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Diabetes Mellitus, Type 2Phase 2NCT07357740

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

A Phase 2 study testing CagriSema in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 61 sites in 8 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
CagriSema
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
61 sitesin 8 countries
Study dates
27 Aug 2026to 13 Oct 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

61 sites in 8 countries.

61 sites in 8 countries

United States21 sites

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Elevate Clinical Research

    Gurnee, Illinois, 60031

  • The Endocrine Center

    Houston, Texas, 77079

  • Radiance Clinical Research

    Lampasas, Texas, 76550

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Future Medical Research

    Longwood, Florida, 32750

  • Advanced Medical Research - Maumee

    Maumee, Ohio, 43537

  • New Horizon Research Center

    Miami, Florida, 33165

  • Clinical Site Partners Kendall Flourish Research

    Miami, Florida, 33186

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Accellacare of Duly Oak Lawn

    Oak Lawn, Illinois, 60453

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027

  • Quality Research Inc

    San Antonio, Texas, 78209

  • Paradigm Clinical Research

    San Diego, California, 92108

  • Medrasa Clinical Research

    Sherman, Texas, 75092

  • Encompass Clinical Research_Spring Valley

    Spring Valley, California, 91978

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • KDCILM, LLC & Accellacare US, Inc.

    Wilmington, North Carolina, 28401

Other trials in United States

Spain11 sites

  • Centro Periferico De Especialidades Bola Azul

    Almería, 04009

  • EBA Vallcarca SLP

    Barcelona, 08023

  • CAPSBE_CAP Ernest LLuch

    Barcelona, 08028

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Centro de Salud Cabra Matrona Antonia Mesa

    Cabra, 14940

  • CAP Alhambra

    L'Hospitalet de Llobregat, 08920

  • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

    Manresa, 08243

  • Centro de Salud Monzón Urbano

    Monzón, 22400

  • Centro de Salud Pola de Siero

    Pola de Siero, 33510

  • Centro de Salud San Juan de la Cruz

    Pozuelo de Alarcón, 28223

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

Other trials in Spain

Greece6 sites

  • Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases

    Athens, 11525

  • General Hospital Of Thessaloniki Papageorgiou - 3rd Department of Internal Medicine

    Efkarpia, 564 29

  • General University Hospital Of Patras - Endocrinology Department

    Pátrai, 265 04

  • Ippokratio General Hospital Of Thessaloniki - 2nd Propaedeutic Department of Internal Medicine

    Thessaloniki, 546 42

  • Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department

    Thessaloniki, 570 10

  • Thermi Clinic S.A. - Diabetes and Internal Medicine Department

    Thessaloniki, 57001

Other trials in Greece

Malaysia5 sites

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • Hospital Melaka

    Malacca, 75400

  • Hospital Miri

    Miri, Sarawak, 98000

  • Hospital Seberang Jaya

    Pulau Pinang, 13700

Other trials in Malaysia

Slovakia5 sites

  • Diakom, spol. s r.o.

    Poprad, 05801

  • MED-DIA CENTRUM s.r.o.

    Považská Bystrica, 01701

  • DIALIPID, s.r.o.

    Prešov, 080 01

  • iDia s. r. o.

    Žiar nad Hronom, 965 01

  • MEDIVASA, s.r.o., Diabetologicka ambulancia

    Žilina, 010 01

Other trials in Slovakia

Thailand5 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • RIHES-CMU_Research Institute for Health Sciences

    Chiang Mai, 50200

  • Thammasat Hospital_CRC

    Pathum Thani, 12120

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Denmark4 sites

  • Sanos Clinic - Gandrup

    Gandrup, 9362

  • Sanos Clinic - Herlev

    Herlev, 2730

  • Sanos Clinic - Vejle

    Vejle, Region Syddanmark, 7100

  • Regionshospitalet Viborg - Karkirurgisk Afsnit

    Viborg, 8800

Other trials in Denmark

Serbia4 sites

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000

  • University Clinical Centre Nis

    Niš, 18 000

Other trials in Serbia

About this study

Official title: 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.

Being tested
CagriSema, Placebo CagriSema
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagriSemaDrug

    Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.

  • Placebo CagriSemaDrug

    Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.

Study groups in NCT07357740
Study groupRoleWhat they receive
CagriSema in device 1 + Placebo CagriSema B in device 2ExperimentalParticipants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner.
Receives: Drug: CagriSema; Drug: Placebo CagriSema
CagriSema B in device 2 + Placebo CagriSema in device 1ExperimentalParticipants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner.
Receives: Drug: CagriSema; Drug: Placebo CagriSema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in glycated haemoglobin (HbA1c)

    Measured as percentage-points (%-points).

    Measured: Baseline to week 28

Secondary outcomes (4)

  1. Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses

    Measured in nanomoles per litre (nmol/L).

    Measured: From baseline to week 28

  2. Change in HbA1c

    Measured as %-points.

    Measured: From baseline to week 28

  3. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as count of events.

    Measured: From baseline to week 35

  4. 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)

    Measured as count of episodes.

    Measured: From baseline to week 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start27 Aug 2026 (estimated)
  3. Primary completion25 Aug 2027 (estimated)
  4. Study completion13 Oct 2027 (estimated)

Why it stopped: The study is withdrawn due to strategic reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357740
Sponsor's protocol ID
NN9388-8468
Other IDs
U1111-1323-3766, 2025-522570-37, 2025
Status last verified
Jul 2026
First submitted
21 Jan 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CagriSema in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 61 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Spain, Greece, Malaysia, Slovakia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in glycated haemoglobin (HbA1c) (time frame: Baseline to week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357740.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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