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Diabetes Mellitus, Type 2Phase 2NCT06326047

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

A Phase 2 study testing NNC0519-0130 and Trizepatide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 110 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
NNC0519-0130 and Trizepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
299 participants
Where
110 sitesin 7 countries
Study dates
18 Mar 2024to 13 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

110 sites in 7 countries.

110 sites in 7 countries

United States55 sites

  • Velocity Clinical Research Abilene

    Abilene, Texas, 79606

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Velocity Clin Res Austin

    Austin, Texas, 78759

  • Velocity Clinical Research Binghamton

    Binghamton, New York, 13905

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Mercury Str Med Grp, PLLC

    Butte, Montana, 59701

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio, 44718

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • Velocity Clin Res_Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research Springdale

    Cincinnati, Ohio, 45246

  • Innovative Research of W Florida Inc.

    Clearwater, Florida, 33756

  • Innovative Research of W FL

    Clearwater, Florida, 33756

  • Centennial Medical Group

    Columbia, Maryland, 21045

  • Centricity Research

    Columbus, Georgia, 31904

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • Zenos Clinical research

    Dallas, Texas, 75230

  • UT Southwestern Med Center

    Dallas, Texas, 75390

  • Providence Health Partners Ctr

    Dayton, Ohio, 45439

  • Care United Research, LLC

    Forney, Texas, 75126

  • Valley Research

    Fresno, California, 93720

  • Velocity Clin Res Grants Pass

    Grants Pass, Oregon, 97527

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Endocrine Associates Houston

    Houston, Texas, 77004

  • Biopharma Informatic_Houston

    Houston, Texas, 77043

  • 310 Clinical Research

    Inglewood, California, 90301

  • University of Iowa

    Iowa City, Iowa, 52242

  • Tekton Research

    Irving, Texas, 75039

  • Velocity Clin Res San Diego

    La Mesa, California, 91942

  • First Valley Med Grp Lancaster

    Lancaster, California, 93534

  • Excel Clinical Network

    Las Vegas, Nevada, 89109

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada, 89148

  • Epic Clinical Research

    Lewisville, Texas, 75057

  • Velocity Clinical Research Lincoln

    Lincoln, Nebraska, 68510

  • Torrance Clin Res Inst, Inc.

    Lomita, California, 90717

  • Pacific Clinical Studies

    Los Alamitos, California, 90720

  • Velocity Clinical Research Westlake

    Los Angeles, California, 90057

  • Advanced Med Res Maumee

    Maumee, Ohio, 43537

  • International Research Associates, LLC_Miami

    Miami, Florida, 33183

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania, 19114

  • Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania, 15243

  • Endo And Metab Cons

    Rockville, Maryland, 20852

  • Artemis Insitute for Clin Res

    San Diego, California, 92123

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Clinvest Research

    Springfield, Missouri, 65807

  • Med Partners, Inc.

    Toluca Lake, California, 91602

  • UCLA Health Southbay Endocrine

    Torrance, California, 90505

  • University Clin Investigators

    Tustin, California, 92780

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania, 15401

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Accellacare Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

Australia15 sites

  • University of Sunshine Coast - Vitality Village

    Birtinya, Queensland, 4575

  • Eastern Clinical Research Unit Box Hill

    Box Hill, Victoria, 3128

  • Emeritus Research Melbourne

    Camberwell, Victoria, 3124

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Fremantle Hospital

    Fremantle, Western Australia, 6160

  • Austin Health, Metabolic Disorders Centre

    Heidelberg Heights, Victoria, 3081

  • Macquarie University - Clinical Trials Unit

    Macquarie Park, New South Wales, 2109

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

  • The Royal Melbourne Hospital - Diabetes & Endocrinology Department

    Parkville, Victoria, 3050

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Roger Chih Yu Chen

    Sydney, New South Wales, 2148

  • Western Endocrine Blacktown

    Sydney, New South Wales, 2148

  • Illawarra Diabetes Service Clinical Trials & Research Unit

    Wollongong, New South Wales, 2500

Other trials in Australia

Canada15 sites

  • Centricity Research Barrie

    Barrie, Ontario, L4N 7L3

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H 1V7

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia, V1Y 1Z9

  • Centricity Research Quebec City

    Lévis, Quebec, G6W 0M5

  • Centricity Research Mirabel

    Mirabel, Quebec, J7J 2K8

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Recherche GCP Research

    Montreal, Quebec, H1Y 3H5

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Richmond, British Columbia, V6V 2L1

  • Centricity Research Ville St. Laurent VSL

    Saint-Laurent, Quebec, H4T 1Z9

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

  • Albion Finch Medical Centre

    Toronto, Ontario, M9V 4B4

  • Cook Street Medical Clinic

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

India10 sites

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • MS Ramaiah

    Bengaluru, 560054

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana, 500082

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh, 452010

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra, 400012

  • Lady Hardinge Medical College

    New Delhi, 110001

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Japan5 sites

  • Tokuyama clinic_Diabetic internal medicine

    Chiba, 261-0004

  • Soka Sugiura Internal Medicine Clinic

    Soka-shi, Saitama, 340-0015

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Fukuwa Clinic

    Tokyo, 104-0031

Other trials in Japan

South Africa5 sites

  • Josha Research

    Bloemfontein, Free State, 9301

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal, 4450

  • Dr T Padayachee

    eMkhomazi, KwaZulu-Natal, 4170

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng, 2013

  • Dr A Jacovides and Partners Inc

    Midrand, Gauteng, 1685

Other trials in South Africa

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • Korea University Anam Hospital

    Seoul, 02841

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

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

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

Being tested
NNC0519-0130, Placebo, Trizepatide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0519-0130Drug

    NNC0519-0130 will be administered subcutaneously.

  • PlaceboDrug

    Placebo will be administered subcutaneously.

  • TrizepatideDrug

    Trizepatide will be administered subcutaneously.

Study groups in NCT06326047
Study groupRoleWhat they receive
Dosing scheme A (NNC0519-0130)ExperimentalParticipants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.
Receives: Drug: NNC0519-0130
Dosing scheme A (Placebo)Placebo comparatorParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Receives: Drug: Placebo
Dosing scheme B (NNC0519-0130)ExperimentalParticipants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.
Receives: Drug: NNC0519-0130
Dosing scheme B (Placebo)Placebo comparatorParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Receives: Drug: Placebo
Dosing scheme C (NNC0519-0130)ExperimentalParticipants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Receives: Drug: NNC0519-0130
Dosing scheme C (Placebo)Placebo comparatorParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Receives: Drug: Placebo
Dosing scheme D (NNC0519-0130)ExperimentalParticipants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Receives: Drug: NNC0519-0130
Dosing scheme D (Placebo)Placebo comparatorParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Receives: Drug: Placebo
Dosing scheme E (NNC0519-0130)ExperimentalParticipants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
Receives: Drug: NNC0519-0130
Dosing scheme E (Placebo)Placebo comparatorParticipants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Receives: Drug: Placebo
Dosing scheme F (tirzepatide)Active comparatorParticipants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
Receives: Drug: Trizepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycated haemoglobin (HbA1c)

    Measured as percentage point (%-point)

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

Secondary outcomes (13)

  1. Change in Glycated haemoglobin (HbA1c)

    Measured as percentage point (%-point)

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

  2. Relative change in body weight

    Measured as percentage (%)

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

  3. Change in body weight

    Measured as kilograms (kg)

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

  4. Change in fasting plasma glucose (FPG)

    Measured as millimoles per liter (mmol/L)

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

  5. 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))

    Measured as percentage point (%-point)

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

  6. Change in waist circumference

    Measured as centimeter (cm)

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

  7. Change in systolic blood pressure (SBP)

    Measured as millimeters of mercury (mmHg)

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

  8. Change in high sensitivity C-Reactive Protein (hsCRP)

    Measured as ratio to baseline

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

  9. Change in total cholesterol

    Measured as ratio to baseline

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

  10. Change in high-density lipoprotein (HDL) cholesterol

    Measured as ratio to baseline

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

  11. Change in low-density lipoprotein (LDL) cholesterol

    Measured as ratio to baseline

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

  12. Change in triglycerides

    Measured as ratio to baseline

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

  13. Number of adverse events

    Measured as number of events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2024
  2. Study start18 Mar 2024
  3. Primary completion19 Sep 2025
  4. Study completion13 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06326047
Sponsor's protocol ID
NN9541-4945
Other IDs
U1111-1291-9196, jRCT2031230704
Status last verified
Sep 2026
First submitted
16 Mar 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NNC0519-0130 and Trizepatide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 110 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Australia, Canada, India, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to 12 weeks on a given maintenance dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06326047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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Clinical Trial NCT06326047 | AzTrials