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HomeTrials › NCT06534411

Type 2 diabetes · Phase 3 · Active, not recruiting

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both

NCT06534411 · Sponsor: Novo Nordisk A/S

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Cagrilintide, Semaglutide, Tirzepatide for diabetes mellitus, type 2.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeCagrilintide, Semaglutide, Tirzepatide
Study length~19 months overall
Planned participants1,023
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: * Metformin * sodium-glucose co-transporter 2 inhibitor (SGLT2i) * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) \>= 30 kilogram 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. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * 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. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed. * 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study sites by state

Alabama

  • Cahaba Research — Pelham

Arizona

  • Velocity Clinical Research-Phoenix — Phoenix
  • AES Tucson DRS — Tucson

Arkansas

  • Woodland Int. Research Group — Little Rock

California

  • Velocity Clin Res-Chula Vista — Chula Vista
  • John Muir Physicians Network — Concord
  • Diabetes & Endocrine Specialists - La Mesa — La Mesa
  • Velocity Clin Research LA — Los Angeles
  • Desert Oasis Healthcare — Palm Springs
  • Velocity Clin Res Santa Ana — Santa Ana
  • Velocity Clin Res - Panorama — Van Nuys

Colorado

  • Optumcare Clinical Trials,LLC-Golden — Colorado Springs

District of Columbia

  • FEME Medical LLC — Washington D.C.

Florida

  • Tampa Bay Medical Research — Clearwater
  • AGA Clinical Trial — Hialeah
  • Bioclinical Research Alliance — Miami
  • New Horizon Research Center — Miami
  • South Broward Research LLC — Miramar
  • West Orange Endocrinology — Ocoee
  • Optimal Research Sites — Orange City
  • Center for Diab,Obes & Metab — Pembroke Pines

Georgia

  • Javara Inc. / Privia Medical Group Georgia LLC — Fayetteville

Illinois

  • Clinical Invest Special_Gurnee — Gurnee

Iowa

  • Iowa Diabetes & Endo Res Ctr — West Des Moines

Kansas

  • Cotton-Oneill Diabetes and End — Topeka

Minnesota

  • AES Minneapolis DRS — Richfield

Mississippi

  • Velocity Clin Res Gulfport — Gulfport

Missouri

  • AES St. Louis DRS — St Louis

Nebraska

  • Univ of Nebraska Medical CTR — Omaha

New Mexico

  • Velocity Clin Res Albuquerque — Albuquerque

New York

  • Albany Medical College — Albany

North Carolina

  • Carteret Medical Group — Morehead City
  • Piedmont Healthcare/Research — Statesville

North Dakota

  • Lillestol Research LLC — Fargo

Oklahoma

  • Triad Research Institute — Norman

Pennsylvania

  • Circuit Clinical - PMSI — Pottstown

Rhode Island

  • Clinical Res Collaborative — Cumberland
  • Velocity Clin Res Providence — East Greenwich

South Carolina

  • Velocity Clin Res Gaffney — Gaffney

Tennessee

  • Holston Medical Group — Kingsport
  • Clinical Research Associates — Nashville

Texas

  • Velocity Clin Res Austin — Austin
  • AES Dallas DFW DRS — Dallas
  • UT Southwestern Medical Center - Lingvay — Dallas
  • JCCT- Juno NW Houston — Houston
  • Discovery MM Services - Houston - Broadway Street — Houston
  • PlanIt Research, PLLC — Houston
  • Sante Clinical Research — Kerrville
  • Aeres Clinical Research — Laredo
  • RGV Endocrine Center — McAllen
  • Privia Health Javara Clin Res. — Stephenville

Utah

  • J.Lewis Research Inc — Salt Lake City
  • Chrysalis Clinical Research — St. George

Virginia

  • TPMG Clinical Research — Newport News

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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