REIMAGINE 1

CompletedPhase 3

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4 mg/2.4 mg and 1.0 mg/1.0 mg Once Weekly Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Diet and Exercise

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

189

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7-9.5%

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 IDNCT06323174

Org study IDNN9388-4895

Secondary ID2022-502677-42European Medical Agency (EMA)

Secondary IDU1111-1283-0404World Health Organization (WHO)

Timeline

Milestones

Study start2024-03-19actual

Study first posted2024-03-21actual

Primary completion2025-10-01actual

Study completion2025-12-22actual

Last update posted2026-04-02actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female

•Age 18 years or above at the time of signing the informed consent

•Diagnosed with type 2 diabetes >=30 days before screening

•HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening

•Body mass index (BMI) >=23 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

•Renal impairment with estimated Glomerular Filtration Rate 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 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

•History of use of any injectable therapy for diabetes or obesity. 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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Endpoints (31)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

6 endpoints

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 40)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of participants who achieve greater than or equal to (>=) 10% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 40)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve >=15% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 40)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve >=5% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 40)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieve >=20% body weight reduction

Time frame:From baseline (week 0) to end of treatment (week 40)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 40)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 40)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

Time frame:At end of treatment (week 40)

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol)

Time frame:At end of treatment (week 40)

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:From baseline (week 0) to end of treatment (week 40)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication)

Time frame:At end of study (week 52)

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo)

Time frame:From baseline (week 0) to end of treatment (week 40)

ratio, improvement

Cardiometabolic biomarkers

12 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 40)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure (DBP)

Time frame:From baseline (week 0) to end of treatment (week 40)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Ratio to baseline in high sensitivity C-reactive protein (hsCRP)

Time frame:From baseline (week 0) to end of treatment (week 40)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio to baseline in lipids: Total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 40)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 40)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 40)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 40)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 40)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in lipids: Free fatty acids

Time frame:From baseline (week 0) to end of treatment (week 40)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: Non-HDL cholesterol

Time frame:From baseline (week 0) to end of treatment (week 40)

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in leptin

Time frame:From baseline (week 0) to end of treatment (week 40)

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Change in soluble leptin receptor

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score

Time frame:From baseline (week 0) to end of treatment (week 40)

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 score: Physical Component Summary score

Time frame:From baseline (week 0) to end of treatment (week 40)

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36v2 score: Mental Component Summary score

Time frame:From baseline (week 0) to end of treatment (week 40)

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

Time frame:From baseline (week 0) to end of treatment (week 40)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of treatment +7 weeks (week 47)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter

Time frame:From baseline (week 0) to end of treatment +7 weeks (week 47)

Documented hypoglycemia

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 treatment + 7 weeks (week 47)

Severe hypoglycemia

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Aroda VR, Buzzetti R, Dalskov SM, Jain AB, Larsen JH, Mathieu C, Pratley RE, Videmark A, Watt T, Buse JB. Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study. Lancet Diabetes Endocrinol. 2026 Jun 7:S2213-8587(26)00126-9. doi: 10.1016/S2213-8587(26)00126-9. Online ahead of print.
PMID42251860via clinicaltrials gov reference derived

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.