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Recruiting Phase 3

Research Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema

NCT07817251 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-09-16
Last updated
2026-09-30

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

CagriSema →

CagriSema: CagriSema will be administered s.c. once weekly.

Study summary

The purpose of this clinical study is to look at the safety and tolerability of switching from semaglutide to CagriSema, for participants who have type 2 diabetes. All participants will get CagriSema, the treatment being tested. Participants will be in this clinical study for about 6 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus (T2DM) greater than or equal to (≥) 180 days before screening. * Stable once-weekly dose ≥ 90 days before screening of branded s.c. semaglutide. Branded semaglutide s.c. includes Ozempic and Wegovy. Participants on compounded semaglutide are ineligible. * Not on treatment with oral antidiabetic drugs or on stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen at effective or maximum tolerated dose (MTD) as judged by the investigator: metformin and/or sodiumglucose co-transporter-2 (SGLT2) inhibitor. * Glycated haemoglobin (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) ≥ 25 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. 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 from screening. * Renal impairment with estimated glomerular filtration rate (eGFR) 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 medication for the indication of diabetes or obesity other than stated in the inclusion criteria 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. * 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. * A self-reported change in body weight \> 5% within 90 days before screening irrespective of medical records. * Use of personal continuous glucose monitoring (CGM) devices. Participants currently using personal CGM devices must discontinue use prior to screening and throughout study participation.

Primary outcome measure(s)

  • Number of treatment emergent adverse events (TEAEs) — From baseline (Week 0) to end of treatment (Week 16)
    Measured as count of events.

Trial sites (40)

FacilityCityRegionStatus
Gilbert Center For Family Medicine Gilbert Arizona Recruiting
Ark Clinical Research Fountain Valley California Recruiting
Thrive Clinical Research Group Glendora California Recruiting
Scripps Whittier Diabetes Inst La Jolla California Recruiting
Downtown LA Res Ctr. Inc. Los Angeles California Recruiting
Valley Clinical Trials, Inc. Northridge California Recruiting
Dream Team Clinical Research Pomona California Recruiting
Clinical Trials Research_Sacramento Sacramento California Recruiting
Linda Vista Health Care Ctr San Diego California Recruiting
Chase Medical Research LLC Waterbury Connecticut Recruiting
Northeast Research Institute Fleming Island Florida Recruiting
AGA Clinical Trial Hialeah Florida Recruiting
Adult Medicine of Lake County, Inc Mt. Dora Florida Recruiting
Optimal Research Sites Orange City Florida Recruiting
Metabolic Research Institute Inc West Palm Beach Florida Recruiting
East West Med Res Inst Honolulu Hawaii Recruiting
Endeavor Health Skokie Illinois Recruiting
Iowa Diabetes & Endo Res Ctr West Des Moines Iowa Recruiting
Alliance for Multispecialty Research Newton Kansas Recruiting
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas Recruiting
Northern Pines Hlth Ctr, PC Buckley Michigan Recruiting
Palm Research Center Inc-Vegas Las Vegas Nevada Recruiting
Albuquerque Clinical Trials Inc. Albuquerque New Mexico Recruiting
PharmQuest Life Sciences LLC Greensboro North Carolina Recruiting
Accellacare Wilmington Wilmington North Carolina Recruiting
Advanced Medical Research Maumee Ohio Not Yet Recruiting
Clinical Research Associates Nashville Tennessee Recruiting
Amarillo Med Spec LLP Amarillo Texas Recruiting
Texas Diabetes & Endocrinology Austin Texas Recruiting
North Texas Endocrine Center Dallas Texas Recruiting
Diabetes and Thyroid Center of Fort Worth Fort Worth Texas Recruiting
JCCT- Juno NW Houston Houston Texas Recruiting
Sante Clinical Research Kerrville Texas Recruiting
DCOL Ctr for Clin Res Longview Texas Recruiting
North Hills Medical Research Inc North Richland Hills Texas Recruiting
NE Clin Res of San Antonio San Antonio Texas Not Yet Recruiting
J.Lewis Research Inc Salt Lake City Utah Recruiting
Diabetes & Endo Treatment Spec Sandy City Utah Not Yet Recruiting
Chrysalis Clinical Research St. George Utah Recruiting
Tidewater Physicians Multispecialty Group Newport News Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07817251 on ClinicalTrials.gov ↗ ← All trials in the USA