A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Relative Change in Body Weight [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
Secondary Outcome Measures
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent [From baseline (week 0) to end of treatment (week 68)]
Measured as count of participants
- Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline [From baseline (week 0) to end of treatment (week 68)]
Measured in centimeter (cm)
- Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population [From baseline (week 0) to end of treatment (week 68)]
Measured as percentage point
- Change in VFA Measured by CT Scan in Subset of the Japanese Study Population [From baseline (week 0) to end of treatment (week 68)]
Measured in centimeter square (cm^2)
- 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) [From baseline (week 0) to end of treatment (week 68)]
Measured as count of participants
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent [From baseline (week 0) to end of treatment (week 68)]
Measured as count of participants
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent [From baseline (week 0) to end of treatment (week 68)]
Measured as count of participants
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent [From baseline (week 0) to end of treatment (week 68)]
Measured as count of participants
- Relative Change in Body Weight [From baseline (week 0) to week 20]
Measured in percentage (%)
- Change in Body Weight [From baseline (week 0) to end of treatment (week 68)]
Measured in kilogram (kg)
- Change in Body Mass Index (BMI) [From baseline (week 0) to end of treatment (week 68)]
Measured in kilogram per meter square (kg/m^2)
- Change in Glycated Haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage points
- Change in Fasting Plasma Glucose (FPG) [From baseline (week 0) to end of treatment (week 68)]
Measured as millimole per liter (mmol/L)
- Change in Fasting Insulin [From baseline (week 0) to end of treatment (week 68)]
Measured as milliunits per liter (mU/L)
- Change in Systolic Blood Pressure (SBP) [From baseline (week 0) to end of treatment (week 68)]
Measured in millimeter of mercury (mmHg)
- Change in Diastolic Blood Pressure (DBP) [From baseline (week 0) to end of treatment (week 68)]
Measured in millimeter of mercury (mmHg)
- Change in Total Cholesterol [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in High-Density Lipoprotein (HDL) Cholesterol [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in Low-Density Lipoprotein (LDL) Cholesterol [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in Very Low-Density Lipoprotein (VLDL) [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in Triglycerides [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in Free fatty Acids [From baseline (week 0) to end of treatment (week 68)]
Measured in percentage (%)
- Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score [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
- Number of Treatment-Emergent Adverse Events (TEAEs) [From baseline (week 0) to end of study (week 75)]
Measured as count of events
- Number of Serious Adverse Events (SAEs) [From baseline (week 0) to end of study (week 75)]
Measured as count of events
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female
-
Age greater than to or equal 18 years at the time of signing informed consent
-
- Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m2 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Koriyama-shi | Fukushima, Japan | Japan | 963-8851 |
| 2 | Novo Nordisk Investigational Site | Miyazaki-shi | Miyazaki, Japan | Japan | 880-0034 |
| 3 | Novo Nordisk Investigational Site | Yao-shi | Osaka | Japan | 581-0011 |
| 4 | Novo Nordisk Investigational Site | Aichi | Japan | 468-0009 | |
| 5 | Novo Nordisk Investigational Site | Bunkyo-ku, Tokyo | Japan | 113-8655 | |
| 6 | Novo Nordisk Investigational Site | Chiba-shi, Chiba | Japan | 260-0804 | |
| 7 | Novo Nordisk Investigational Site | Chiyoda-ku, Tokyo | Japan | 101-0065 | |
| 8 | Novo Nordisk Investigational Site | Chuo-ku, Tokyo | Japan | 103-0002 | |
| 9 | Novo Nordisk Investigational Site | Chuo-ku, Tokyo | Japan | 104-0061 | |
| 10 | Novo Nordisk Investigational Site | Gunma | Japan | 373-0036 | |
| 11 | Novo Nordisk Investigational Site | Ibaraki | Japan | 311-0113 | |
| 12 | Novo Nordisk Investigational Site | Iwate | Japan | 020-8505 | |
| 13 | Novo Nordisk Investigational Site | Osaka | Japan | 530-0001 | |
| 14 | Novo Nordisk Investigational Site | Sapporo-shi, Hokkaido | Japan | 004-0004 | |
| 15 | Novo Nordisk Investigational Site | Sendai-shi, Miyagi | Japan | 983-0039 | |
| 16 | Novo Nordisk Investigational Site | Suita-shi, Osaka | Japan | 565-0853 | |
| 17 | Novo Nordisk Investigational Site | Tokyo | Japan | 103-0027 | |
| 18 | Novo Nordisk Investigational Site | Tokyo | Japan | 104-0031 | |
| 19 | Novo Nordisk Investigational Site | Tokyo | Japan | 160-0008 | |
| 20 | Novo Nordisk Investigational Site | Tokyo | Japan | 192-0918 | |
| 21 | Novo Nordisk Investigational Site | Yamato-shi, Kanagawa | Japan | 242-0004 | |
| 22 | Novo Nordisk Investigational Site | Taipei City | Taiwan | 10048 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency' (dept. 2834), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN9838-4762
- U1111-1277-3764