GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes

Effect of CagriSema, Semaglutide and Cagrilintide on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

158

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-45•Established CVD•HbA1c 6.5-9.5%

Primary endpoint

•Effect of CagriSema

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 IDNCT06403761

Org study IDNN9388-7782

Secondary ID2023-509483-20European Medical Agency (EMA)

Secondary IDU1111-1300-1930World Health Organization (WHO)

Timeline

Milestones

Study start2024-05-06actual

Study first posted2024-05-08actual

Primary completion2025-12-28actual

Study completion2026-02-02actual

Last update posted2026-02-27actual

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female.

•Aged 18-75 years (both inclusive) at the time of signing informed consent.

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

•Stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for 90 or more days before screening with or without one additional oral antidiabetic drug (OAD), except for the use of glucagon-like peptide-1 (GLP-1) receptor agonists, or sodium-glucose co-transporter-2 (SGLT-2) inhibitors in case of a high risk of cardiovascular disease (as judged by the investigator), or established cardiovascular disease, or chronic kidney disease (Glomerular Filtration Rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter [ml/min/1.73 m^2]).

•Glycated hemoglobin (HbA1c) at screening of 6.5-9.5 percent (48-80 millimoles per mole [mmol/mol]) (both inclusive) if on metformin only, or 6.0- 9.0 percent (42-75 mmol/mol) (both inclusive) if on metformin in combination with one other OAD. A minimum of 65% of randomised participants must have HbA1c >= 7.0 % at screening.

•Body Mass index (BMI) between 25.0 and 45.0 kilogram per square meter (kg/m^2) (both inclusive) at screening.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.

•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.

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 45 ml/min/1.73 m^2 at screening.

•Treatment with any medication for the indication of T2D or weight management 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.

Endpoints (26)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Safety / tolerability / PK

Other (unclassified)

Glycemic / diabetes

23 endpoints

Primary/protocol endpoint

To compare the effect of CagriSema versus placebo: Change in M-value in hyperinsulinaemic euglycaemic clamp (HEC)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

To compare the effect of CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

To compare the effect of CagriSema versus placebo, CagriSema versus semaglutide, Semaglutide versus placebo and Cagrilintide versus placebo: Change in M-value in HEC, normalised by lean body mass

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in first-phase incremental insulin secretion rate (ISR0-8min) in hyperglycaemic clamp (HGC)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in second-phase insulin secretion rate (ISR20-120min) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in total insulin secretion rate (ISR0-120min) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in insulin secretion rate at fixed glucose concentration (ISRg) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in total insulin response (total AUC0-120 min) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin response to arginine (incremental insulin AUCarginine,0-10min) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in C-peptide response to arginine (incremental insulin AUCarginine,0-10min) in HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in clamp disposition index (cDI) calculated from HEC and HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in cDI calculated from HEC and HGC,based on lean body mass

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in β-cell glucose sensitivity (insulin secretion) from HGC

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in glucose concentration during MMTT (total and incremental AUC0-300min)

Time frame:Baseline to week 28

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin concentration during MMTT (total and incremental AUC0-300min)

Time frame:Baseline to week 28

concentration, descriptive

Secondary/protocol endpoint

Change in C-peptide concentration during MMTT (total and incremental AUC0-300min)

Time frame:Baseline to week 28

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in glucagon concentration during MMTT (total and incremental AUC0-300min)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting glucose concentration (MMTT pre-meal concentrations)

Time frame:Baseline to week 28

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in fasting insulin concentration (MMTT pre-meal concentrations)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting C-peptide concentration (MMTT pre-meal concentrations)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting proinsulin concentration (MMTT pre-meal concentrations)

Time frame:Baseline to week 28

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c

Time frame:Baseline to week 28

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in systolic and diastolic blood pressure

Time frame:Baseline to week 28

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline to end of study (week 34)

Treatment-emergent AEs (any)

event count, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change in fasting glucagon concentration (MMTT pre-meal concentrations)

Time frame:Baseline to week 28

change from baseline, improvement

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.