REIMAGINE 2: A research study to see how well CagriSema compared to semaglutide, cagrilintide and placebo lowers blood sugar and body weight in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitor

Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor(NN9388-4896) - REIMAGINE2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230369

Enrollment

2700

Registered

2023-09-27

Start date

2023-09-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Participants with T2D will be randomised to receive either: -CagriSema 2.4 mg/2.4 mg -CagriSema 1.0 mg/1.0 mg -Semaglutide 2.4 mg -Semaglutide 1.0 mg -Cagrilintide 2.4 mg -Placebo 2.4 mg/2.4 mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Male or female. -Age 18 years or above at the time of signing the informed consent. -Diagnosed with type 2 diabetes mellitus >= 180 days before screening. -Stable daily dose(s) >= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitors. -HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening. -BMI >=25 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening.

Exclusion criteria

Exclusion criteria: -Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 m2 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 a fundus examination performed within 90 days before screening or in the period between screening and randomisation.

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline (week 0) to end of treatment (week 68)	—

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Poland, Romania, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom

Contacts

Public ContactRyoma Hirose

Novo Nordisk Pharma Ltd.

jphc_clinical_trials@novonordisk.com+81-362661000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026