GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study

Lead sponsor

Novo Nordisk A/S

Assets

NNC0519-0130 / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

299

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7.5-10%

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 IDNCT06326047

Org study IDNN9541-4945

Secondary IDjRCT2031230704JRCT

Secondary IDU1111-1291-9196World Health Organization (WHO)

Timeline

Milestones

Study start2024-03-18actual

Study first posted2024-03-22actual

Primary completion2025-09-19actual

Study completion2025-10-13actual

Last update posted2025-12-31actual

Assets

Investigational agents

NNC0519-0130 Tirzepatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Female of non-childbearing potential, or male.

•For United States (US) only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency and willingness to continue using it through-out the study or male.

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

•Diagnosed with type 2 diabetes mellitus greater than or equal 180 days before screening.

•Stable daily dose(s) more than or equal 90 days before screening 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 sodium-glucose co-transporter 2 (SGLT2) inhibitor.

•Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.

•Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).

Exclusion criteria

•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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

•Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question.

Endpoints (14)

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

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to end of treatment (week 36)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to end of treatment (week 36)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to end of treatment (week 36)

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change in Glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to 12 weeks on a given maintenance dose

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 36)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (week 0) to 12 weeks on a given maintenance dose

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))

Time frame:From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively

CGM time-in-range

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

Time frame:From baseline (week 0) to end of treatment (week 36)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in high sensitivity C-Reactive Protein (hsCRP)

Time frame:From baseline (week 0) to end of treatment (week 36)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in total cholesterol

Time frame:From baseline (week 0) to end of treatment (week 36)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in high-density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 36)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in low-density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to end of treatment (week 36)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in triglycerides

Time frame:From baseline (week 0) to end of treatment (week 36)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of adverse events

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

Treatment-emergent AEs (any)

event count, event

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.