A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

Novo Nordisk A/S1,023 enrolled

Overview

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,023

Conditions

Diabetes Mellitus, Type 2

Interventions

Cagrilintide

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: * Metformin * sodium-glucose co-transporter 2 inhibitor (SGLT2i) * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye 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 (163)

Cahaba Research

Pelham, Alabama, United States

Velocity Clinical Research-Phoenix

Phoenix, Arizona, United States

AES Tucson DRS

Tucson, Arizona, United States

Woodland Int. Research Group

Little Rock, Arkansas, United States

Velocity Clin Res-Chula Vista

Chula Vista, California, United States

Outcomes

Primary Outcomes

Change in Glycated Haemoglobin (HbA1c)

Measured in percentage points.

Time frame: From baseline (week 0) to end of treatment (week 60)

Relative Change in Body Weight

Measured in percentage (%).

Time frame: From baseline (week 0) to end of treatment (week 60)

Secondary Outcomes

Change in HbA1c

Measured in percentage points.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Fasting Plasma Glucose (FPG)

Measured as millimole per liter (mmol/L).

Time frame: From baseline (week 0) to end of treatment (week 60)

Number of Participants Who Achieve HbA1c Target Values of Less Than (<) 7.0 (Percent [%]) (< 53 millimole per mole [mmol/mol])

Measured as count of participants.

Time frame: At end of treatment (week 60)

Number of Participants Who Achieve HbA1c Target Values of Less Than or Equal to (<=) 6.5% (<= 48 mmol/mol)

Measured as count of participants.

Time frame: At end of treatment (week 60)

Number of Participants Who Achieve Greater Than or Equal to (>=) 5% Weight Reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 60)

Number of Participants Who Achieve >= 10% Weight Reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 60)

Number of Participants Who Achieve >= 15% Weight Reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 60)

Number of Participants Who Achieve >= 20% Weight Reduction

Measured as count of participants.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Systolic Blood Pressure (SBP)

Measured in millimeter of mercury (mmHg).

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Diastolic Blood Pressure (DBP)

Measured in mmHg.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Waist Circumference

Measured in centimeter (cm).

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: Total Cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: Triglycerides

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Ratio to Baseline in Lipids: Non-HDL cholesterol

Measured as ratio.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Short Form (SF) -36v2 Score: Physical Component Summary Score

Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Physical component summary scores ranges from 6.1 to 79.7 with higher scores indicating better functional health and well-being.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in SF-36v2 Score: Mental Component Summary Score

Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Mental component summary scores ranges from -3.8 to 78.7 with higher scores indicating better functional health and well-being.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in SF-36v2 Score: Vitality Subscale

Measured as score points. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Vitality score ranges from 25.6 to 69.1 with higher scores indicating better functional health and well-being.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in Impact of Weight on Quality of Life Lite for Clinical Trials Version (IWQOL-Lite-CT) : Physical Function score

Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Physical functioning score ranges from 0 to 100, with higher scores reflecting better levels of functioning.

Time frame: From baseline (week 0) to end of treatment (week 60)

Change in IWQOL-Lite-CT: Total score

Measured as score points. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Total score ranges from 0 to 100, with higher scores reflecting better levels of functioning.

Time frame: From baseline (week 0) to end of treatment (week 60)

Number of Treatment Emergent Adverse Events (TEAEs)

Measured as count of events.

Time frame: From baseline (week 0) to end of study (week 66)

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (<54 Milligram per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter

Measured as count of episodes.

Time frame: From baseline (week 0) to end of study (week 66)

Number of Severe Hypoglycaemic Episodes (Level 3): Hypoglycaemia Associated With Severe Cognitive Impairment Requiring External Assistance for Recovery, With no Specific Glucose Threshold

Measured as count of episodes.

Time frame: From baseline (week 0) to end of study (week 66)