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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06326060




Registration number
NCT06326060
Ethics application status
Date submitted
16/03/2024
Date registered
22/03/2024
Date last updated
19/09/2024

Titles & IDs
Public title
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Scientific title
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
Secondary ID [1] 0 0
U1111-1291-9210
Secondary ID [2] 0 0
NN9541-5015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

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

Experimental: Dosing scheme a: NNC0519-0130 - Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme a: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Experimental: Dosing scheme b: NNC0519-0130 - Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme b: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Experimental: Dosing scheme c: NNC0519-0130 - Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme c: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Experimental: Dosing scheme d: NNC0519-0130 - Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme d: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Experimental: Dosing scheme e: NNC0519-0130 - Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme e: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Experimental: Dosing scheme f: NNC0519-0130 - Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.

Placebo comparator: Dosing scheme f: Placebo - Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.

Active comparator: Dosing scheme g: Tirzepatide - Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.


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

Treatment: Drugs: Placebo
Placebo will be administered subcutaneously.

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

Outcomes
Primary outcome [1] 0 0
Relative change in body weight
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [1] 0 0
Change in body weight
Timepoint [1] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [2] 0 0
Achievement of greater than equal to (=) 5% weight reduction
Timepoint [2] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [3] 0 0
Achievement of = 10% weight reduction
Timepoint [3] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [4] 0 0
Achievement of = 15% weight reduction
Timepoint [4] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [5] 0 0
Achievement of = 20% weight reduction
Timepoint [5] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [6] 0 0
Change in body mass index (BMI)
Timepoint [6] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [7] 0 0
Change in waist circumference
Timepoint [7] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [8] 0 0
Change in glycated hemoglobin (HbA1c)
Timepoint [8] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [9] 0 0
Change in fasting plasma glucose (FPG)
Timepoint [9] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [10] 0 0
Change in systolic blood pressure (SBP)
Timepoint [10] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [11] 0 0
Change in high sensitivity C-Reactive protein (hsCRP)
Timepoint [11] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [12] 0 0
Change in total cholesterol
Timepoint [12] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [13] 0 0
Change in high-density lipoprotein (HDL) cholesterol
Timepoint [13] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [14] 0 0
Change in low-density lipoprotein (LDL) cholesterol
Timepoint [14] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [15] 0 0
Change in triglycerides
Timepoint [15] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [16] 0 0
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
Timepoint [16] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [17] 0 0
Change in IWQOL-Lite-CT Psychosocial composite score
Timepoint [17] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [18] 0 0
Change in IWQOL-Lite-CT Physical Function score
Timepoint [18] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [19] 0 0
Change in IWQOL-Lite-CT Total score
Timepoint [19] 0 0
From baseline (week 0) to end of treatment (week 36)
Secondary outcome [20] 0 0
Number of adverse events
Timepoint [20] 0 0
From baseline (week 0) to end of treatment (week 40)

Eligibility
Key inclusion criteria
* Female of non-childbearing potential, or male.

a. For US only: Female of childbearing potential using highly effective non-systemic methods of contraception with low user-dependency at least 2 months prior to screening 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.
* History of at least one self-reported unsuccessful dietary effort to lose body weight.
* a) BMI = 27.0 kg/m2 with the presence of at least one weight-related co-morbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
* b) BMI = 30.0 kg/m2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes mellitus.
* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening.

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
Active, not 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
5/05/2025
Actual
Sample size
Target
Accrual to date
Final
355
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical - Blacktown
Recruitment hospital [2] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [3] 0 0
Holdsworth House Clinical Research - Darlinghurst
Recruitment hospital [4] 0 0
Novatrials - Kotara
Recruitment hospital [5] 0 0
Paratus Clinical - Herston
Recruitment hospital [6] 0 0
University of Sunshine Coast - Sippy Downs
Recruitment hospital [7] 0 0
CMAX Clinical Research - Norwood
Recruitment hospital [8] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment hospital [9] 0 0
Austin Health, Metabolic Disorders Centre - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2289 - Kotara
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [7] 0 0
5067 - Norwood
Recruitment postcode(s) [8] 0 0
3124 - Camberwell
Recruitment postcode(s) [9] 0 0
3081 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
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
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Rhode Island
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Japan
State/province [18] 0 0
Osaka
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo

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 a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 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 42 weeks.
Trial website
https://clinicaltrials.gov/study/NCT06326060
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/NCT06326060