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

Status: Completed
Location: See all (94) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
Velocity Clin Res-Chula Vista
Chula Vista
Valley Research
Fresno
310 Clinical Research
Inglewood
Velocity Clin Res San Diego
La Mesa
First Valley Med Grp Lancaster
Lancaster
Torrance Clin Res Inst, Inc.
Lomita
Pacific Clinical Studies
Los Alamitos
Catalina Research Institute, LLC
Montclair
Med Partners, Inc.
Toluca Lake
UCLA Health Southbay Endocrine
Torrance
University Clin Investigators
Tustin
Diablo Clinical Research, Inc.
Walnut Creek
Colorado
University of Colorado Hospital
Aurora
Florida
Innovative Research of W FL
Clearwater
Innovative Research of W Florida Inc.
Clearwater
International Research Associates, LLC_Miami
Miami
Georgia
Centricity Research
Columbus
Idaho
Elite Clinical Trials
Blackfoot
Illinois
Methodist Medical Center of Illinois
Peoria
Maryland
Centennial Medical Group
Columbia
MD Medical Research
Oxon Hill
Endo And Metab Cons
Rockville
Missouri
Clinvest Research
Springfield
Montana
Mercury Str Med Grp, PLLC
Butte
North Carolina
PharmQuest Life Sciences LLC
Greensboro
Accellacare Wilmington
Wilmington
Nevada
Excel Clinical Network
Las Vegas
Palm Research Center Inc-Vegas
Las Vegas
New York
Velocity Clinical Research Binghamton
Binghamton
Ohio
Diab & Endo Assoc of Stark Co
Canton
Velocity Clin Res_Cincinnati
Cincinnati
Velocity Clinical Research Springdale
Cincinnati
Providence Health Partners Ctr
Dayton
Advanced Med Res Maumee
Maumee
Pennsylvania
Tristar Clin Investigations, PC
Philadelphia
Preferred Primary Care Physicians Inc.
Pittsburgh
Preferred Primary Care Physicians, Inc.
Uniontown
Texas
Velocity Clinical Research Abilene
Abilene
Velocity Clin Res Austin
Austin
Velocity Clinical Res-Dallas
Dallas
Zenos Clinical research
Dallas
Care United Research, LLC
Forney
Biopharma Informatic_Houston
Houston
Endocrine Associates Houston
Houston
Tekton Research
Irving
Epic Clinical Research
Lewisville
Consano Clinical Research, LLC
Shavano Park
Virginia
Burke Internal Medicine & Research
Burke
TPMG Clinical Research
Newport News
Other Locations
Australia
University of Sunshine Coast
Birtinya
Eastern Clinical Research Unit Box Hill
Box Hill
Emeritus Research Melbourne
Camberwell
Austin Health, Metabolic Disorders Centre
Heidelberg Heights
Macquarie University
Macquarie Park
The Royal Melbourne Hospital
Parkville
Royal North Shore Hospital
St Leonards
Roger Chih Yu Chen
Sydney
Western Endocrine Blacktown
Sydney
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong
Canada
Nova Scotia Hlth Halifax
Halifax
Wharton Med Clin Trials
Hamilton
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna
Centricity Research Quebec City
Lévis
G.A. Research Associates Ltd.
Moncton
Recherche GCP Research
Montreal
Diex Recherche Quebec Inc.
Québec
OCT Research ULC (dba Okanagan Clinical Trials)
Richmond
Centricity Research Ville St. Laurent VSL
Saint-laurent
Albion Finch Medical Centre
Toronto
Cook Street Medical Clinic
Victoria
India
Life Care Hospital and Research Centre
Bangalore
MS Ramaiah
Bengaluru
Diabetes Research Center, Hyderabad
Hyderabad
TOTALL Diabetes Hormone Institute
Indore
Diabetes, Thyroid and Endocrine Centre
Jaipur
Amrita Institute Of Medical Sciences & Research Centre
Kochi
Seth GS Medical College & KEM Hospital
Mumbai
Chellaram Diabetes Institute
Pune
Christian Medical College Hospital, Vellore
Vellore
Japan
Tokuyama clinic_Diabetic internal medicine
Chiba
Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama
Fukuwa Clinic
Tokyo
Fukuwa Clinic_Internal Medicine
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo
Republic of Korea
Seoul National University Bundang Hospital
Gyeonggi-do
Asan Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
South Africa
Josha Research
Bloemfontein
Dr Pillay's Rooms
Durban
Dr T Padayachee
Emkhomazi
Wits Bara Clinical Trial Site
Johannesburg
Shop#1 Health Emporium
Midrand
Time Frame
Start Date: 2024-03-18
Completion Date: 2025-10-13
Participants
Target number of participants: 299
Treatments
Experimental: 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.
Placebo_comparator: Dosing scheme A (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Experimental: 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.
Placebo_comparator: Dosing scheme B (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Experimental: Dosing scheme C (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Placebo_comparator: Dosing scheme C (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Experimental: Dosing scheme D (NNC0519-0130)
Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner.
Placebo_comparator: Dosing scheme D (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Experimental: Dosing scheme E (NNC0519-0130)
Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner.
Placebo_comparator: Dosing scheme E (Placebo)
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.
Active_comparator: Dosing scheme F (tirzepatide)
Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov