Recruiting

Phase 3

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

Sponsor:

Novo Nordisk A/S

Code:

NCT07817251

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CagriSema

Study Details

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07817251

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Jul 21, 2027

Anticipated

Primary completion date

Jun 9, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CagriSema dose 1

Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.

experimental: CagriSema dose 2

Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1.

experimental: CagriSema dose 3

Participants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1.

Interventions

CagriSema

CagriSema will be administered s.c. once weekly.

Primary outcome measure

Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (Week 0) to end of treatment (Week 16) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Gilbert Center For Family Medicine

Recruiting

Gilbert, Arizona, United States, 85296

Ark Clinical Research

Recruiting

Fountain Valley, California, United States, 92708

Thrive Clinical Research Group

Recruiting

Glendora, California, United States, 91740

Scripps Whittier Diabetes Inst

Recruiting

La Jolla, California, United States, 92037

Downtown LA Res Ctr. Inc.

Recruiting

Los Angeles, California, United States, 90017

Valley Clinical Trials, Inc.

Recruiting

Northridge, California, United States, 91325

Dream Team Clinical Research

Recruiting

Pomona, California, United States, 91767

Clinical Trials Research_Sacramento

Recruiting

Sacramento, California, United States, 95821

Linda Vista Health Care Ctr

Recruiting

San Diego, California, United States, 92111

Chase Medical Research LLC

Recruiting

Waterbury, Connecticut, United States, 06708

Northeast Research Institute

Recruiting

Fleming Island, Florida, United States, 32003

AGA Clinical Trial

Recruiting

Hialeah, Florida, United States, 33012

Adult Medicine of Lake County, Inc

Recruiting

Mt. Dora, Florida, United States, 32757

Optimal Research Sites

Recruiting

Orange City, Florida, United States, 32763

Metabolic Research Institute Inc

Recruiting

West Palm Beach, Florida, United States, 33401

East West Med Res Inst

Recruiting

Honolulu, Hawaii, United States, 96814

Endeavor Health

Recruiting

Skokie, Illinois, United States, 60077

Iowa Diabetes & Endo Res Ctr

Recruiting

West Des Moines, Iowa, United States, 50266

Alliance for Multispecialty Research

Recruiting

Newton, Kansas, United States, 67114

Cotton O'Neil Diabetes & Endocrinology

Recruiting

Topeka, Kansas, United States, 66606

Northern Pines Hlth Ctr, PC

Recruiting

Buckley, Michigan, United States, 49620

Palm Research Center Inc-Vegas

Recruiting

Las Vegas, Nevada, United States, 89128

Albuquerque Clinical Trials Inc.

Recruiting

Albuquerque, New Mexico, United States, 87102

PharmQuest Life Sciences LLC

Recruiting

Greensboro, North Carolina, United States, 27408

Accellacare Wilmington

Recruiting

Wilmington, North Carolina, United States, 28401

Clinical Research Associates

Recruiting

Nashville, Tennessee, United States, 37203

Amarillo Med Spec LLP

Recruiting

Amarillo, Texas, United States, 79124

Texas Diabetes & Endocrinology

Recruiting

Austin, Texas, United States, 78749

North Texas Endocrine Center

Recruiting

Dallas, Texas, United States, 75231

Diabetes and Thyroid Center of Fort Worth

Recruiting

Fort Worth, Texas, United States, 76132

JCCT- Juno NW Houston

Recruiting

Houston, Texas, United States, 77040

Sante Clinical Research

Recruiting

Kerrville, Texas, United States, 78028

DCOL Ctr for Clin Res

Recruiting

Longview, Texas, United States, 75605

North Hills Medical Research Inc

Recruiting

North Richland Hills, Texas, United States, 76180

J.Lewis Research Inc

Recruiting

Salt Lake City, Utah, United States, 84109

Chrysalis Clinical Research

Recruiting

St. George, Utah, United States, 84790

Tidewater Physicians Multispecialty Group

Recruiting

Newport News, Virginia, United States, 23606

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.