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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: NNC0519-0130; Drug: Trizepatide

• Study Type: Interventional
• Enrollment (Estimated): 288
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Not yet recruiting
      • Macquarie University
    • St Leonards, New South Wales, Australia, 2065
      • Not yet recruiting
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2148
      • Not yet recruiting
      • Western Endocrine Blacktown
    • Sydney, New South Wales, Australia, 2148
      • Withdrawn
      • Western Endocrine Blacktown
    • Wollongong, New South Wales, Australia, 2500
      • Not yet recruiting
      • Illawarra Diabetes Service Clinical Trials & Research Unit
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Not yet recruiting
      • University of Sunshine Coast
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Not yet recruiting
      • Eastern Clinical Research Unit Box Hill
    • Heidelberg Heights, Victoria, Australia, 3081
      • Not yet recruiting
      • Austin Health, Metabolic Disorders Centre
    • Parkville, Victoria, Australia, 3050
      • Not yet recruiting
      • The Royal Melbourne Hospital
• Canada
  • Quebec, Canada, G1V 4T3
    • Not yet recruiting
    • Diex Recherche Quebec Inc.
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Recruiting
      • OCT Research ULC (dba Okanagan Clinical Trials)
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Not yet recruiting
      • OCT Research ULC (dba Okanagan Clinical Trials)
    • Victoria, British Columbia, Canada, V8V 4A1
      • Recruiting
      • Cook Street Medical Clinic
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Recruiting
      • G.A. Research Associates Ltd.
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Not yet recruiting
      • Nova Scotia Hlth Halifax
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Recruiting
      • Wharton Med Clin Trials
    • Toronto, Ontario, Canada, M9V 4B4
      • Recruiting
      • Albion Finch Medical Centre
    • Toronto, Ontario, Canada, M9V 4B4
      • Not yet recruiting
      • Albion Finch Medical Centre
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • Recruiting
      • Centricity Research Quebec City
    • Montreal, Quebec, Canada, H1Y 3H5
      • Not yet recruiting
      • Recherche GCP Research
    • Ville Saint-Laurent, Quebec, Canada, H4T 1Z9
      • Withdrawn
      • Centricity Research Ville St. Laurent VSL
• India
  • Bengaluru, India, 560054
    • Not yet recruiting
    • MS Ramaiah
  • Karnataka
    • Bangalore, Karnataka, India, 560092
      • Not yet recruiting
      • Life Care Clinic & Research Centre
  • Kerala
    • Kochi, Kerala, India, 682041
      • Not yet recruiting
      • Amrita Institute Of Medical Sciences & Research Centre
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Not yet recruiting
      • Seth GS Medical College & KEM Hospital
    • Pune, Maharashtra, India, 411021
      • Not yet recruiting
      • Chellaram Diabetes Institute
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632004
      • Not yet recruiting
      • Christian Medical College Hospital, Vellore
  • Telangana
    • Hyderabad, Telangana, India, 500072
      • Not yet recruiting
      • Kumudini Devi Diabetes Research Center, Ramdevrao Hospital
• Japan
  • Chiba, Japan, 261-0004
    • Recruiting
    • Tokuyama clinic
  • Soka-shi, Saitama, Japan, 340-0015
    • Recruiting
    • Soka Sugiura Internal Medicine Clinic
  • Soka-shi, Saitama, Japan, 340-0015
    • Not yet recruiting
    • Soka Sugiura Internal Medicine Clinic
  • Tokyo, Japan, 103-0027
    • Recruiting
    • Tokyo-Eki Center-building Clinic
  • Tokyo, Japan, 104-0031
    • Recruiting
    • Fukuwa Clinic
  • Tokyo, Japan, 104-0031
    • Not yet recruiting
    • Fukuwa Clinic
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13620
    • Not yet recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Not yet recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of, 03181
    • Not yet recruiting
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 02841
    • Not yet recruiting
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 01830
    • Not yet recruiting
    • Nowon Eulji Medical Center, Eulji University
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Withdrawn
      • Josha Research
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Withdrawn
      • Wits Bara Clinical Trial Site
    • Midrand, Gauteng, South Africa, 1685
      • Withdrawn
      • Shop#1 Health Emporium
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 4450
      • Withdrawn
      • Dr Pillay's Rooms
    • Umkomaas, KwaZulu-Natal, South Africa, 4170
      • Withdrawn
      • Dr T Padayachee
• United States
  • California
    • Chula Vista, California, United States, 91911
      • Recruiting
      • Velocity Clin Res-Chula Vista
    • Fresno, California, United States, 93720
      • Not yet recruiting
      • Valley Research
    • Fresno, California, United States, 93720
      • Withdrawn
      • Valley Research
    • La Mesa, California, United States, 91942
      • Recruiting
      • Velocity Clin Res San Diego
    • Lancaster, California, United States, 93534
      • Recruiting
      • First Valley Med Grp Lancaster
    • Lomita, California, United States, 90717
      • Recruiting
      • Torrance Clin Res Inst, Inc.
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Pacific Clinical Studies
    • Montclair, California, United States, 91763
      • Recruiting
      • Catalina Research Institute, LLC
    • Toluca Lake, California, United States, 91602
      • Recruiting
      • Med Partners, Inc.
    • Torrance, California, United States, 90505
      • Not yet recruiting
      • UCLA Health Southbay Endocrine
    • Tustin, California, United States, 92780
      • Recruiting
      • University Clin Investigators
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Innovative Research of W Florida Inc.
    • Miami, Florida, United States, 33183
      • Recruiting
      • International Research Associates, LLC_Miami
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Recruiting
      • Centricity Research
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Recruiting
      • Elite Clinical Trials
  • Illinois
    • Peoria, Illinois, United States, 61636
      • Recruiting
      • Methodist Medical_Center of Illinois
  • Maryland
    • Oxon Hill, Maryland, United States, 20745
      • Recruiting
      • MD Medical Research
    • Rockville, Maryland, United States, 20852
      • Withdrawn
      • Endo And Metab Cons
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Recruiting
      • Clinvest Research
  • Montana
    • Butte, Montana, United States, 59701
      • Recruiting
      • Mercury Str Med Grp, PLLC
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Recruiting
      • Palm Research Center Inc-Vegas
  • New York
    • Binghamton, New York, United States, 13905
      • Recruiting
      • Velocity Clinical Research Binghamton
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Recruiting
      • PharmQuest Life Sciences LLC
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Accellacare Wilmington
    • Wilmington, North Carolina, United States, 28401
      • Not yet recruiting
      • Accellacare Wilmington
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Diab & Endo Assoc of Stark Co
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Velocity Clin Res_Cincinnati
    • Cincinnati, Ohio, United States, 45246
      • Recruiting
      • Velocity Clinical Research Springdale
    • Dayton, Ohio, United States, 45439
      • Recruiting
      • Providence Health Partners Ctr
    • Maumee, Ohio, United States, 43537
      • Recruiting
      • Advanced Med Res Maumee
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Recruiting
      • Tristar Clin Investigations, PC
    • Pittsburgh, Pennsylvania, United States, 15243
      • Recruiting
      • Preferred Primary Care Physicians Inc.
    • Uniontown, Pennsylvania, United States, 15401
      • Recruiting
      • Preferred Primary Care Physicians, Inc.
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • Velocity Clinical Research Abilene
    • Austin, Texas, United States, 78759
      • Recruiting
      • Velocity Clin Res Austin
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Velocity Clinical Res-Dallas
    • Houston, Texas, United States, 77043
      • Recruiting
      • Biopharma Informatic_Houston
    • Houston, Texas, United States, 77004
      • Recruiting
      • Endocrine Associates Houston
    • Houston, Texas, United States, 77043
      • Not yet recruiting
      • Biopharma Informatic_Houston
    • Shavano Park, Texas, United States, 78231
      • Recruiting
      • Consano Clinical Research, LLC
  • Virginia
    • Burke, Virginia, United States, 22015
      • Recruiting
      • Burke Internal Medicine & Research
    • Newport News, Virginia, United States, 23606
      • Recruiting
      • TPMG Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme A (Placebo); Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo; Placebo will be administered subcutaneously.
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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme B (Placebo); Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo; Placebo will be administered subcutaneously.
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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme C (Placebo); Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo; Placebo will be administered subcutaneously.
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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme D (Placebo); Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo; Placebo will be administered subcutaneously.
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.	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Dosing scheme E (Placebo); Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods.	Drug: Placebo; Placebo will be administered subcutaneously.
Active Comparator: Dosing scheme F (tirzepatide); Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner.	Drug: Trizepatide; Trizepatide will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated haemoglobin (HbA1c)	Measured as percentage point (%-point)	From baseline (week 0) to 12 weeks on a given maintenance dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycated haemoglobin (HbA1c)	Measured as percentage point (%-point)	From baseline (week 0) to end of treatment (week 36)
Relative change in body weight	Measured as percentage (%)	From baseline (week 0) to end of treatment (week 36)
Change in body weight	Measured as kilograms (kg)	From baseline (week 0) to end of treatment (week 36)
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
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
Change in waist circumference	Measured as centimeter (cm)	From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)	Measured as millimeters of mercury (mmHg)	From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Change in triglycerides	Measured as ratio to baseline	From baseline (week 0) to end of treatment (week 36)
Number of adverse events	Measured as number of events	From baseline (week 0) to end of study (week 40)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): August 26, 2025

Study Registration Dates

• First Submitted: March 16, 2024
• First Submitted That Met QC Criteria: March 16, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9541-4945; U1111-1291-9196 (Other Identifier: World Health Organization (WHO)); jRCT2031230704 (Registry Identifier: JRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No