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

NCT07357740 | Not Yet Recruiting Phase 2 FDA Drug

• 3 other identifiers: NN9388-8468U1111-1323-37662025-522570-37
• Study Type: interventional
• Target: 400
• Locations: 8 countries
• Sites: 61

Brief 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. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. The study will last for about 38 weeks.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c)

  Measured as percentage-points (%-points).

  Baseline to week 28

Secondary Outcomes (4)

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

  From baseline to week 28

• Change in HbA1c

  From baseline to week 28

• Number of Treatment Emergent Adverse Events (TEAEs)

  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)

  From baseline to week 35

Study Arms (2)

CagriSema in device 1 + Placebo CagriSema B in device 2

EXPERIMENTAL

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: CagriSema; Drug: Placebo CagriSema

CagriSema B in device 2 + Placebo CagriSema in device 1

EXPERIMENTAL

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: CagriSema; Drug: Placebo CagriSema

Interventions

CagriSema DRUG

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

CagriSema B in device 2 + Placebo CagriSema in device 1; CagriSema in device 1 + Placebo CagriSema B in device 2

Placebo CagriSema DRUG

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

CagriSema B in device 2 + Placebo CagriSema in device 1; CagriSema in device 1 + Placebo CagriSema B in device 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (61)

Arkansas Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Paradigm Clinical Research

San Diego, California, 92108, United States

Location

Encompass Clinical Research_Spring Valley

Spring Valley, California, 91978, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Future Medical Research

Longwood, Florida, 32750, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Clinical Site Partners Kendall Flourish Research

Miami, Florida, 33186, United States

Location

West Orange Endocrinology

Ocoee, Florida, 34761, United States

Location

Center for Diab,Obes & Metab

Pembroke Pines, Florida, 33024, United States

Location

American Research Centers of Florida

Pembroke Pines, Florida, 33027, United States

Location

Hope Clin Res & Wellness

Conyers, Georgia, 30094, United States

Location

Elevate Clinical Research

Gurnee, Illinois, 60031, United States

Location

Accellacare of Duly Oak Lawn

Oak Lawn, Illinois, 60453, United States

Location

KDCILM, LLC & Accellacare US, Inc.

Wilmington, North Carolina, 28401, United States

Location

Advanced Medical Research - Maumee

Maumee, Ohio, 43537, United States

Location

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

Location

Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

The Endocrine Center

Houston, Texas, 77079, United States

Location

Radiance Clinical Research

Lampasas, Texas, 76550, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Medrasa Clinical Research

Sherman, Texas, 75092, United States

Location

Sanos Clinic - Vejle

Vejle, Region Syddanmark, 7100, Denmark

Location

Sanos Clinic - Gandrup

Gandrup, 9362, Denmark

Location

Sanos Clinic - Herlev

Herlev, 2730, Denmark

Location

Regionshospitalet Viborg - Karkirurgisk Afsnit

Viborg, 8800, Denmark

Location

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

Athens, 11525, Greece

Location

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

Efkarpia, 564 29, Greece

Location

General University Hospital Of Patras - Endocrinology Department

Pátrai, 265 04, Greece

Location

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

Thessaloniki, 546 42, Greece

Location

Geniko Nosokomeio Thessalonikis George Papanikolaou - Internal Medicine and Diabetes Department

Thessaloniki, 570 10, Greece

Location

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

Thessaloniki, 57001, Greece

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Miri

Miri, Sarawak, 98000, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Melaka

Malacca, 75400, Malaysia

Location

Hospital Seberang Jaya

Pulau Pinang, 13700, Malaysia

Location

CHC Zvezdara, Clinical department for endocrinology

Belgrade, 11000, Serbia

Location

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, 11000, Serbia

Location

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

Kragujevac, 34000, Serbia

Location

University Clinical Centre Nis

Niš, 18 000, Serbia

Location

Diakom, spol. s r.o.

Poprad, 05801, Slovakia

Location

MED-DIA CENTRUM s.r.o.

Považská Bystrica, 01701, Slovakia

Location

DIALIPID, s.r.o.

Prešov, 080 01, Slovakia

Location

iDia s. r. o.

Žiar nad Hronom, 965 01, Slovakia

Location

MEDIVASA, s.r.o., Diabetologicka ambulancia

Žilina, 010 01, Slovakia

Location

Centro Periferico De Especialidades Bola Azul

Almería, 04009, Spain

Location

EBA Vallcarca SLP

Barcelona, 08023, Spain

Location

CAPSBE_CAP Ernest LLuch

Barcelona, 08028, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Centro de Salud Cabra Matrona Antonia Mesa

Cabra, 14940, Spain

Location

CAP Alhambra

L'Hospitalet de Llobregat, 08920, Spain

Location

Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada

Manresa, 08243, Spain

Location

Centro de Salud Monzón Urbano

Monzón, 22400, Spain

Location

Centro de Salud Pola de Siero

Pola de Siero, 33510, Spain

Location

Centro de Salud San Juan de la Cruz

Pozuelo de Alarcón, 28223, Spain

Location

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

Location

Phramongkutklao Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

RIHES-CMU_Research Institute for Health Sciences

Chiang Mai, 50200, Thailand

Location

Thammasat Hospital_CRC

Pathum Thani, 12120, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): August 27, 2026
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): October 13, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (4); US (21); SE (4); MY (5); SL (5); GR (6); ES (11); TH (5)