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

Status: Recruiting
Location: See all (115) 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
COMPLETED
Chula Vista
Valley Research
NOT_YET_RECRUITING
Fresno
Valley Research
WITHDRAWN
Fresno
310 Clinical Research
ACTIVE_NOT_RECRUITING
Inglewood
Velocity Clin Res San Diego
COMPLETED
La Mesa
First Valley Med Grp Lancaster
ACTIVE_NOT_RECRUITING
Lancaster
Torrance Clin Res Inst, Inc.
RECRUITING
Lomita
Torrance Clin Res Inst, Inc.
COMPLETED
Lomita
Pacific Clinical Studies
RECRUITING
Los Alamitos
Pacific Clinical Studies
ACTIVE_NOT_RECRUITING
Los Alamitos
Catalina Research Institute, LLC
RECRUITING
Montclair
Catalina Research Institute, LLC
ACTIVE_NOT_RECRUITING
Montclair
Med Partners, Inc.
COMPLETED
Toluca Lake
UCLA Health Southbay Endocrine
WITHDRAWN
Torrance
University Clin Investigators
ACTIVE_NOT_RECRUITING
Tustin
Diablo Clinical Research, Inc.
ACTIVE_NOT_RECRUITING
Walnut Creek
Colorado
University of Colorado Hospital
ACTIVE_NOT_RECRUITING
Aurora
Florida
Innovative Research of W FL
COMPLETED
Clearwater
Innovative Research of W Florida Inc.
RECRUITING
Clearwater
International Research Associates, LLC_Miami
RECRUITING
Miami
International Research Associates, LLC_Miami
ACTIVE_NOT_RECRUITING
Miami
Georgia
Centricity Research
ACTIVE_NOT_RECRUITING
Columbus
Idaho
Elite Clinical Trials
ACTIVE_NOT_RECRUITING
Blackfoot
Illinois
Methodist Medical Center of Illinois
ACTIVE_NOT_RECRUITING
Peoria
Maryland
Centennial Medical Group
ACTIVE_NOT_RECRUITING
Columbia
MD Medical Research
RECRUITING
Oxon Hill
MD Medical Research
ACTIVE_NOT_RECRUITING
Oxon Hill
Endo And Metab Cons
WITHDRAWN
Rockville
Missouri
Clinvest Research
ACTIVE_NOT_RECRUITING
Springfield
Montana
Mercury Str Med Grp, PLLC
COMPLETED
Butte
North Carolina
PharmQuest Life Sciences LLC
COMPLETED
Greensboro
Accellacare Wilmington
COMPLETED
Wilmington
Accellacare Wilmington
NOT_YET_RECRUITING
Wilmington
Nevada
Excel Clinical Network
ACTIVE_NOT_RECRUITING
Las Vegas
Palm Research Center Inc-Vegas
ACTIVE_NOT_RECRUITING
Las Vegas
New York
Velocity Clinical Research Binghamton
COMPLETED
Binghamton
Ohio
Diab & Endo Assoc of Stark Co
COMPLETED
Canton
Velocity Clin Res_Cincinnati
RECRUITING
Cincinnati
Velocity Clin Res_Cincinnati
COMPLETED
Cincinnati
Velocity Clinical Research Springdale
COMPLETED
Cincinnati
Velocity Clinical Research Springdale
RECRUITING
Cincinnati
Providence Health Partners Ctr
COMPLETED
Dayton
Advanced Med Res Maumee
COMPLETED
Maumee
Pennsylvania
Tristar Clin Investigations, PC
WITHDRAWN
Philadelphia
Preferred Primary Care Physicians Inc.
ACTIVE_NOT_RECRUITING
Pittsburgh
Preferred Primary Care Physicians, Inc.
COMPLETED
Uniontown
Texas
Velocity Clinical Research Abilene
ACTIVE_NOT_RECRUITING
Abilene
Velocity Clin Res Austin
ACTIVE_NOT_RECRUITING
Austin
Velocity Clinical Res-Dallas
ACTIVE_NOT_RECRUITING
Dallas
Zenos Clinical research
COMPLETED
Dallas
Care United Research, LLC
ACTIVE_NOT_RECRUITING
Forney
Biopharma Informatic_Houston
NOT_YET_RECRUITING
Houston
Biopharma Informatic_Houston
ACTIVE_NOT_RECRUITING
Houston
Endocrine Associates Houston
WITHDRAWN
Houston
Tekton Research
ACTIVE_NOT_RECRUITING
Irving
Epic Clinical Research
ACTIVE_NOT_RECRUITING
Lewisville
Consano Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Shavano Park
Virginia
Burke Internal Medicine & Research
COMPLETED
Burke
TPMG Clinical Research
COMPLETED
Newport News
Other Locations
Australia
University of Sunshine Coast
COMPLETED
Birtinya
Eastern Clinical Research Unit Box Hill
ACTIVE_NOT_RECRUITING
Box Hill
Emeritus Research Melbourne
COMPLETED
Camberwell
Austin Health, Metabolic Disorders Centre
ACTIVE_NOT_RECRUITING
Heidelberg Heights
Austin Health, Metabolic Disorders Centre
RECRUITING
Heidelberg Heights
Macquarie University
ACTIVE_NOT_RECRUITING
Macquarie Park
The Royal Melbourne Hospital
RECRUITING
Parkville
The Royal Melbourne Hospital
ACTIVE_NOT_RECRUITING
Parkville
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
St Leonards
Roger Chih Yu Chen
WITHDRAWN
Sydney
Western Endocrine Blacktown
NOT_YET_RECRUITING
Sydney
Illawarra Diabetes Service Clinical Trials & Research Unit
ACTIVE_NOT_RECRUITING
Wollongong
Illawarra Diabetes Service Clinical Trials & Research Unit
RECRUITING
Wollongong
Canada
Nova Scotia Hlth Halifax
RECRUITING
Halifax
Nova Scotia Hlth Halifax
COMPLETED
Halifax
Wharton Med Clin Trials
ACTIVE_NOT_RECRUITING
Hamilton
OCT Research ULC (dba Okanagan Clinical Trials)
COMPLETED
Kelowna
OCT Research ULC (dba Okanagan Clinical Trials)
RECRUITING
Kelowna
Centricity Research Quebec City
COMPLETED
Lévis
G.A. Research Associates Ltd.
RECRUITING
Moncton
G.A. Research Associates Ltd.
ACTIVE_NOT_RECRUITING
Moncton
Recherche GCP Research
ACTIVE_NOT_RECRUITING
Montreal
Diex Recherche Quebec Inc.
ACTIVE_NOT_RECRUITING
Québec
OCT Research ULC (dba Okanagan Clinical Trials)
ACTIVE_NOT_RECRUITING
Richmond
OCT Research ULC (dba Okanagan Clinical Trials)
NOT_YET_RECRUITING
Richmond
Centricity Research Ville St. Laurent VSL
WITHDRAWN
Saint-laurent
Albion Finch Medical Centre
ACTIVE_NOT_RECRUITING
Toronto
Albion Finch Medical Centre
NOT_YET_RECRUITING
Toronto
Albion Finch Medical Centre
COMPLETED
Toronto
Cook Street Medical Clinic
RECRUITING
Victoria
Cook Street Medical Clinic
ACTIVE_NOT_RECRUITING
Victoria
India
Life Care Hospital and Research Centre
ACTIVE_NOT_RECRUITING
Bangalore
MS Ramaiah
ACTIVE_NOT_RECRUITING
Bengaluru
Diabetes Research Center, Hyderabad
ACTIVE_NOT_RECRUITING
Hyderabad
TOTALL Diabetes Hormone Institute
WITHDRAWN
Indore
Diabetes, Thyroid and Endocrine Centre
ACTIVE_NOT_RECRUITING
Jaipur
Amrita Institute Of Medical Sciences & Research Centre
ACTIVE_NOT_RECRUITING
Kochi
Seth GS Medical College & KEM Hospital
ACTIVE_NOT_RECRUITING
Mumbai
Chellaram Diabetes Institute
ACTIVE_NOT_RECRUITING
Pune
Christian Medical College Hospital, Vellore
ACTIVE_NOT_RECRUITING
Vellore
Japan
Tokuyama clinic_Diabetic internal medicine
ACTIVE_NOT_RECRUITING
Chiba
Soka Sugiura Internal Medicine Clinic
NOT_YET_RECRUITING
Soka-shi, Saitama
Soka Sugiura Internal Medicine Clinic
ACTIVE_NOT_RECRUITING
Soka-shi, Saitama
Fukuwa Clinic
NOT_YET_RECRUITING
Tokyo
Fukuwa Clinic_Internal Medicine
COMPLETED
Tokyo
Tokyo-Eki Center-building Clinic_Internal Medicine
COMPLETED
Tokyo
Republic of Korea
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING
Gyeonggi-do
Asan Medical Center
COMPLETED
Seoul
Kangbuk Samsung Hospital
ACTIVE_NOT_RECRUITING
Seoul
Korea University Anam Hospital
ACTIVE_NOT_RECRUITING
Seoul
Nowon Eulji Medical Center, Eulji University
ACTIVE_NOT_RECRUITING
Seoul
South Africa
Josha Research
WITHDRAWN
Bloemfontein
Dr Pillay's Rooms
WITHDRAWN
Durban
Dr T Padayachee
WITHDRAWN
Emkhomazi
Wits Bara Clinical Trial Site
WITHDRAWN
Johannesburg
Shop#1 Health Emporium
WITHDRAWN
Midrand
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2025-10-13
Participants
Target number of participants: 288
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