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NCT07817251

PHASE3

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: Safety And Tolerability of 3 Switch Regimens From Semaglutide 1.0 mg and 2.0 mg to Co-Administered Cagrilintide and Semaglutide (Cagrisema) in Participants With Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-09-16

Completion Date

2027-07-21

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG

CagriSema

CagriSema will be administered s.c. once weekly.

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.

Locations (40)

Gilbert Center For Family Medicine

Gilbert, Arizona, United States

Ark Clinical Research

Fountain Valley, California, United States

Thrive Clinical Research Group

Glendora, California, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Downtown LA Res Ctr. Inc.

Los Angeles, California, United States

Valley Clinical Trials, Inc.

Northridge, California, United States

Dream Team Clinical Research

Pomona, California, United States

Clinical Trials Research_Sacramento

Sacramento, California, United States

Linda Vista Health Care Ctr

San Diego, California, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Northeast Research Institute

Fleming Island, Florida, United States

AGA Clinical Trial

Hialeah, Florida, United States

Adult Medicine of Lake County, Inc

Mt. Dora, Florida, United States

Optimal Research Sites

Orange City, Florida, United States

Metabolic Research Institute Inc

West Palm Beach, Florida, United States

East West Med Res Inst

Honolulu, Hawaii, United States

Endeavor Health

Skokie, Illinois, United States

Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, United States

Alliance for Multispecialty Research

Newton, Kansas, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Northern Pines Hlth Ctr, PC

Buckley, Michigan, United States

Palm Research Center Inc-Vegas

Las Vegas, Nevada, United States

Albuquerque Clinical Trials Inc.

Albuquerque, New Mexico, United States

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Accellacare Wilmington

Wilmington, North Carolina, United States

Advanced Medical Research

Maumee, Ohio, United States

Clinical Research Associates

Nashville, Tennessee, United States

Amarillo Med Spec LLP

Amarillo, Texas, United States

Texas Diabetes & Endocrinology

Austin, Texas, United States

North Texas Endocrine Center

Dallas, Texas, United States

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, United States

JCCT- Juno NW Houston

Houston, Texas, United States

Sante Clinical Research

Kerrville, Texas, United States

DCOL Ctr for Clin Res

Longview, Texas, United States

North Hills Medical Research Inc

North Richland Hills, Texas, United States

NE Clin Res of San Antonio

San Antonio, Texas, United States

J.Lewis Research Inc

Salt Lake City, Utah, United States

Diabetes & Endo Treatment Spec

Sandy City, Utah, United States

Chrysalis Clinical Research

St. George, Utah, United States

Tidewater Physicians Multispecialty Group

Newport News, Virginia, United States