ClinicalTrials.gg
RecruitingNCT07817251Updated Sep 30, 2026

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

A Phase 3 interventional study of CagriSema in Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Recruiting at 40 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 30, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies testing cagrilintide in Diabetes Mellitus, Type 2 — 3 open to participants now, 4 under way, 4 of them phase 3. cagrilintide · Diabetes Mellitus, Type 2.

Planned enrollment
9th of 15
210 · median 274
Started
2026
with 3 others
Phase 3
10 of 15
3 open now
Registered
15th of 15
by date
Lead sponsor
15 of 15
Novo Nordisk A/S

Among the 15 studies testing cagrilintide in Diabetes Mellitus, Type 2, this one is the 9th largest by planned enrollment, is one of 4 that started in 2026, is one of 10 in phase 3, and was the 15th registered.

How this study gives cagrilintide

On this site’s reading of the record, cagrilintide is the treatment under test here. Read study by study →

By phase

15 studies; the count open now beside each. This study's row is marked.

Phase 3this study10 · 3 open
Phase 24 · 0 open
Phase 11 · 0 open

By the year they started

First in 2021; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 274 across the 15 interventional studies. Of the 10 that completed or were terminated, 1 (10%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 15 studies testing cagrilintide in Diabetes Mellitus, Type 2, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Diabetes Mellitus, Type 2
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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.
  • (HbA1c) 6.5-10.5 percentage (%) (48-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
  • (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

Exclusion criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of and not using a highly effective method from screening.
  • Renal impairment with estimated (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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    CagriSema dose 1

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

    Drug: CagriSema

  • 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

  • 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

Interventions

  • CagriSema will be administered s.c. once weekly.

This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Measured as count of events.

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

Secondary outcomes

  1. Number of TEAEs

    Measured as count of events.

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

  2. Number of TEAEs

    Measured as count of events.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

37 of 40 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.

Of 438 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's planned 8 months is below that.

Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartActual
Sep 16, 2026
Primary completionEst.
Jun 9, 2027
CompletionEst.
Jul 21, 2027
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 30, 2026
Sites
40 sites changed recruiting status (37 now recruiting, 3 now not yet recruiting)
Show 40 sites
  • Gilbert Center For Family Medicine · Gilbert, United Statesno status→Recruiting
  • Ark Clinical Research · Fountain Valley, United Statesno status→Recruiting
  • Thrive Clinical Research Group · Glendora, United Statesno status→Recruiting
  • Scripps Whittier Diabetes Inst · La Jolla, United Statesno status→Recruiting
  • Downtown LA Res Ctr. Inc. · Los Angeles, United Statesno status→Recruiting
  • Valley Clinical Trials, Inc. · Northridge, United Statesno status→Recruiting
  • Dream Team Clinical Research · Pomona, United Statesno status→Recruiting
  • Clinical Trials Research_Sacramento · Sacramento, United Statesno status→Recruiting
  • Linda Vista Health Care Ctr · San Diego, United Statesno status→Recruiting
  • Chase Medical Research LLC · Waterbury, United Statesno status→Recruiting
  • Northeast Research Institute · Fleming Island, United Statesno status→Recruiting
  • AGA Clinical Trial · Hialeah, United Statesno status→Recruiting
  • Adult Medicine of Lake County, Inc · Mt. Dora, United Statesno status→Recruiting
  • Optimal Research Sites · Orange City, United Statesno status→Recruiting
  • Metabolic Research Institute Inc · West Palm Beach, United Statesno status→Recruiting
  • East West Med Res Inst · Honolulu, United Statesno status→Recruiting
  • Endeavor Health · Skokie, United Statesno status→Recruiting
  • Iowa Diabetes & Endo Res Ctr · West Des Moines, United Statesno status→Recruiting
  • Alliance for Multispecialty Research · Newton, United Statesno status→Recruiting
  • Cotton O'Neil Diabetes & Endocrinology · Topeka, United Statesno status→Recruiting
  • Northern Pines Hlth Ctr, PC · Buckley, United Statesno status→Recruiting
  • Palm Research Center Inc-Vegas · Las Vegas, United Statesno status→Recruiting
  • Albuquerque Clinical Trials Inc. · Albuquerque, United Statesno status→Recruiting
  • PharmQuest Life Sciences LLC · Greensboro, United Statesno status→Recruiting
  • Accellacare Wilmington · Wilmington, United Statesno status→Recruiting
  • Advanced Medical Research · Maumee, United Statesno status→Not yet recruiting
  • Clinical Research Associates · Nashville, United Statesno status→Recruiting
  • Amarillo Med Spec LLP · Amarillo, United Statesno status→Recruiting
  • Texas Diabetes & Endocrinology · Austin, United Statesno status→Recruiting
  • North Texas Endocrine Center · Dallas, United Statesno status→Recruiting
  • …and 10 more on the registry record
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Not yet recruiting→Recruiting
    40 sites changed recruiting status (37 now recruiting, 3 now not yet recruiting)
    Show 40 sites
    • Gilbert Center For Family Medicine · Gilbert, United Statesno status→Recruiting
    • Ark Clinical Research · Fountain Valley, United Statesno status→Recruiting
    • Thrive Clinical Research Group · Glendora, United Statesno status→Recruiting
    • Scripps Whittier Diabetes Inst · La Jolla, United Statesno status→Recruiting
    • Downtown LA Res Ctr. Inc. · Los Angeles, United Statesno status→Recruiting
    • Valley Clinical Trials, Inc. · Northridge, United Statesno status→Recruiting
    • Dream Team Clinical Research · Pomona, United Statesno status→Recruiting
    • Clinical Trials Research_Sacramento · Sacramento, United Statesno status→Recruiting
    • Linda Vista Health Care Ctr · San Diego, United Statesno status→Recruiting
    • Chase Medical Research LLC · Waterbury, United Statesno status→Recruiting
    • Northeast Research Institute · Fleming Island, United Statesno status→Recruiting
    • AGA Clinical Trial · Hialeah, United Statesno status→Recruiting
    • Adult Medicine of Lake County, Inc · Mt. Dora, United Statesno status→Recruiting
    • Optimal Research Sites · Orange City, United Statesno status→Recruiting
    • Metabolic Research Institute Inc · West Palm Beach, United Statesno status→Recruiting
    • East West Med Res Inst · Honolulu, United Statesno status→Recruiting
    • Endeavor Health · Skokie, United Statesno status→Recruiting
    • Iowa Diabetes & Endo Res Ctr · West Des Moines, United Statesno status→Recruiting
    • Alliance for Multispecialty Research · Newton, United Statesno status→Recruiting
    • Cotton O'Neil Diabetes & Endocrinology · Topeka, United Statesno status→Recruiting
    • Northern Pines Hlth Ctr, PC · Buckley, United Statesno status→Recruiting
    • Palm Research Center Inc-Vegas · Las Vegas, United Statesno status→Recruiting
    • Albuquerque Clinical Trials Inc. · Albuquerque, United Statesno status→Recruiting
    • PharmQuest Life Sciences LLC · Greensboro, United Statesno status→Recruiting
    • Accellacare Wilmington · Wilmington, United Statesno status→Recruiting
    • Advanced Medical Research · Maumee, United Statesno status→Not yet recruiting
    • Clinical Research Associates · Nashville, United Statesno status→Recruiting
    • Amarillo Med Spec LLP · Amarillo, United Statesno status→Recruiting
    • Texas Diabetes & Endocrinology · Austin, United Statesno status→Recruiting
    • North Texas Endocrine Center · Dallas, United Statesno status→Recruiting
    • …and 10 more on the registry record
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07817251
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 14, 2026
Start date
Sep 16, 2026
Primary completion
Jun 9, 2027 (estimated)
Completion
Jul 21, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Cagrilintide

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