A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight

Last updated: June 3, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

2

Condition

Diabetes Prevention

Obesity

Treatment

Tirzepatide

NNC0519-0130

Placebo

Clinical Study ID

NCT06326060
NN9541-5015
U1111-1291-9210
jRCT2051230198
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Female of non-childbearing potential, or male. a. For US only: Female of childbearing potential using highly effective non-systemicmethods of contraception with low user-dependency at least 2 months prior toscreening 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 bodyweight.

  • a) BMI ≥ 27.0 kg/m2 with the presence of at least one weight-related co-morbidityincluding, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoeaor cardiovascular disease.

  • b) BMI ≥ 30.0 kg/m2.

Exclusion

Exclusion Criteria:

  • HbA1c greater than equal to 6.5% (48 millimoles per mole (mmol/mol)) as measured bythe central laboratory at screening.

  • History of type 1 or type 2 diabetes mellitus.

  • Treatment with any medication prescribed for the indication of obesity or weightmanagement within 90 days before screening.

Study Design

Total Participants: 355
Treatment Group(s): 3
Primary Treatment: Tirzepatide
Phase: 2
Study Start date:
March 18, 2024
Estimated Completion Date:
May 01, 2025

Connect with a study center

  • Paratus Clinical

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Northern Beaches Clinical Research

    Brookvale, New South Wales 2100
    Australia

    Site Not Available

  • Holdsworth House Clinical Research

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novatrials

    Kotara, New South Wales 2289
    Australia

    Site Not Available

  • Paratus Clinical

    Herston, Queensland 4006
    Australia

    Site Not Available

  • University of Sunshine Coast

    Sippy Downs, Queensland 4556
    Australia

    Site Not Available

  • CMAX Clinical Research

    Norwood, South Australia 5067
    Australia

    Site Not Available

  • Emeritus Research Melbourne

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Austin Health, Metabolic Disorders Centre

    Heidelberg Heights, Victoria 3081
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • OCROM Clinic

    Suita-shi, Osaka 565-0853
    Japan

    Site Not Available

  • ToCROM Clinic

    Tokyo, 160-0008
    Japan

    Site Not Available

  • Centricity Research-Arizona

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Arkansas Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Unity Health-Searcy Medical Center

    Searcy, Arkansas 72143
    United States

    Site Not Available

  • FDRC

    Costa Mesa, California 92627
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Univ of Colorado at Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Nature Coast Clinical Research

    Crystal River, Florida 34429
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Cedar-Crosse Research Center

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Velocity Clin. Res Valparaiso

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Centennial Medical Group

    Elkridge, Maryland 21075-6437
    United States

    Site Not Available

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • NYU Bariatric Surgical Ctr

    New York, New York 10016
    United States

    Site Not Available

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Physicians East Endocrinology

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Accellacare Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Remington Davis Inc

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Family Practice Center of Wadsworth Inc.

    Wadsworth, Ohio 44281-9236
    United States

    Site Not Available

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • The University of Penn Center

    Philadelphia, Pennsylvania 19104-3317
    United States

    Site Not Available

  • Preferred Primary Care Physicians_Pittsburgh

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • Medical University Of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Holston Medical Group Pc

    Bristol, Tennessee 37620-7352
    United States

    Site Not Available

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas 75226
    United States

    Site Not Available

  • North Texas Endocrine Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • UT Southwestern Medical Center - Lingvay

    Dallas, Texas 75390
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Site Not Available

  • National Clin Res Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

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