A Research Study to See How Much CagriSema Lowers Blood S... | NCT06534411

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, SGLT2 Inhibitor or Both

NCT06534411

Sponsor

Novo Nordisk A/S

Status

Active, not recruiting

Last Update Posted

Jun 9, 2026Actual

Enrollment

1,023Actual

Phase

Phase 3

Conditions

Diabetes Mellitus, Type 2

Interventions

Cagrilintide
Semaglutide
Tirzepatide

Countries

United States
Argentina
Australia
Brazil
Canada
Germany
Greece
Hungary
India
Israel
Poland
Romania
Spain
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
U1111-1300-2590	Other Identifier	World Health Organization (WHO)
2023-509600-15	Other Identifier	European Medical Agency (EMA)

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2024Actual

Primary Completion Date

Jun 2, 2026Estimated

Completion Date

Jul 14, 2026Estimated

First Submitted Date

Jul 30, 2024

First Submission Date that Met QC Criteria

Jul 30, 2024

First Posted Date

Aug 2, 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

Jun 8, 2026

Last Update Posted Date

Jun 9, 2026Actual

Description Module

Brief Summary

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.

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

1,023Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CagriSema	Experimental	Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every 4 weeks in a 8-week dose escalation period until target dose of CagriSema is achieved and maintained for 52 weeks.	Drug: Cagrilintide Drug: Semaglutide
Tirzepatide	Experimental	Participants will receive once-weekly s.c injections of tirzepatide at escalating dose in a 4-week dose escalating period and maintained up to 56 weeks.	Drug: Tirzepatide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cagrilintide	Drug	Participants will receive once-weekly cagrilintide 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 60)
Relative Change in Body Weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 60)

Secondary Outcomes

Measure	Description	Time Frame
Change in HbA1c	Measured in percentage points.	From baseline (week 0) to end of treatment (week 60)
Change in Fasting Plasma Glucose (FPG)	Measured as millimole 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 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.

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
Cahaba Research		Pelham	Alabama	35124	United States
Velocity Clinical Research-Phoenix

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