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

NCT06326047 | Completed Phase 2 FDA Drug

• 3 other identifiers: NN9541-4945U1111-1291-9196jRCT2031230704
• Study Type: interventional
• Target: 299
• Locations: 7 countries
• Sites: 94

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glycated haemoglobin (HbA1c)

  Measured as percentage point (%-point)

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

Secondary Outcomes (13)

• Change in Glycated haemoglobin (HbA1c)

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

• Relative change in body weight

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

• Change in body weight

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

• Change in fasting plasma glucose (FPG)

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

• 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))

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

Study Arms (11)

Dosing scheme A (NNC0519-0130)

EXPERIMENTAL

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner.

Drug: NNC0519-0130

Dosing scheme A (Placebo)

PLACEBO COMPARATOR

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Drug: Placebo

Dosing scheme B (NNC0519-0130)

EXPERIMENTAL

Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner.

Drug: NNC0519-0130

Dosing scheme B (Placebo)

PLACEBO COMPARATOR

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Drug: Placebo

Dosing scheme C (NNC0519-0130)

EXPERIMENTAL

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Drug: NNC0519-0130

Dosing scheme C (Placebo)

PLACEBO COMPARATOR

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Drug: Placebo

Dosing scheme D (NNC0519-0130)

EXPERIMENTAL

Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.

Drug: NNC0519-0130

Dosing scheme D (Placebo)

PLACEBO COMPARATOR

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Drug: Placebo

Dosing scheme E (NNC0519-0130)

EXPERIMENTAL

Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.

Drug: NNC0519-0130

Dosing scheme E (Placebo)

PLACEBO COMPARATOR

Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.

Drug: Placebo

Dosing scheme F (tirzepatide)

ACTIVE COMPARATOR

Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.

Drug: Trizepatide

Interventions

NNC0519-0130 DRUG

NNC0519-0130 will be administered subcutaneously.

Dosing scheme A (NNC0519-0130); Dosing scheme B (NNC0519-0130); Dosing scheme C (NNC0519-0130); Dosing scheme D (NNC0519-0130); Dosing scheme E (NNC0519-0130)

Placebo DRUG

Placebo will be administered subcutaneously.

Dosing scheme A (Placebo); Dosing scheme B (Placebo); Dosing scheme C (Placebo); Dosing scheme D (Placebo); Dosing scheme E (Placebo)

Trizepatide DRUG

Trizepatide will be administered subcutaneously.

Dosing scheme F (tirzepatide)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (94)

Velocity Clin Res-Chula Vista

Chula Vista, California, 91911, United States

Location

Valley Research

Fresno, California, 93720, United States

Location

310 Clinical Research

Inglewood, California, 90301, United States

Location

Velocity Clin Res San Diego

La Mesa, California, 91942, United States

Location

First Valley Med Grp Lancaster

Lancaster, California, 93534, United States

Location

Torrance Clin Res Inst, Inc.

Lomita, California, 90717, United States

Location

Pacific Clinical Studies

Los Alamitos, California, 90720, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Med Partners, Inc.

Toluca Lake, California, 91602, United States

Location

UCLA Health Southbay Endocrine

Torrance, California, 90505, United States

Location

University Clin Investigators

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Innovative Research of W Florida Inc.

Clearwater, Florida, 33756, United States

Location

Innovative Research of W FL

Clearwater, Florida, 33756, United States

Location

International Research Associates, LLC_Miami

Miami, Florida, 33183, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Elite Clinical Trials

Blackfoot, Idaho, 83221, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61603, United States

Location

Centennial Medical Group

Columbia, Maryland, 21045, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Endo And Metab Cons

Rockville, Maryland, 20852, United States

Location

Clinvest Research

Springfield, Missouri, 65807, United States

Location

Mercury Str Med Grp, PLLC

Butte, Montana, 59701, United States

Location

Excel Clinical Network

Las Vegas, Nevada, 89109, United States

Location

Palm Research Center Inc-Vegas

Las Vegas, Nevada, 89148, United States

Location

Velocity Clinical Research Binghamton

Binghamton, New York, 13905, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare Wilmington

Wilmington, North Carolina, 28401, United States

Location

Diab & Endo Assoc of Stark Co

Canton, Ohio, 44718, United States

Location

Velocity Clin Res_Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research Springdale

Cincinnati, Ohio, 45246, United States

Location

Providence Health Partners Ctr

Dayton, Ohio, 45439, United States

Location

Advanced Med Res Maumee

Maumee, Ohio, 43537, United States

Location

Tristar Clin Investigations, PC

Philadelphia, Pennsylvania, 19114, United States

Location

Preferred Primary Care Physicians Inc.

Pittsburgh, Pennsylvania, 15243, United States

Location

Preferred Primary Care Physicians, Inc.

Uniontown, Pennsylvania, 15401, United States

Location

Velocity Clinical Research Abilene

Abilene, Texas, 79606, United States

Location

Tekton Research

Austin, Texas, 75039, United States

Location

Velocity Clin Res Austin

Austin, Texas, 78759, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Zenos Clinical research

Dallas, Texas, 75230, United States

Location

Care United Research, LLC

Forney, Texas, 75126, United States

Location

Endocrine Associates Houston

Houston, Texas, 77004, United States

Location

Biopharma Informatic_Houston

Houston, Texas, 77043, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Burke Internal Medicine & Research

Burke, Virginia, 22015, United States

Location

TPMG Clinical Research

Newport News, Virginia, 23606, United States

Location

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Roger Chih Yu Chen

Sydney, New South Wales, 2148, Australia

Location

Western Endocrine Blacktown

Sydney, New South Wales, 2148, Australia

Location

Illawarra Diabetes Service Clinical Trials & Research Unit

Wollongong, New South Wales, 2500, Australia

Location

University of Sunshine Coast

Birtinya, Queensland, 4575, Australia

Location

Eastern Clinical Research Unit Box Hill

Box Hill, Victoria, 3128, Australia

Location

Emeritus Research Melbourne

Camberwell, Victoria, 3124, Australia

Location

Austin Health, Metabolic Disorders Centre

Heidelberg Heights, Victoria, 3081, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

OCT Research ULC (dba Okanagan Clinical Trials)

Richmond, British Columbia, V6V 2L1, Canada

Location

Cook Street Medical Clinic

Victoria, British Columbia, V8V 4A1, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Albion Finch Medical Centre

Toronto, Ontario, M9V 4B4, Canada

Location

Centricity Research Quebec City

Lévis, Quebec, G6W 0M5, Canada

Location

Recherche GCP Research

Montreal, Quebec, H1Y 3H5, Canada

Location

Centricity Research Ville St. Laurent VSL

Saint-Laurent, Quebec, H4T 1Z9, Canada

Location

Diex Recherche Quebec Inc.

Québec, G1V 4T3, Canada

Location

Life Care Hospital and Research Centre

Bangalore, Karnataka, 560092, India

Location

Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, 682041, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

Seth GS Medical College & KEM Hospital

Mumbai, Maharashtra, 400012, India

Location

Chellaram Diabetes Institute

Pune, Maharashtra, 411021, India

Location

Diabetes, Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India

Location

Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, 632004, India

Location

Diabetes Research Center, Hyderabad

Hyderabad, Telangana, 500082, India

Location

MS Ramaiah

Bengaluru, 560054, India

Location

Tokuyama clinic_Diabetic internal medicine

Chiba, 261-0004, Japan

Location

Soka Sugiura Internal Medicine Clinic

Soka-shi, Saitama, 340-0015, Japan

Location

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

Location

Fukuwa Clinic_Internal Medicine

Tokyo, 104-0031, Japan

Location

Fukuwa Clinic

Tokyo, 104-0031, Japan

Location

Josha Research

Bloemfontein, Free State, 9301, South Africa

Location

Wits Bara Clinical Trial Site

Johannesburg, Gauteng, 2013, South Africa

Location

Shop#1 Health Emporium

Midrand, Gauteng, 1685, South Africa

Location

Dr Pillay's Rooms

Durban, KwaZulu-Natal, 4450, South Africa

Location

Dr T Padayachee

eMkhomazi, KwaZulu-Natal, 4170, South Africa

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: March 18, 2024
• Primary Completion: September 19, 2025
• Study Completion: October 13, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AU (10); KR (5); JP (5); ZA (5); IN (9); US (49); CA (11)