Clinical trial NCT06326047: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Official title: Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary outcomes:
measure: Change in Glycated haemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in fasting plasma glucose (FPG)
timeFrame: From baseline (week 0) to 12 weeks on a given maintenance dose
measure: 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))
timeFrame: From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in high sensitivity C-Reactive Protein (hsCRP)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in high-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Number of adverse events
timeFrame: From baseline (week 0) to end of study (week 40)
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Velocity Clin Res-Chula Vista
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: La Mesa
country: United States
facility: Velocity Clin Res San Diego
state: California
city: Lancaster
country: United States
facility: First Valley Med Grp Lancaster
state: California
city: Lomita
country: United States
facility: Torrance Clin Res Inst, Inc.
state: California
city: Lomita
country: United States
facility: Torrance Clin Res Inst, Inc.
state: California
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies
state: California
city: Los Alamitos
country: United States
facility: Pacific Clinical Studies
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc.
state: California
city: Torrance
country: United States
facility: UCLA Health Southbay Endocrine
state: California
city: Tustin
country: United States
facility: University Clin Investigators
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Clearwater
country: United States
facility: Innovative Research of W Florida Inc.
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of W FL
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC_Miami
state: Florida
city: Miami
country: United States
facility: International Research Associates, LLC_Miami
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Rockville
country: United States
facility: Endo And Metab Cons
state: Maryland
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Butte
country: United States
facility: Mercury Str Med Grp, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Excel Clinical Network
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Inc-Vegas
state: Nevada
city: Binghamton
country: United States
facility: Velocity Clinical Research Binghamton
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare Wilmington
state: North Carolina
city: Canton
country: United States
facility: Diab & Endo Assoc of Stark Co
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clin Res_Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clin Res_Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research Springdale
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research Springdale
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners Ctr
state: Ohio
city: Maumee
country: United States
facility: Advanced Med Res Maumee
state: Ohio
city: Philadelphia
country: United States
facility: Tristar Clin Investigations, PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians, Inc.
state: Pennsylvania
city: Abilene
country: United States
facility: Velocity Clinical Research Abilene
state: Texas
city: Austin
country: United States
facility: Velocity Clin Res Austin
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical research
state: Texas
city: Forney
country: United States
facility: Care United Research, LLC
state: Texas
city: Houston
country: United States
facility: Endocrine Associates Houston
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic_Houston
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic_Houston
state: Texas
city: Irving
country: United States
facility: Tekton Research
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine & Research
state: Virginia
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Roger Chih Yu Chen
state: New South Wales
city: Sydney
country: Australia
facility: Western Endocrine Blacktown
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Diabetes Service Clinical Trials & Research Unit
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Diabetes Service Clinical Trials & Research Unit
state: New South Wales
city: Birtinya
country: Australia
facility: University of Sunshine Coast
state: Queensland
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit Box Hill
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit Box Hill
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Austin Health, Metabolic Disorders Centre
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Austin Health, Metabolic Disorders Centre
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Kelowna
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Kelowna
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Richmond
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Richmond
country: Canada
facility: OCT Research ULC (dba Okanagan Clinical Trials)
state: British Columbia
city: Victoria
country: Canada
facility: Cook Street Medical Clinic
state: British Columbia
city: Victoria
country: Canada
facility: Cook Street Medical Clinic
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Moncton
country: Canada
facility: G.A. Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Hlth Halifax
state: Nova Scotia
city: Hamilton
country: Canada
facility: Wharton Med Clin Trials
state: Ontario
city: Toronto
country: Canada
facility: Albion Finch Medical Centre
state: Ontario
city: Toronto
country: Canada
facility: Albion Finch Medical Centre
state: Ontario
city: Levis
country: Canada
facility: Centricity Research Quebec City
state: Quebec
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Ville Saint-Laurent
country: Canada
facility: Centricity Research Ville St. Laurent VSL
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc.
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Kochi
country: India
facility: Amrita Institute Of Medical Sciences & Research Centre
state: Kerala
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Mumbai
country: India
facility: Seth GS Medical College & KEM Hospital
state: Maharashtra
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Jaipur
country: India
facility: Diabetes, Thyroid and Endocrine Centre
state: Rajasthan
city: Vellore
country: India
facility: Christian Medical College Hospital, Vellore
state: Tamil Nadu
city: Hyderabad
country: India
facility: Diabetes Research Center, Hyderabad
state: Telangana
city: Bengaluru
country: India
facility: MS Ramaiah
city: Chiba
country: Japan
facility: Tokuyama clinic
city: Soka-shi, Saitama
country: Japan
facility: Soka Sugiura Internal Medicine Clinic
city: Soka-shi, Saitama
country: Japan
facility: Soka Sugiura Internal Medicine Clinic
city: Tokyo
country: Japan
facility: Tokyo-Eki Center-building Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Tokyo
country: Japan
facility: Fukuwa Clinic
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Bloemfontein
country: South Africa
facility: Josha Research
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Bara Clinical Trial Site
state: Gauteng
city: Midrand
country: South Africa
facility: Shop#1 Health Emporium
state: Gauteng
city: Durban
country: South Africa
facility: Dr Pillay's Rooms
state: KwaZulu-Natal
city: Umkomaas
country: South Africa
facility: Dr T Padayachee
state: KwaZulu-Natal
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: