A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
NCT ID: NCT06326047
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
299 participants
INTERVENTIONAL
2024-03-18
2025-10-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dosing scheme A (NNC0519-0130)
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme A (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme B (NNC0519-0130)
Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme B (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme C (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme C (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme D (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme D (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme E (NNC0519-0130)
Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme E (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme F (tirzepatide)
Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
Trizepatide
Trizepatide will be administered subcutaneously.
Interventions
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NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Trizepatide
Trizepatide will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Velocity Clin Res-Chula Vista
Chula Vista, California, United States
Valley Research
Fresno, California, United States
310 Clinical Research
Inglewood, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
First Valley Med Grp Lancaster
Lancaster, California, United States
Torrance Clin Res Inst, Inc.
Lomita, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
Med Partners, Inc.
Toluca Lake, California, United States
UCLA Health Southbay Endocrine
Torrance, California, United States
University Clin Investigators
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Innovative Research of W Florida Inc.
Clearwater, Florida, United States
Innovative Research of W FL
Clearwater, Florida, United States
International Research Associates, LLC_Miami
Miami, Florida, United States
Centricity Research
Columbus, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Centennial Medical Group
Columbia, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Endo And Metab Cons
Rockville, Maryland, United States
Clinvest Research
Springfield, Missouri, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Excel Clinical Network
Las Vegas, Nevada, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Velocity Clinical Research Binghamton
Binghamton, New York, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare Wilmington
Wilmington, North Carolina, United States
Diab & Endo Assoc of Stark Co
Canton, Ohio, United States
Velocity Clin Res_Cincinnati
Cincinnati, Ohio, United States
Velocity Clinical Research Springdale
Cincinnati, Ohio, United States
Providence Health Partners Ctr
Dayton, Ohio, United States
Advanced Med Res Maumee
Maumee, Ohio, United States
Tristar Clin Investigations, PC
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States
Velocity Clinical Research Abilene
Abilene, Texas, United States
Tekton Research
Austin, Texas, United States
Velocity Clin Res Austin
Austin, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Zenos Clinical research
Dallas, Texas, United States
Care United Research, LLC
Forney, Texas, United States
Endocrine Associates Houston
Houston, Texas, United States
Biopharma Informatic_Houston
Houston, Texas, United States
Epic Clinical Research
Lewisville, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Burke Internal Medicine & Research
Burke, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
Macquarie University
Macquarie Park, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Roger Chih Yu Chen
Sydney, New South Wales, Australia
Western Endocrine Blacktown
Sydney, New South Wales, Australia
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, Australia
University of Sunshine Coast
Birtinya, Queensland, Australia
Eastern Clinical Research Unit Box Hill
Box Hill, Victoria, Australia
Emeritus Research Melbourne
Camberwell, Victoria, Australia
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
OCT Research ULC (dba Okanagan Clinical Trials)
Richmond, British Columbia, Canada
Cook Street Medical Clinic
Victoria, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
Albion Finch Medical Centre
Toronto, Ontario, Canada
Centricity Research Quebec City
Lévis, Quebec, Canada
Recherche GCP Research
Montreal, Quebec, Canada
Centricity Research Ville St. Laurent VSL
Saint-Laurent, Quebec, Canada
Diex Recherche Quebec Inc.
Québec, , Canada
Life Care Hospital and Research Centre
Bangalore, Karnataka, India
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala, India
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
Chellaram Diabetes Institute
Pune, Maharashtra, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
Diabetes Research Center, Hyderabad
Hyderabad, Telangana, India
MS Ramaiah
Bengaluru, , India
Tokuyama clinic_Diabetic internal medicine
Chiba, , Japan
Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama, , Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, , Japan
Fukuwa Clinic_Internal Medicine
Tokyo, , Japan
Fukuwa Clinic
Tokyo, , Japan
Josha Research
Bloemfontein, Free State, South Africa
Wits Bara Clinical Trial Site
Johannesburg, Gauteng, South Africa
Shop#1 Health Emporium
Midrand, Gauteng, South Africa
Dr Pillay's Rooms
Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
eMkhomazi, KwaZulu-Natal, South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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U1111-1291-9196
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230704
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9541-4945
Identifier Type: -
Identifier Source: org_study_id