Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06326047




Registration number
NCT06326047
Ethics application status
Date submitted
16/03/2024
Date registered
22/03/2024
Date last updated
25/06/2024

Titles & IDs
Public title
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Scientific title
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Type 2 Diabetes - a Dose Finding Study
Secondary ID [1] 0 0
U1111-1291-9196
Secondary ID [2] 0 0
NN9541-4945
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNC0519-0130
Treatment: Drugs - Placebo
Treatment: Drugs - Trizepatide

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.


Treatment: Drugs: NNC0519-0130
NNC0519-0130 will be administered subcutaneously.

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.

Treatment: Drugs: Trizepatide
Trizepatide will be administered subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary outcome [1] 0 0
Change in Glycated haemoglobin (HbA1c)
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [2] 0 0
Relative change in body weight
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [3] 0 0
Change in body weight
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [4] 0 0
Change in fasting plasma glucose (FPG)
Timepoint [4] 0 0
From baseline (week 0) to 12 weeks on a given maintenance dose
Secondary outcome [5] 0 0
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))
Timepoint [5] 0 0
From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
Secondary outcome [6] 0 0
Change in waist circumference
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [7] 0 0
Change in systolic blood pressure (SBP)
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [8] 0 0
Change in high sensitivity C-Reactive Protein (hsCRP)
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [9] 0 0
Change in total cholesterol
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [10] 0 0
Change in high-density lipoprotein (HDL) cholesterol
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [11] 0 0
Change in low-density lipoprotein (LDL) cholesterol
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [12] 0 0
Change in triglycerides
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [13] 0 0
Number of adverse events
Timepoint [13] 0 0
From baseline (week 0) to end of study (week 40)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/08/2025
Actual
Sample size
Target
288
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Western Endocrine Blacktown - Sydney
Recruitment hospital [4] 0 0
Illawarra Diabetes Service Clinical Trials & Research Unit - Wollongong
Recruitment hospital [5] 0 0
University of Sunshine Coast - Birtinya
Recruitment hospital [6] 0 0
Eastern Clinical Research Unit Box Hill - Box Hill
Recruitment hospital [7] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
2148 - Sydney
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4575 - Birtinya
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Canada
State/province [17] 0 0
British Columbia
Country [18] 0 0
Canada
State/province [18] 0 0
New Brunswick
Country [19] 0 0
Canada
State/province [19] 0 0
Nova Scotia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
India
State/province [22] 0 0
Karnataka
Country [23] 0 0
India
State/province [23] 0 0
Kerala
Country [24] 0 0
India
State/province [24] 0 0
Maharashtra
Country [25] 0 0
India
State/province [25] 0 0
Tamil Nadu
Country [26] 0 0
India
State/province [26] 0 0
Telangana
Country [27] 0 0
India
State/province [27] 0 0
Bengaluru
Country [28] 0 0
Japan
State/province [28] 0 0
Chiba
Country [29] 0 0
Japan
State/province [29] 0 0
Soka-shi, Saitama
Country [30] 0 0
Japan
State/province [30] 0 0
Tokyo
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Gyeonggi-do
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
South Africa
State/province [33] 0 0
Free State
Country [34] 0 0
South Africa
State/province [34] 0 0
Gauteng
Country [35] 0 0
South Africa
State/province [35] 0 0
KwaZulu-Natal

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06326047
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Transparency (dept. 2834)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Novo Nordisk
Address 0 0
Country 0 0
Phone 0 0
(+1) 866-867-7178
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06326047