RecruitingPhase 3

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

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

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

210

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≥25•HbA1c 6.5-10.5%

Primary endpoint

•Number of treatment emergent adverse events (TEAEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07817251

Org study IDNN9388-8593

Secondary IDU1111-1332-8482World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-09-14actual

Study start2026-09-16actual

Last update posted2026-09-30actual

Primary completion2027-06-09estimated

Study completion2027-07-21estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot 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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

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)

event count, event

Secondary/protocol endpoint

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)

event count, event

Secondary/protocol endpoint

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

event count, event

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

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

event count, event

Secondary/protocol endpoint

Number of TEAEs

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

event count, event

Secondary/protocol endpoint

Number of TEAEs

Time frame:From baseline (Week 0) to Week 8

event count, event

Secondary/protocol endpoint

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

event count, event

Secondary/protocol endpoint

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

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

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.