A Research Study to See How Much CagriSema Lowers Blood S... | NCT06221969

Studies
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

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Apr 22, 2026Actual

Enrollment

1,024Actual

Phase

Phase 3

Conditions

Type 2 Diabetes

Interventions

Cagrilintide
Semaglutide
Tirzepatide

Countries

United States
Argentina
Australia
Canada
Colombia
India
South Africa
Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1282-5561	Other Identifier	World Health Organization (WHO)
2023-503789-21-00	Other Identifier	European Medical Agency (EMA)

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2024Actual

Primary Completion Date

Mar 4, 2026Actual

Completion Date

Apr 6, 2026Actual

First Submitted Date

Jan 15, 2024

First Submission Date that Met QC Criteria

Jan 15, 2024

First Posted Date

Jan 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,024Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CagriSema	Experimental	Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.	Drug: Cagrilintide Drug: Semaglutide
Tirzepatide	Active Comparator	Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.	Drug: Tirzepatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cagrilintide	Drug	Cagrilintide will be administered subcutaneously.	CagriSema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in glycated haemoglobin (HbA1c)	Measured in percentage (%)-points.	From baseline (week 0) to end of treatment (week 68)
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Change in fasting plasma glucose (FPG)	Measured in millimoles per liter (mmol/L).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Synexus Clin Res-Birmingham		Birmingham	Alabama	35211	United States
Univ of Alabama_Birmingham

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D000067757	Glucagon-Like Peptide-1 Receptor
D000067756	Glucagon-Like Peptide Receptors
D043562	Receptors, G-Protein-Coupled
D011956	Receptors, Cell Surface
D008565	Membrane Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D011964	Receptors, Gastrointestinal Hormone
D018000	Receptors, Peptide

ID	Term
C000717792	cagrilintide
C000591245	semaglutide
D000098860	Tirzepatide