A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes

March 26, 2026 updated by: Novo Nordisk A/S

A Phase 2 Study to Compare Two Presentations of CagriSema in Participants With Type 2 Diabetes

This study is being done to look at how well a study medicine called CagriSema helps people with diabetes lower their blood sugar. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Gandrup, Denmark, 9362
        • Sanos Clinic - Gandrup
      • Herlev, Denmark, 2730
        • Sanos Clinic - Herlev
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg - Karkirurgisk Afsnit
    • Region Syddanmark
      • Vejle, Region Syddanmark, Denmark, 7100
        • Sanos Clinic - Vejle
  • Greece
      • Athens, Greece, 11525
        • Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases
      • Efkarpia, Greece, 564 29
        • General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine
      • Pátrai, Greece, 265 04
        • General University Hospital Of Patras - Endocrinology Department
      • Thessaloniki, Greece, 57001
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
      • Thessaloniki, Greece, 546 42
        • Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine
      • Thessaloniki, Greece, 570 10
        • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur
      • Malacca, Malaysia, 75400
        • Hospital Melaka
      • Pulau Pinang, Malaysia, 13700
        • Hospital Seberang Jaya
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Hospital Miri
  • Serbia
      • Belgrade, Serbia, 11000
        • Endocrinology, Diabetes and Metabolism Diseases Clinic
      • Belgrade, Serbia, 11000
        • CHC Zvezdara, Clinical department for endocrinology
      • Kragujevac, Serbia, 34000
        • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
      • Niš, Serbia, 18 000
        • University Clinical Centre Nis
  • Slovakia
      • Poprad, Slovakia, 05801
        • Diakom, spol. s r.o.
      • Považská Bystrica, Slovakia, 01701
        • MED-DIA CENTRUM s.r.o.
      • Prešov, Slovakia, 080 01
        • DIALIPID, s.r.o.
      • Žiar nad Hronom, Slovakia, 965 01
        • iDia s. r. o.
      • Žilina, Slovakia, 010 01
        • MEDIVASA, s.r.o., Diabetologicka ambulancia
  • Spain
      • Almería, Spain, 04009
        • Centro Periferico De Especialidades Bola Azul
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08023
        • EBA Vallcarca SLP
      • Barcelona, Spain, 08028
        • CAPSBE_CAP Ernest LLuch
      • Cabra, Spain, 14940
        • Centro de Salud Cabra Matrona Antonia Mesa
      • L'Hospitalet de Llobregat, Spain, 08920
        • CAP Alhambra
      • Manresa, Spain, 08243
        • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
      • Monzón, Spain, 22400
        • Centro de Salud Monzón Urbano
      • Pola de Siero, Spain, 33510
        • Centro de Salud Pola de Siero
      • Pozuelo de Alarcón, Spain, 28223
        • Centro de Salud San Juan de la Cruz
      • Seville, Spain, 41003
        • Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • RIHES-CMU_Research Institute for Health Sciences
      • Pathum Thani, Thailand, 12120
        • Thammasat Hospital_CRC
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Clinical Research
    • California
      • San Diego, California, United States, 92108
        • Paradigm Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Longwood, Florida, United States, 32750
        • Future Medical Research
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Miami, Florida, United States, 33186
        • Clinical Site Partners Kendall Flourish Research
      • Ocoee, Florida, United States, 34761
        • West Orange Endocrinology
      • Pembroke Pines, Florida, United States, 33027
        • American Research Centers of Florida
      • Pembroke Pines, Florida, United States, 33024
        • Center for Diab,Obes & Metab
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Hope Clin Res & Wellness
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Elevate Clinical Research
      • Oak Lawn, Illinois, United States, 60453
        • Accellacare of Duly Oak Lawn
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • KDCILM, LLC & Accellacare US, Inc.
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Advanced Medical Research - Maumee
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Clinical Res Collaborative
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Houston, Texas, United States, 77079
        • The Endocrine Center
      • Lampasas, Texas, United States, 76550
        • Radiance Clinical Research
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc
      • Sherman, Texas, United States, 75092
        • Medrasa Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 [millimoles per mole] mmol/mol) (both inclusive) as determined by the central laboratory at screening.
  • Stable daily dose >= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator.
  • Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by the 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.
  • 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.
  • Previous exposure to CagriSema in a clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CagriSema in device 1 + Placebo CagriSema B in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner.
Drug: Placebo CagriSema
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Drug: CagriSema
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
Experimental: CagriSema B in device 2 + Placebo CagriSema in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner.
Drug: Placebo CagriSema
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Drug: CagriSema
Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in glycated haemoglobin (HbA1c)
Time Frame: Baseline to week 28
Measured as percentage-points (%-points).
Baseline to week 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses
Time Frame: From baseline to week 28
Measured in nanomoles per litre (nmol/L).
From baseline to week 28
Change in HbA1c
Time Frame: From baseline to week 28
Measured as %-points.
From baseline to week 28
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame: From baseline to week 35
Measured as count of events.
From baseline to week 35
Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)
Time Frame: From baseline to week 35
Measured as count of episodes.
From baseline to week 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 25, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9388-8468
  • U1111-1323-3766 (Other Identifier: World Health Organization (WHO))
  • 2025-522570-37 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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