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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326047
• Other study ID #: NN9541-4945
• Secondary ID: U1111-1291-9196j
• Status: Recruiting
• Phase: Phase 2
• Start date: March 18, 2024
• Est. completion date: August 26, 2025

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: August 26, 2025
• Est. primary completion date: November 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
• Placebo
Placebo will be administered subcutaneously.
• Trizepatide
Trizepatide will be administered subcutaneously.

Locations

Country	Name	City	State
Australia	University of Sunshine Coast	Birtinya	Queensland
Australia	Eastern Clinical Research Unit Box Hill	Box Hill	Victoria
Australia	Austin Health, Metabolic Disorders Centre	Heidelberg Heights	Victoria
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Royal North Shore Hospital	St Leonards	New South Wales
Australia	Western Endocrine Blacktown	Sydney	New South Wales
Australia	Western Endocrine Blacktown	Sydney	New South Wales
Australia	Illawarra Diabetes Service Clinical Trials & Research Unit	Wollongong	New South Wales
Canada	Nova Scotia Hlth Halifax	Halifax	Nova Scotia
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	OCT Research ULC (dba Okanagan Clinical Trials)	Kelowna	British Columbia
Canada	OCT Research ULC (dba Okanagan Clinical Trials)	Kelowna	British Columbia
Canada	Centricity Research Quebec City	Levis	Quebec
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Recherche GCP Research	Montreal	Quebec
Canada	Diex Recherche Quebec Inc.	Quebec
Canada	Albion Finch Medical Centre	Toronto	Ontario
Canada	Albion Finch Medical Centre	Toronto	Ontario
Canada	Cook Street Medical Clinic	Victoria	British Columbia
Canada	Centricity Research Ville St. Laurent VSL	Ville Saint-Laurent	Quebec
India	Life Care Clinic & Research Centre	Bangalore	Karnataka
India	MS Ramaiah	Bengaluru
India	Kumudini Devi Diabetes Research Center, Ramdevrao Hospital	Hyderabad	Telangana
India	Amrita Institute Of Medical Sciences & Research Centre	Kochi	Kerala
India	Seth GS Medical College & KEM Hospital	Mumbai	Maharashtra
India	Chellaram Diabetes Institute	Pune	Maharashtra
India	Christian Medical College Hospital, Vellore	Vellore	Tamil Nadu
Japan	Tokuyama clinic	Chiba
Japan	Soka Sugiura Internal Medicine Clinic	Soka-shi, Saitama
Japan	Soka Sugiura Internal Medicine Clinic	Soka-shi, Saitama
Japan	Fukuwa Clinic	Tokyo
Japan	Fukuwa Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
South Africa	Josha Research	Bloemfontein	Free State
South Africa	Dr Pillay's Rooms	Durban	KwaZulu-Natal
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
South Africa	Shop#1 Health Emporium	Midrand	Gauteng
South Africa	Dr T Padayachee	Umkomaas	KwaZulu-Natal
United States	Velocity Clinical Research Abilene	Abilene	Texas
United States	University of Colorado Hospital	Aurora	Colorado
United States	Velocity Clin Res Austin	Austin	Texas
United States	Velocity Clinical Research Binghamton	Binghamton	New York
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Burke Internal Medicine & Research	Burke	Virginia
United States	Mercury Str Med Grp, PLLC	Butte	Montana
United States	Diab & Endo Assoc of Stark Co	Canton	Ohio
United States	Velocity Clin Res-Chula Vista	Chula Vista	California
United States	Velocity Clin Res_Cincinnati	Cincinnati	Ohio
United States	Velocity Clinical Research Springdale	Cincinnati	Ohio
United States	Innovative Research of W Florida Inc.	Clearwater	Florida
United States	Centricity Research	Columbus	Georgia
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Providence Health Partners Ctr	Dayton	Ohio
United States	Valley Research	Fresno	California
United States	Valley Research	Fresno	California
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Biopharma Informatic_Houston	Houston	Texas
United States	Biopharma Informatic_Houston	Houston	Texas
United States	Endocrine Associates Houston	Houston	Texas
United States	Velocity Clin Res San Diego	La Mesa	California
United States	First Valley Med Grp Lancaster	Lancaster	California
United States	Palm Research Center Inc-Vegas	Las Vegas	Nevada
United States	Torrance Clin Res Inst, Inc.	Lomita	California
United States	Pacific Clinical Studies	Los Alamitos	California
United States	Advanced Med Res Maumee	Maumee	Ohio
United States	International Research Associates, LLC_Miami	Miami	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	TPMG Clinical Research	Newport News	Virginia
United States	MD Medical Research	Oxon Hill	Maryland
United States	Methodist Medical_Center of Illinois	Peoria	Illinois
United States	Tristar Clin Investigations, PC	Philadelphia	Pennsylvania
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Endo And Metab Cons	Rockville	Maryland
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Clinvest Research	Springfield	Missouri
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	Preferred Primary Care Physicians, Inc.	Uniontown	Pennsylvania
United States	Accellacare Wilmington	Wilmington	North Carolina
United States	Accellacare Wilmington	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Canada,  India,  Japan,  Korea, Republic of,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated haemoglobin (HbA1c)	Measured as percentage point (%-point)	From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary	Change in Glycated haemoglobin (HbA1c)	Measured as percentage point (%-point)	From baseline (week 0) to end of treatment (week 36)
Secondary	Relative change in body weight	Measured as percentage (%)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in body weight	Measured as kilograms (kg)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in fasting plasma glucose (FPG)	Measured as millimoles per liter (mmol/L)	From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary	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)	From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
Secondary	Change in waist circumference	Measured as centimeter (cm)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in systolic blood pressure (SBP)	Measured as millimeters of mercury (mmHg)	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in high sensitivity C-Reactive Protein (hsCRP)	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in total cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in high-density lipoprotein (HDL) cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in low-density lipoprotein (LDL) cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Change in triglycerides	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Secondary	Number of adverse events	Measured as number of events	From baseline (week 0) to end of study (week 40)