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 With or Without an SGLT2 Inhibitor
- Summary
- 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.
- Short title
- 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 With or Without an SGLT2 Inhibitor
- Official title
- Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-04-06
- First posted
- 2024-01-24
- Registry last updated
- 2026-04-22
- Primary completion date
- 2026-03-04
- Start date
- 2024-01-16
- Actual participants
- 1,024
- Participants
- 1,024
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06221969
- ClinicalTrials.gov ID
- NCT06221969
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Change in glycated haemoglobin (HbA1c)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)-points.
Relative change in body weight
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
Change in HbA1c
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in %-points.
Change in fasting plasma glucose (FPG)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in millimoles per liter (mmol/L).
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Timeframe: At end of treatment (week 68)
Count of participant
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of greater than or equal to (≥) 5% weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 10% weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 15 % weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant
Achievement of ≥ 20 % weight reduction
Timeframe: From baseline (week 0) to end of treatment (week 68)
Count of participant
Change in systolic blood pressure
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury(mmHg).
Change in diastolic blood pressure
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in mmHg.
Change in waist circumference
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
Ratio to baseline in lipids: Total cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: Triglycerides
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Ratio to baseline in lipids: non-HDL cholesterol
Timeframe: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
Timeframe: From baseline (week 0) to end of treatment (week 68)
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.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3
Timeframe: From baseline (week 0) to end of treatment (week 68)
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.
Number of Treatment-emergent Adverse Events (TEAEs)
Timeframe: From baseline (week 0) to end of study (week 74)
Count of events
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter)
Timeframe: From baseline (week 0) to end of study (week 74)
Count of episodes
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Timeframe: From baseline (week 0) to end of study (week 74)
Count of episodes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes ≥ 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 with or without an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
- HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- Body mass index (BMI) of ≥ 30.0 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.
- 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 < 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 medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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.
- Synexus Clin Res-BirminghamBirmingham, United States
- Univ of Alabama_BirminghamBirmingham, United States
- Prime Medical Group, LLCGilbert, United States
- Velocity Clinical Research-PhoenixPhoenix, United States
- Synexus Rsch /Cnt Phnx Med CPhoenix, United States
- Arkansas Clinical ResearchLittle Rock, United States
- Unity Health-Searcy Medical CenterSearcy, United States
- Velocity Clin Res-Chula VistaChula Vista, United States
- Headlands Research California, LLCEscondido, United States
- Neighborhood HealthcareEscondido, United States
- St. Jude Heritage Yorba Linda - Pediatric Ste DFullerton, United States
- Diabetes & Endocrine Specialists - La MesaLa Mesa, United States
- Diabetes and Endocrine Specialists - La MesaLa Mesa, United States
- Velocity Clin Res San DiegoLa Mesa, United States
- Clinical Trials ResearchLincoln, United States
- Loma Linda Univ Hlth Cr EndoLoma Linda, United States
- Valley Clinical Trials, Inc.Northridge, United States
- Desert Oasis HealthcarePalm Springs, United States
- Velocity Clin Res - PanoramaPanorama City, United States
- Western University of Health SciencesPomona, United States
- Endocrinology Josel CabaccanSan Jose, United States
- Mills-Peninsula Medical CenterSan Mateo, United States
- NorCal Endocrinology and Internal MedicineSan Ramon, United States
- Premier Medical Center, Inc.Toluca Lake, United States
- Velocity Clin Res - PanoramaVan Nuys, United States
And 171 more, listed on the interactive page.
- 2023
- 2023-503789-21-00
- U1111-1282-5561
Related records
Drugs (3)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition