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

Novo Nordisk A/S331 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

331

Conditions

Obesity or Overweight

Interventions

CagrilintideDRUG

Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

SemaglutideDRUG

Participants will receive 2.4 mg semaglutide s.c. OW after a dose escalation period of 16 weeks for 52 weeks

Placebo SemaglutideDRUG

Participants will receive placebo matched to semaglutide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (28)

Outcomes

Primary Outcomes

Relative Change in Body Weight

Measured in percentage (%)

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

Secondary Outcomes

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

Measured as count of participants

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

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

Data from ClinicalTrials.gov

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Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, Fukushima, Japan, Japan

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, Japan

Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, Japan

Heiwadai Hospital_Internal Medicine

Miyazaki, Miyazaki, Japan

OCROM Clinic_Internal medicine

Suita-shi, Osaka, Japan

Yao Tokushukai General Hospital_Cardiovascular division

Yao-shi, Osaka, 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_Internal Medicine

Chiyoda-ku, Tokyo, Japan

...and 18 more locations

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

Measured as count of participants

Time frame: 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

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

Relative Change in Body Weight

Measured in percentage (%)

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

Change in Body Weight

Measured in kilogram (kg)

Time frame: 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)

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

Change in Glycated Haemoglobin (HbA1c)

Measured in percentage points

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

Change in Fasting Plasma Glucose (FPG)

Measured as millimole per liter (mmol/L)

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

Change in Fasting Insulin

Measured as milliunits per liter (mU/L)

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

Change in Systolic Blood Pressure (SBP)

Measured in millimeter of mercury (mmHg)

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

Change in Diastolic Blood Pressure (DBP)

Measured in millimeter of mercury (mmHg)

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

Change in Total Cholesterol

Measured in percentage (%)

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

Change in High-Density Lipoprotein (HDL) Cholesterol

Measured in percentage (%)

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

Change in Low-Density Lipoprotein (LDL) Cholesterol

Measured in percentage (%)

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

Change in Very Low-Density Lipoprotein (VLDL)

Measured in percentage (%)

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

Change in Triglycerides

Measured in percentage (%)

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

Change in Free fatty Acids

Measured in percentage (%)

Time frame: 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

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

Number of Treatment-Emergent Adverse Events (TEAEs)

Measured as count of events

Time frame: From baseline (week 0) to end of study (week 75)

Number of Serious Adverse Events (SAEs)

Measured as count of events

Time frame: From baseline (week 0) to end of study (week 75)