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NCT06323174CompletedPhase 3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
189 (actual)
First submitted
15 Mar 2024
Start date
19 Mar 2024
Primary completion date
1 Oct 2025
Lead sponsor
Novo Nordisk A/S
NCT number
NCT06323174
EU CT number
2022-502677-42-00
EudraCT number
2022-502677-42

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 189
  • From 19 Mar 2024 to the primary completion date, 1 Oct 2025
  • 50 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with any medication for the indication of diabetes or obesity within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
  • History of use of any injectable therapy for diabetes or obesity. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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

Lab values

  • 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

Other

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method

Who the study is looking for

  • Male or female
  • Age 18 years or above at the time of signing the informed consent
  • Diagnosed with type 2 diabetes \>=30 days before screening
  • HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
  • Body mass index (BMI) \>=23 kilograms 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese People's Liberation Army General Hospital-Endocrinology
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BeijingChinaUnknown status
Jinan Central Hospital
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Ji'nanChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
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NanjingChinaUnknown status
The Affiliated Hospital of Jiangsu University-Endocrinology
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ZhenjiangChinaUnknown status
Szent Margit Rendelointezet Nonprofit Kft.
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Budapest IIIHungaryCompleted
PVN Kutato Kft.
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Budapest XHungaryCompleted
Belinus Bt.
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DebrecenHungaryCompleted
Borbanya Praxis Egeszsegugyi Kft
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NyíregyházaHungaryCompleted
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Ospedaliera Universitaria Mater Domini
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CatanzaroItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyCompleted
Renew Clinic Sp. z o.o.
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BialystokPolandCompleted
Osteo-Medic s.c. A. Racewicz, J. Supronik
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BialystokPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Centrum Medyczne Medyk Sp. z o.o.
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RzeszowPolandCompleted
Nbr Polska Tomasz Klodawski
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WarsawPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandCompleted
Velocity Nova Sp. z o.o.
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ZamośćPolandCompleted
Clinical hospital center Bezanijska Kosa
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BelgradeSerbiaUnknown status
Clinical Hospital Centre Zemun
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BelgradeSerbiaUnknown status
CHC Zvezdara, Clinical department for endocrinology
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BelgradeSerbiaUnknown status
Policlinic for diabetes
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ZaječarSerbiaUnknown status
King Abdulaziz Hospital-Al Ahsa-National Guard
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Al AhsaSaudi ArabiaUnknown status
National Guard Hospital - Jeddah
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JeddahSaudi ArabiaUnknown status
King Fahad Medical City
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RiyadhSaudi ArabiaUnknown status
King Salman Bin Abdulaziz Hospital
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RiyadhSaudi ArabiaUnknown status
King Khaled University Hospital,King Saud Univ. Med. City
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RiyadhSaudi ArabiaUnknown status
Amarillo Medical Specialists
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AmarilloUnited StatesUnknown status
Elligo Clin Res Centre
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AustinUnited StatesUnknown status
Brigham & Women's Hospital
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BostonUnited StatesUnknown status
Headlands Research - Brownsville
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BrownsvilleUnited StatesUnknown status
Velocity Clinical Res-Dallas
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DallasUnited StatesUnknown status
Encore Medical Research LLC
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HollywoodUnited StatesUnknown status
Nat Res Inst Huntington Park
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Huntington ParkUnited StatesUnknown status
Holston Medical Group.
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KingsportUnited StatesUnknown status
TPMG Clinical Research
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Newport NewsUnited StatesUnknown status
Alliance for Multispec Res
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NewtonUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Headlands Research Orlando
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OrlandoUnited StatesUnknown status
Summit Research Network Oregon Inc.
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PortlandUnited StatesUnknown status
Northeast Clinical Research of San Antonio
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San AntonioUnited StatesUnknown status
Southern California Dermatology
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Santa AnaUnited StatesUnknown status
Consano Clinical Research, LLC
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Shavano ParkUnited StatesUnknown status
Sugar Lakes Family Practice, PA
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Sugar LandUnited StatesUnknown status
Arcturus HC PLC Troy Med Res
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TroyUnited StatesUnknown status
Valley Diab. & Endo Comp Ctr
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WeslacoUnited StatesUnknown status
Encore Medical Research of Weston
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WestonUnited StatesUnknown status
Southgate Medical Group, LLP
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West SenecaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.