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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Novo Nordisk A/S

Investigators

  • 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)

August 27, 2026

Primary Completion (Estimated)

August 25, 2027

Study Completion (Estimated)

October 13, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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