Clinical trial NCT06326060: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Official title: Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-03-22
Enrollment: 355
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 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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
Secondary outcomes:
measure: Change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of greater than equal to (≥) 5% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of ≥ 10% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of ≥ 15% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Achievement of ≥ 20% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in body mass index (BMI)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in fasting plasma glucose (FPG)
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: Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) Physical composite score
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in IWQOL-Lite-CT Psychosocial composite score
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in IWQOL-Lite-CT Physical Function score
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Change in IWQOL-Lite-CT Total score
timeFrame: From baseline (week 0) to end of treatment (week 36)
measure: Number of adverse events
timeFrame: From baseline (week 0) to end of treatment (week 40)
Other outcomes:
Locations:
city: Searcy
country: United States
facility: Unity Health-Searcy Medical Center
state: Arkansas
city: Costa Mesa
country: United States
facility: FDRC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clin. Res Valparaiso
state: Indiana
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Columbia
country: United States
facility: Centennial Medical Group
state: Maryland
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: Greensboro
country: United States
facility: Medication Mgmnt, LLC_Grnsboro
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Endocrinology
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth Inc.
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Philadelphia
country: United States
facility: The University of Penn Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians_Pittsburgh
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clin Res Providence
state: Rhode Island
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group Pc
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Res-Dallas
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Lingvay
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Newport News
country: United States
facility: TPMG Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
city: Blacktown
country: Australia
facility: Paratus Clinical
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Darlinghurst
country: Australia
facility: Momentum Clinical Research Darlinghurst
state: New South Wales
city: Kotara
country: Australia
facility: Novatrials
state: New South Wales
city: Herston
country: Australia
facility: Paratus Clinical
state: Queensland
city: Sippy Downs
country: Australia
facility: University of Sunshine Coast
state: Queensland
city: Norwood
country: Australia
facility: CMAX Clinical Research
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
city: Heidelberg Heights
country: Australia
facility: Austin Health, Metabolic Disorders Centre
state: Victoria
city: Suita-shi
country: Japan
facility: OCROM Clinic
state: Osaka
city: Tokyo
country: Japan
facility: ToCROM Clinic
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: