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Diabetes Mellitus, Type 2Phase 3NCT07817251

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

A Phase 3 study testing CagriSema in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 40 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
CagriSema
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
40 sitesUnited States
Study dates
16 Sep 2026to 21 Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

40 sites in 1 country

United States40 sites, 40 recruiting

  • Albuquerque Clinical Trials Inc.

    Albuquerque, New Mexico, 87102

    Recruiting

  • Amarillo Med Spec LLP

    Amarillo, Texas, 79124

    Recruiting

  • Texas Diabetes & Endocrinology

    Austin, Texas, 78749

    Recruiting

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

    Recruiting

  • North Texas Endocrine Center

    Dallas, Texas, 75231

    Recruiting

  • Northeast Research Institute

    Fleming Island, Florida, 32003

    Recruiting

  • Diabetes and Thyroid Center of Fort Worth

    Fort Worth, Texas, 76132

    Recruiting

  • Ark Clinical Research

    Fountain Valley, California, 92708

    Recruiting

  • Gilbert Center For Family Medicine

    Gilbert, Arizona, 85296

    Recruiting

  • Thrive Clinical Research Group

    Glendora, California, 91740

    Recruiting

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

    Recruiting

  • AGA Clinical Trial

    Hialeah, Florida, 33012

    Recruiting

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

    Recruiting

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

    Recruiting

  • Sante Clinical Research

    Kerrville, Texas, 78028

    Recruiting

  • Scripps Whittier Diabetes Inst

    La Jolla, California, 92037

    Recruiting

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89128

    Recruiting

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

    Recruiting

  • Downtown LA Res Ctr. Inc.

    Los Angeles, California, 90017

    Recruiting

  • Advanced Medical Research

    Maumee, Ohio, 43537

    Not yet recruiting

  • Adult Medicine of Lake County, Inc

    Mt. Dora, Florida, 32757

    Recruiting

  • Clinical Research Associates

    Nashville, Tennessee, 37203

    Recruiting

  • Tidewater Physicians Multispecialty Group

    Newport News, Virginia, 23606

    Recruiting

  • Alliance for Multispecialty Research

    Newton, Kansas, 67114

    Recruiting

  • North Hills Medical Research Inc

    North Richland Hills, Texas, 76180

    Recruiting

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

    Recruiting

  • Optimal Research Sites

    Orange City, Florida, 32763

    Recruiting

  • Dream Team Clinical Research

    Pomona, California, 91767

    Recruiting

  • Clinical Trials Research_Sacramento

    Sacramento, California, 95821

    Recruiting

  • J.Lewis Research Inc

    Salt Lake City, Utah, 84109

    Recruiting

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

    Not yet recruiting

  • Linda Vista Health Care Ctr

    San Diego, California, 92111

    Recruiting

  • Diabetes & Endo Treatment Spec

    Sandy City, Utah, 84093

    Not yet recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Chrysalis Clinical Research

    St. George, Utah, 84790

    Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

    Recruiting

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

    Recruiting

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266

    Recruiting

  • Metabolic Research Institute Inc

    West Palm Beach, Florida, 33401

    Recruiting

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
CagriSema
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagriSemaDrug

    CagriSema will be administered s.c. once weekly.

Study groups in NCT07817251
Study groupRoleWhat they receive
CagriSema dose 1ExperimentalParticipants previously treated with once-weekly semaglutide subcutaneously (s.c.) will switch to once-weekly CagriSema dose 1.
Receives: Drug: CagriSema
CagriSema dose 2ExperimentalParticipants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 2, followed by dose 1.
Receives: Drug: CagriSema
CagriSema dose 3ExperimentalParticipants previously treated with once-weekly semaglutide s.c. will switch to once-weekly CagriSema dose 3, followed by dose 2 and dose 1.
Receives: Drug: CagriSema

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of treatment emergent adverse events (TEAEs)

    Measured as count of events.

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

Secondary outcomes (7)

  1. Number of TEAEs

    Measured as count of events.

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

  2. Number of TEAEs

    Measured as count of events.

    Measured: From baseline (Week 0) to Week 8

  3. 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)

    Measured as count of episodes.

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

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

    Measured as count of episodes.

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

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

    Measured as count of episodes.

    Measured: From baseline (Week 0) to Week 8

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

    Measured as count of episodes.

    Measured: From baseline (Week 0) to Week 8

  7. Number of participants who discontinued due to gastrointestinal (GI) adverse events (AEs)

    Measured as count of participants.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2026
  2. Study start16 Sep 2026
  3. Primary completion9 Jun 2027 (estimated)
  4. Study completion21 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07817251
Sponsor's protocol ID
NN9388-8593
Other IDs
U1111-1332-8482
Status last verified
Sep 2026
First submitted
8 Sep 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CagriSema in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events (TEAEs) (time frame: From baseline (Week 0) to end of treatment (Week 16)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07817251.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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