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

NCTNCT06221969Other idNN9388-4894Other idU1111-1282-5561Other id2023-503789-21-00Other id2023

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,024 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Open label (no masking)
Countries: 8 countries
United States, Argentina, Australia, Canada, Colombia, India, South Africa, Taiwan
Start: 16 Jan 2024
Primary completion: 4 Mar 2026
Completion: 6 Apr 2026
First posted: 24 Jan 2024
Last update posted: 4 Sept 2026
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2024202520262027

Ph 3
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
NCT06221969
16 Jan 2024 to 6 Apr 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CagrilintideDrug
SemaglutideDrug
TirzepatideDrug

Arms2

Experimental
CagriSema
Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
Active comparator
Tirzepatide
Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in percentage (%)-points.
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in percentage (%).

Secondary outcomes(20)

Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in %-points.
Change in fasting plasma glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in millimoles per liter (mmol/L).
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol])
Time frame · At end of treatment (week 68)
Registry description
Count of participant
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol)
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Count of participant
Achievement of greater than or equal to (≥) 5% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Count of participant
Achievement of ≥ 10% weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Count of participant
Achievement of ≥ 15 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Count of participant
Achievement of ≥ 20 % weight reduction
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Count of participant
Change in systolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in millimeters of mercury(mmHg).
Change in diastolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in mmHg.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in centimeter (cm).
Ratio to baseline in lipids: Total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Ratio to baseline in lipids: non-HDL cholesterol
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
Measured in ratio.
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
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
Time frame · From baseline (week 0) to end of treatment (week 68)
Registry description
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)
Time frame · From baseline (week 0) to end of study (week 74)
Registry description
Count of events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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 ≥ 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. 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 \< 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.

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