of Serious Adverse Events (SAEs) | Measured as count of events | From baseline (week 0) to end of study (week 75) |
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