A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
NCT ID: NCT06326060
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
355 participants
INTERVENTIONAL
2024-03-18
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dosing scheme a: NNC0519-0130
Participants will receive NNC0519-0130 at 1 dose level subcutaneously (s.c.) once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme a: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme b: NNC0519-0130
Participants will receive NNC0519-0130 at 2 dose levels s.c. once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme b: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme c: NNC0519-0130
Participants will receive NNC0519-0130 at 3 dose levels s.c. once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme c: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme d: NNC0519-0130
Participants will receive NNC0519-0130 at 4 dose levels s.c. once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme d: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme e: NNC0519-0130
Participants will receive NNC0519-0130 at 5 dose levels s.c. once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme e: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme f: NNC0519-0130
Participants will receive NNC0519-0130 at 6 dose levels s.c. once-weekly up to 36 weeks.
NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Dosing scheme f: Placebo
Participants will receive NNC0519-0130 matched placebo s.c. once-weekly up to 36 weeks.
Placebo
Placebo will be administered subcutaneously.
Dosing scheme g: Tirzepatide
Participants will receive tirzepatide at 6 dose levels s.c. once weekly up to 36 weeks.
Tirzepatide
Tirzepatide will be administered subcutaneously.
Interventions
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NNC0519-0130
NNC0519-0130 will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Tirzepatide
Tirzepatide will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Centricity Research-Arizona
Mesa, Arizona, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
FDRC
Costa Mesa, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Velocity Clin. Res Valparaiso
Valparaiso, Indiana, United States
L-MARC Research Center
Louisville, Kentucky, United States
Centennial Medical Group
Columbia, Maryland, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
NYU Bariatric Surgical Ctr
New York, New York, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Physicians East Endocrinology
Greenville, North Carolina, United States
Piedmont Healthcare
Statesville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Remington Davis Inc
Columbus, Ohio, United States
Family Practice Center of Wadsworth Inc.
Wadsworth, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
The University of Penn Center
Philadelphia, Pennsylvania, United States
Preferred Primary Care Physicians_Pittsburgh
Pittsburgh, Pennsylvania, United States
Velocity Clin Res Providence
East Greenwich, Rhode Island, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group Pc
Bristol, Tennessee, United States
Baylr Sctt White Rs Inst, Endo
Dallas, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
UT Southwestern Medical Center - Lingvay
Dallas, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
TPMG Clinical Research
Newport News, Virginia, United States
National Clin Res Inc.
Richmond, Virginia, United States
Paratus Clinical
Blacktown, New South Wales, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, Australia
Novatrials
Kotara, New South Wales, Australia
Paratus Clinical
Herston, Queensland, Australia
University of Sunshine Coast
Sippy Downs, Queensland, Australia
CMAX Clinical Research
Norwood, South Australia, Australia
Emeritus Research Melbourne
Camberwell, Victoria, Australia
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
OCROM Clinic
Suita-shi, Osaka, Japan
ToCROM Clinic
Tokyo, , Japan
Countries
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Other Identifiers
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U1111-1291-9210
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2051230198
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9541-5015
Identifier Type: -
Identifier Source: org_study_id
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