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

NCT07817251 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: NN9388-8593U1111-1332-8482
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 40

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs)

  Measured as count of events.

  From baseline (Week 0) to end of treatment (Week 16)

Secondary Outcomes (7)

• Number of TEAEs

  From baseline (Week 0) to end of study (Week 22)

• Number of TEAEs

  From baseline (Week 0) to Week 8

• Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per liter [mmol/L] (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose [BG] meter)

  From baseline (Week 0) to end of study (Week 22)

• Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

  From baseline (Week 0) to end of study (Week 22)

• Number of clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)

  From baseline (Week 0) to Week 8

Study Arms (3)

CagriSema dose 1

EXPERIMENTAL

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

Drug: CagriSema

CagriSema dose 2

EXPERIMENTAL

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

Drug: CagriSema

CagriSema dose 3

EXPERIMENTAL

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

Drug: CagriSema

Interventions

CagriSema DRUG

CagriSema will be administered s.c. once weekly.

CagriSema dose 1; CagriSema dose 2; CagriSema dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (40)

Gilbert Center For Family Medicine

Gilbert, Arizona, 85296, United States

RECRUITING

Ark Clinical Research

Fountain Valley, California, 92708, United States

RECRUITING

Thrive Clinical Research Group

Glendora, California, 91740, United States

RECRUITING

Scripps Whittier Diabetes Inst

La Jolla, California, 92037, United States

RECRUITING

Downtown LA Res Ctr. Inc.

Los Angeles, California, 90017, United States

RECRUITING

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

RECRUITING

Dream Team Clinical Research

Pomona, California, 91767, United States

RECRUITING

Clinical Trials Research_Sacramento

Sacramento, California, 95821, United States

RECRUITING

Linda Vista Health Care Ctr

San Diego, California, 92111, United States

RECRUITING

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

RECRUITING

Northeast Research Institute

Fleming Island, Florida, 32003, United States

RECRUITING

AGA Clinical Trial

Hialeah, Florida, 33012, United States

RECRUITING

Adult Medicine of Lake County, Inc

Mt. Dora, Florida, 32757, United States

RECRUITING

Optimal Research Sites

Orange City, Florida, 32763, United States

RECRUITING

Metabolic Research Institute Inc

West Palm Beach, Florida, 33401, United States

RECRUITING

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

RECRUITING

Endeavor Health

Skokie, Illinois, 60077, United States

RECRUITING

Iowa Diabetes & Endo Res Ctr

West Des Moines, Iowa, 50266, United States

RECRUITING

Alliance for Multispecialty Research

Newton, Kansas, 67114, United States

RECRUITING

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

RECRUITING

Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States

RECRUITING

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89128, United States

RECRUITING

Albuquerque Clinical Trials Inc.

Albuquerque, New Mexico, 87102, United States

RECRUITING

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

RECRUITING

Accellacare Wilmington

Wilmington, North Carolina, 28401, United States

RECRUITING

Advanced Medical Research

Maumee, Ohio, 43537, United States

NOT YET RECRUITING

Clinical Research Associates

Nashville, Tennessee, 37203, United States

RECRUITING

Amarillo Med Spec LLP

Amarillo, Texas, 79124, United States

RECRUITING

Texas Diabetes & Endocrinology

Austin, Texas, 78749, United States

RECRUITING

North Texas Endocrine Center

Dallas, Texas, 75231, United States

RECRUITING

Diabetes and Thyroid Center of Fort Worth

Fort Worth, Texas, 76132, United States

RECRUITING

JCCT- Juno NW Houston

Houston, Texas, 77040, United States

RECRUITING

Sante Clinical Research

Kerrville, Texas, 78028, United States

RECRUITING

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

RECRUITING

North Hills Medical Research Inc

North Richland Hills, Texas, 76180, United States

RECRUITING

NE Clin Res of San Antonio

San Antonio, Texas, 78233, United States

NOT YET RECRUITING

J.Lewis Research Inc

Salt Lake City, Utah, 84109, United States

RECRUITING

Diabetes & Endo Treatment Spec

Sandy City, Utah, 84093, United States

NOT YET RECRUITING

Chrysalis Clinical Research

St. George, Utah, 84790, United States

RECRUITING

Tidewater Physicians Multispecialty Group

Newport News, Virginia, 23606, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded during the treatment switch period, followed by an open-label dose-maintenance period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): July 21, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (40)