A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
Investigation of the Safety and Efficacy of Once Weekly NNC0519-0130 in Participants With Overweight or Obesity - a Dose Finding Study
3 other identifiers
interventional
354
3 countries
70
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Mar 2024
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2024
CompletedStudy Start
First participant enrolled
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedApril 15, 2026
April 1, 2026
1.1 years
March 16, 2024
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured in percentage of body weight.
From baseline (week 0) to end of treatment (week 36)
Secondary Outcomes (20)
Change in body weight
From baseline (week 0) to end of treatment (week 36)
Achievement of greater than equal to (≥) 5% weight reduction
From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 10% weight reduction
From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 15% weight reduction
From baseline (week 0) to end of treatment (week 36)
Achievement of ≥ 20% weight reduction
From baseline (week 0) to end of treatment (week 36)
- +15 more secondary outcomes
Study Arms (13)
Dosing scheme a: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
Dosing scheme a: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme b: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme b: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme c: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme c: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme d: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme d: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme e: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme e: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme f: NNC0519-0130
EXPERIMENTALParticipants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
Dosing scheme f: Placebo
PLACEBO COMPARATORParticipants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Dosing scheme g: Tirzepatide
ACTIVE COMPARATORParticipants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Interventions
NNC0519-0130 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (70)
Centricity Research-Arizona
Mesa, Arizona, 85206, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, 72143, United States
FDRC
Costa Mesa, California, 92627, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978, United States
UCLA Health Southbay Endocrine
Torrance, California, 90505, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Univ of Colorado at Denver
Aurora, Colorado, 80045, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, 46383, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303, United States
NYU Bariatric Surgical Ctr
New York, New York, 10016, United States
Rochester Clinical Research, Inc.
Rochester, New York, 14609, United States
Velocity Clinical Res. Inc Vestal
Vestal, New York, 13850, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408, United States
Physicians East Endocrinology
Greenville, North Carolina, 27834, United States
Piedmont Healthcare Statesville
Statesville, North Carolina, 28625, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Accellacare
Wilmington, North Carolina, 28401, United States
Velocity Clinical Res
Cleveland, Ohio, 44122, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
Providence Health Partners Ctr
Dayton, Ohio, 45439, United States
Centricity Research - Ohio
Dublin, Ohio, 43016, United States
Family Practice Center of Wadsworth Inc.
Wadsworth, Ohio, 44281-9236, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
The University of Penn Center
Philadelphia, Pennsylvania, 19104-3317, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, 15243, United States
Velocity Clin Res Providence
East Greenwich, Rhode Island, 02818, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352, United States
Baylr Sctt White Rs Inst, Endo
Dallas, Texas, 75226, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
UT Southwestern Medical Center - Lingvay
Dallas, Texas, 75390, United States
DCOL Ctr for Clin Res
Longview, Texas, 75605, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206, United States
Health Res of Hampton Roads
Newport News, Virginia, 23606, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Paratus Clinical
Bruce, Australian Capital Territory, 2617, Australia
Paratus Clinical
Blacktown, New South Wales, 2148, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010, Australia
Paratus Clinical
Kanwal, New South Wales, 2259, Australia
Novatrials
Kotara, New South Wales, 2289, Australia
Sutherland Shire Clinical Research
Miranda, New South Wales, 2228, Australia
University of Sunshine Coast
Birtinya, Queensland, 4575, Australia
Paratus Clinical
Herston, Queensland, 4006, Australia
University of Sunshine Coast
Morayfield, Queensland, 4506, Australia
University of Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
University of Sunshine Coast
South Brisbane, Queensland, 4101, Australia
Momentum Clinical Research
Taringa, Queensland, 4068, Australia
Momentum Clinical Research
Tarragindi, Queensland, 4121, Australia
CMAX Clinical Research
Norwood, South Australia, 5067, Australia
Emeritus Research Melbourne
Camberwell, Victoria, 3124, Australia
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, 3081, Australia
Momentum Clinical Research
St Albans, Victoria, 3021, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853, Japan
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2024
First Posted
March 22, 2024
Study Start
March 18, 2024
Primary Completion
April 10, 2025
Study Completion
May 1, 2025
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com