GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study

Lead sponsor

Novo Nordisk A/S

Assets

NNC0519-0130 / Tirzepatide

Listed sites

Recruiting sites

—

Enrollment

354

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Body weight, % 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 IDNCT06326060

Org study IDNN9541-5015

Secondary IDjRCT2051230198JRCT

Secondary IDU1111-1291-9210World Health Organization (WHO)

Timeline

Milestones

Study start2024-03-18actual

Study first posted2024-03-22actual

Primary completion2025-04-10actual

Study completion2025-05-01actual

Last update posted2026-04-15actual

Assets

Investigational agents

NNC0519-0130 Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Female of non-childbearing potential, or male.

a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening 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.

•History of at least one self-reported unsuccessful dietary effort to lose body weight.

•a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

•b) BMI ≥ 30.0 kg/m2.

Exclusion criteria

•HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.

•History of type 1 or type 2 diabetes mellitus.

•Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

Endpoints (21)

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

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

8 endpoints

Primary/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

Achievement of greater than equal to (≥) 5% weight reduction

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 10% weight reduction

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

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 15% weight reduction

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

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of ≥ 20% weight reduction

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

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

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

BMI, change

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

2 endpoints

Secondary/protocol endpoint

Change in glycated hemoglobin (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 end of treatment (week 36)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

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

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT Psychosocial composite score

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT Physical Function score

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite-CT Total score

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

IWQOL-Lite total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of adverse events

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