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

September 8, 2026 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Gilbert Center For Family Medicine
    • California
      • Fountain Valley, California, United States, 92708
        • Ark Clinical Research
      • Glendora, California, United States, 91740
        • Thrive Clinical Research Group
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Inst
      • Los Angeles, California, United States, 90017
        • Downtown LA Res Ctr. Inc.
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Pomona, California, United States, 91767
        • Dream Team Clinical Research
      • Sacramento, California, United States, 95821
        • Clinical Trials Research_Sacramento
      • San Diego, California, United States, 92111
        • Linda Vista Health Care Ctr
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Northeast Research Institute
      • Hialeah, Florida, United States, 33012
        • AGA Clinical Trial
      • Mt. Dora, Florida, United States, 32757
        • Adult Medicine of Lake County, Inc
      • Orange City, Florida, United States, 32763
        • Optimal Research Sites
      • West Palm Beach, Florida, United States, 33401
        • Metabolic Research Institute Inc
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East West Med Res Inst
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Diabetes & Endo Res Ctr
    • Kansas
      • Newton, Kansas, United States, 67114
        • Alliance for Multispecialty Research
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Northern Pines Hlth Ctr, PC
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Inc-Vegas
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials Inc.
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest Life Sciences LLC
      • Wilmington, North Carolina, United States, 28401
        • Accellacare Wilmington
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Advanced Medical Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Fort Worth, Texas, United States, 76132
        • Diabetes and Thyroid Center of Fort Worth
      • Houston, Texas, United States, 77040
        • JCCT- Juno NW Houston
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research
      • Longview, Texas, United States, 75605
        • DCOL Ctr for Clin Res
      • North Richland Hills, Texas, United States, 76180
        • North Hills Medical Research Inc
      • San Antonio, Texas, United States, 78233
        • NE Clin Res of San Antonio
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • J.Lewis Research Inc
      • Sandy City, Utah, United States, 84093
        • Diabetes & Endo Treatment Spec
      • St. George, Utah, United States, 84790
        • Chrysalis Clinical Research
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Tidewater Physicians Multispecialty Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CagriSema dose 1
Participants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.
Drug: CagriSema
CagriSema will be administered s.c. once weekly.
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.
Drug: CagriSema
CagriSema will be administered s.c. once weekly.
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.
Drug: CagriSema
CagriSema will be administered s.c. once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment emergent adverse events (TEAEs)
Time Frame: From baseline (Week 0) to end of treatment (Week 16)
Measured as count of events.
From baseline (Week 0) to end of treatment (Week 16)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of TEAEs
Time Frame: From baseline (Week 0) to end of study (Week 22)
Measured as count of events.
From baseline (Week 0) to end of study (Week 22)
Number of TEAEs
Time Frame: From baseline (Week 0) to Week 8
Measured as count of events.
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)
Time Frame: From baseline (Week 0) to end of study (Week 22)
Measured as count of episodes.
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
Time Frame: From baseline (Week 0) to end of study (Week 22)
Measured as count of episodes.
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)
Time Frame: From baseline (Week 0) to Week 8
Measured as count of episodes.
From baseline (Week 0) to Week 8
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Time Frame: From baseline (Week 0) to Week 8
Measured as count of episodes.
From baseline (Week 0) to Week 8
Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs)
Time Frame: From baseline (Week 0) to end of treatment (Week 16)
Measured as count of participants.
From baseline (Week 0) to end of treatment (Week 16)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 16, 2026

Primary Completion (Estimated)

June 9, 2027

Study Completion (Estimated)

July 21, 2027

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9388-8593
  • U1111-1332-8482 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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