GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT07357740

Not yet recruitingPhase 2

A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes

A Phase 2 Study to Compare Two Presentations of CagriSema in Participants With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

400

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-39.9•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07357740

Org study IDNN9388-8468

Secondary ID2025-522570-37European Medical Agency (EMA)

Secondary IDU1111-1323-3766World Health Organization (WHO)

Timeline

Milestones

Study first posted2026-01-22actual

Last update posted2026-03-30actual

Study start2026-08-27estimated

Primary completion2027-08-25estimated

Study completion2027-10-13estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female (sex assigned at birth, inclusive of all gender identities).

•Age 18-64 years (both inclusive) at the time of signing the informed consent.

•Diagnosed with type 2 diabetes mellitus greater than or equal to (>=) 180 days before screening.

•Glycated haemoglobin (HbA1c) 7.0-10.5 percent (%) (53-91 [millimoles per mole] mmol/mol) (both inclusive) as determined by the central laboratory at screening.

•Stable daily dose >= 90 days before screening of metformin at effective or maximum tolerated dose as judged by the investigator.

•Body mass index (BMI) between 25.0 and 39.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion criteria

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by the central laboratory at screening.

•Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before 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.

•Previous exposure to CagriSema in a clinical study.

Endpoints (5)

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

2 endpoints

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:Baseline to week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c

Time frame:From baseline to week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Weekly average cagrilintide (total) and semaglutide concentration (Cavg) based on population pharmacokinetic analyses

Time frame:From baseline to week 28

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline to week 35

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimoles per litre [mmol/L]), confirmed by blood glucose (BG) meter, or severe hypoglycaemic episodes (level 3)

Time frame:From baseline to week 35

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 July 1, 2026 snapshot.