This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,024
Cagrilintide will be administered subcutaneously.
Semaglutide will be administered subcutaneously.
Tirzepatide will be administered subcutaneously.
Synexus Clin Res-Birmingham
Birmingham, Alabama, United States
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
Prime Medical Group, LLC
Gilbert, Arizona, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, United States
Change in glycated haemoglobin (HbA1c)
Measured in percentage (%)-points.
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 end of treatment (week 68)
Change in HbA1c
Measured in %-points.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in fasting plasma glucose (FPG)
Measured in millimoles per liter (mmol/L).
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Count of participant
Time frame: At end of treatment (week 68)
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of greater than or equal to (≥) 5% weight reduction
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 10% weight reduction
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 15 % weight reduction
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 20 % weight reduction
Count of participant
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure
Measured in millimeters of mercury(mmHg).
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in diastolic blood pressure
Measured in mmHg.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in waist circumference
Measured in centimeter (cm).
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: non-HDL cholesterol
Measured in ratio.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.
Time frame: From baseline (week 0) to end of treatment (week 68)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3
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. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning.
Time frame: From baseline (week 0) to end of treatment (week 68)
Number of Treatment-emergent Adverse Events (TEAEs)
Count of events
Time frame: From baseline (week 0) to end of study (week 74)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)
Count of episodes
Time frame: From baseline (week 0) to end of study (week 74)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Count of episodes
Time frame: From baseline (week 0) to end of study (week 74)
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Arkansas Clinical Research
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
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